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Past Meetings

Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 9/20/16-9/21/16

Meeting Details:

On September 20 and 21, 2016, the Committee will discuss and make recommendations regarding the classification of certain wound care products containing antimicrobials and other drugs as part of the routine process for device classification. These products are regulated under product code FRO, "Dressing, Wound, Drug," and are considered "pre-amendments" because they were in commercial distribution prior to May 28, 1976, when the Medical Devices Amendments were enacted, and have not yet been classified under section 513 of the Federal Food, Drug, and Cosmetic Act. As a part of the classification process, FDA is seeking committee input on the indications for use, risks to health, and safety and effectiveness of these wound care products, and how they should be classified. They may be classified in class I (general controls), class II (special and general controls), or class III (premarket approval (PMA), requiring demonstration of safety and effectiveness for each product). FDA believes some of these products may meet the definition of class II whereas others may meet the definition of class III in light of their intended use, composition, the extent of evidence of clinical benefit, and the risks they pose. For the subset of the these products that contain antibiotics, FDA appreciates the importance of appropriately addressing the risk of antimicrobial resistance (AMR) in light of the increasingly significant national public health concern posed by AMR. FDA is also aware of differences in the claims made for some products even though they may be regulated in the same manner.

 

       
Location: Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 2/27/15-2/27/15

Meeting Details:

On February 27, 2015, the committee will discuss, make recommendations and vote on information regarding the premarket approval application (PMA) panel-track supplement to expand the indication for use for the Radiesse Injectable Implant (Radiesse) device to include subdermal implantation for hand augmentation to correct volume deficit in the hands. The proposed indication for use for the Radiesse device, as stated in the PMA is as follows: The Radiesse device is for hand augmentation to correct volume deficit in the hands. FDA has previously approved the Radiesse device for the following two indications for use: The Radiesse device is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. It is also indicated for subdermal implantation for restoration and/or correction of the signs of facial fat loss (lipoatrophy) in people with human immunodeficiency virus. The Radiesse device remains unchanged from the current FDA approved version.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/1/14-8/1/14

Meeting Details:

On August 1, 2014, the committee will discuss, make recommendations and vote on information regarding the premarket application (PMA) for the TissuGlu Surgical Adhesive device sponsored by Cohera Medical, Inc. The proposed indication for use for the TissuGlu Surgical Adhesive device, as stated in the PMA is as follows: TissuGlu Surgical Adhesive is indicated for the approximation of tissue layers where subcutaneous dead space exists between the tissue planes in large flap surgical procedures such as abdominoplasty.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 6/26/13-6/26/13

Meeting Details:

On June 26, 2013, the committee will discuss and make recommendations regarding the possible reclassification of blood lancet devices. The committee will discuss whether new scientific data are sufficient to support the reasonable assurance of safety and effectiveness to develop special controls that support regulation of blood lancets from class I to class II and class III. The four subsets of blood lancets have been identified with the following indications for use: • Blood lancet with an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which includes an integral sharps injury prevention feature that allows the device to be used once and then renders it inoperable and incapable of further use and which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet without an integral sharps injury prevention feature is for single use only, disposable blood lancet with a blade attached to a solid base which is used to puncture the skin to obtain a drop of blood for diagnostic purposes; • Blood lancet for single patient use only is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used only for a single patient to puncture the skin to obtain a drop of blood for diagnostic purposes; and 3 • Multiple use blood lancet for multiple patient use is a multiple use capable blood lancet with a single use blade inserted into a solid, reusable base which is used for multiple patients to puncture the skin to obtain a drop of blood for diagnostic purposes.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/2/13-5/2/13

Meeting Details:

On May 2, 2013, the committee will discuss, make recommendations and vote on information related to the premarket approval application for the Juv[eacute]derm Voluma XC sponsored by Allergan, Inc. Juv[eacute]derm Voluma XC is a dermal filler comprised of hyaluronic acid with lidocaine. Juv[eacute]derm Voluma XC is indicated for deep (dermal/subcutaneous and/or submuscular/ supraperiosteal) implantation to restore lost volume in the mid-face for aesthetic improvement.

 

       
Location: Hilton GB Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 6/21/12-6/21/12

Meeting Details:

On June 21, 2012, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Dune Medical Devices, Inc., for the MarginProbe System, that utilizes electromagnetic waves to characterize human tissue in real time and provides intraoperative information on the malignancy of the surface of the ex vivo lumpectomy specimen.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel of the Medical Devices

Meeting Date: 12/1/11-12/1/11

Meeting Details:

On December 1, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application, sponsored by Contura, Inc., for AQUAMID, a new material (polyacrylamide) for use as a dermal filler for aesthetic treatment of wrinkles in the face. The AQUAMID dermal filler is intended for use in mid-to-deep subdermal implantation for the aesthetic treatment of moderate to severe facial wrinkles and folds, such as the nasolabial folds. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/30/11-8/31/11

Meeting Details:

On August 30 and 31, 2011, the committee will discuss and make recommendations on postmarketing issues related to silicone gel-filled breast implants. This meeting is regarding the discussion of different innovative methodological approaches to the conduct of postmarket studies regarding silicone gel breast implants. Additionally, the panel will discuss key long-term safety issues associated with silicone gel breast implants in the real-world setting.

 

       
Location: Hilton Washington DC North/Gaithersburg Related News Links: Not Available
Time: 8:00AM-4:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 4/27/11-4/27/11

Meeting Details:

On April 27, 2011, the committee will discuss, make recommendations, and vote on information related to the premarket approval application supplement for RESTYLANE, sponsored by Medicis Aesthetics, Inc. RESTYLANE is currently approved for mid- to deep-dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds. The sponsor is requesting an expanded indication, to include use of RESTYLANE for augmentation of the lips.

 

       
Location: Holiday Inn Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/18/10-11/18/10

Meeting Details:

On November 18, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application for MelaFind, sponsored by MELA Sciences. MelaFind(R) is a non-invasive and objective multi-spectral computer vision system designed to aid physicians in the detection of early melanoma from among clinically atypical (those having one or more clinical or historical characteristics of melanoma, such as asymmetry, border irregularity, color variegation, diameter greater than 6 millimeters, evolving, patient concern, regression, and ``ugly duckling'') cutaneous pigmented lesions that are non-ulcerated, not bleeding, and less than 2.2 centimeters in diameter, when a physician chooses to obtain additional information before making a final decision to biopsy to rule out melanoma.

 

       
Location: Holiday Inn College Park College Park, MD. Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/10-3/25/10

Meeting Details:

On March 25, 2010, the committee will review and discuss recent information, including recent literature regarding the possible risks to the general public from intentional exposure to ultraviolet radiation (UV) from use of tanning lamps. There continues to be a growing body of literature showing association of skin cancer with use of tanning lamps and the committee will discuss this information and other information related to the association of UV and skin cancer (both melanoma and non-melanoma). The committee will be asked to recommend whether changes to current classification or current regulatory controls of UV emitting devices (lamps) used for tanning are needed.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/18/08-11/19/08

Meeting Details:

On November 18, 2008, the committee will receive an update on safety information collected on dermal fillers in the commercial setting, discuss current premarket and postmarket approved study designs, and make recommendations on general issues concerning the study of various dermal fillers. In addition, the committee will discuss the design of clinical trials for future premarket submissions seeking approval of dermal fillers for new intended uses. On November 19, 2008, the committee will discuss and make recommendations on general issues related to the clinical trials of cosmetic devices. Specifically, the committee will make recommendations on how to quantify the effects of devices with various types of energy sources, such as light-based products, light-based combination devices, ultrasound devices (including focused ultrasound devices), massagers combined with other energy modalities, cryogenic energy devices, radiofrequency ablation devices, and microwave systems, on dermatologic conditions.

 

       
Location: Rio Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/24/06-8/25/06

Meeting Details:

On August 24, 2006, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients and a second PMA for the same device intended for use as a filler material to restore soft tissue facial contours such as nasolabial folds. On August 25, 2006, the committee will discuss and make recommendations on the reclassification, to Class II, of a Class III medical device: cyanoacrylate tissue adhesive.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 8/25/05-8/26/05

Meeting Details:

On August 25, 2005, the committee will hear a presentation on the FDA Critical Path Initiative and a presentation by the Office of Surveillance and Biometrics in the Center for Devices and Radiological Health outlining their responsibility for the review of postmarket study design. On August 25 and 26, 2005, the committee will discuss and make recommendations on the classification of five preamendments medical devices: Bone wax, medical maggots, medicinal leeches, tissue expander, and wound dressing with a drug.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsInamed & Mentor - General & Plastic Surgery

Meeting Date: 4/11/05-4/13/05

Meeting Details:

On April 11, 2005, the committee will hear oral presentations from the public. On April 12 and 13, 2005, the committee will discuss, make recommendations, and vote on two premarket approval applications for Silicone Gel-Filled Breast Prostheses. Related Link From Inamed. Also Mentor will be presenting: Related Link From Yahoo

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 5/12/04-5/12/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an in situ polymerizable sealant material intended to be used to seal air leaks following pulmonary surgery.

 

       
Location: Holiday Inn, GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 3/25/04-3/25/04

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for an injectable device intended for use in the correction of lipoatrophy of the face in HIV (human immunodeficiency virus) positive patients.

 

       
Location: Hilton Washington Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 11/21/03-11/21/03

Meeting Details:

The committee will discuss, make recommendations, and vote on two premarket approval applications (PMAs) for injectable devices intended to restore soft tissue facial contours such as nasolabial folds.

 

       
Location: HOL Gaithersburg , MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 10/14/03-10/15/03

Meeting Details:

On October 14 and 15, 2003, the committee will discuss, make recommendations, and vote on a premarket approval application for Silicone Gel-Filled Breast Prostheses.

 

       
Location: Marriott Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-10:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 7/24/03-7/24/03

Meeting Details:

The committee will discuss and make recommendations on the reclassification of a transitional class III device, the absorbable hemostatic agent and dressing device intended for hemostasis during surgical procedures. There will also be a discussion of a general issue: clinical trial issues for devices designed for percutaneous removal of breast tumors.

 

       
Location: Hilton - GB Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 2/28/03-2/28/03

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an injectable wrinkle treatment device. There will also be a discussion of two general issues: (1) clinical trial issues for devices designed for ablation of pulmonary tumors, and 2) clinical trial issues for devices designed for the treatment of emphysema.

 

       
Location: Hilton Gaithersburg , MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 7/8/02-7/9/02

Meeting Details:

On July 8, 2002, the committee will discuss and make recommendations on the classification of a preamendment device, the silicone elastomer for scar management. The committee will also discuss and make recommendations on the reclassification of a transitional class III device, the absorbable hemostatic agent and dressing device intended for hemostasis during surgical procedures. On July 9, 2002, the FDA and two manufacturers of approved saline inflatable breast implant devices will present postmarket information to the committee for their consideration.

 

       
Location: Holiday Inn Gaithersburg, MD Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral and Plastic Surgery Devices Panel

Meeting Date: 7/17/01-7/17/01

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an Interactive Wound and Burn Dressing.

 

       
Location: Hilton Gaithersburg, MD Related News Links: Not Available
Time: 1:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 5/8/00-5/8/00

Meeting Details:

The committee will discuss, make recommendations, and vote on two premarket approval applications: 1) for an in situ polymerizable surgical mesh intended to be used to seal air leaks following thoracic cavity surgery; and 2) for an interactive wound and burn dressing intended to be used for the treatment of diabetic foot ulcers by FocalSeal.

 

       
Location: Gaithersburg Marriott Washingtonian Center Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 3/1/00-3/3/00

Meeting Details:

On March 1, 2000, there will be a brief FDA presentation on the Least Burdensome provisions of the FDA Modernization Act of 1997. Also on March 1, 2000, the committee will discuss, make recommendations, and vote on a premarket approval application (PMA) for Saline Inflatable Breast Prostheses. On March 2, 2000, the committee will discuss, make recommendations and vote on two PMAs for Saline Inflatable Breast Prostheses. On March 3, 2000, the committee will discuss content, format, and consistency issues involving the labeling information provided to patients considering saline-filled breast prostheses.

 

       
Location: Gaithersburg, MD. Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 1/12/00-1/12/00

Meeting Details:

The committee will discuss, make recommendations, and vote on a premarket approval application for an Absorbable Adhesion Barrier Device.

 

       
Location: Corporate Bldg. Rockville, MD. Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 8/2/99-8/2/99

Meeting Details:

The committee will discuss possible revisions to the 1995 draft guidance

 

       
Location: Corporate Bldg., conference room 020B, 9200 Corpor Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 6/16/99-6/16/99

Meeting Details:

On June 16, 1999, the committee will discuss, make recommendations and vote on premarket approval application for computer-guided surgical instruments for use in endoscopic surgery. *** Call for Satellite, Videoconferencing and Webcasting ***

 

       
Location: Gaithersburg Hilton, Salons C, D, and E, 620 Perry Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsGeneral & Plastic Surgery Devices

Meeting Date: 11/17/98-11/17/98

Meeting Details:

The committee will discuss and make recommendations on a proposal for the classification of preamendment wound dressing medical devices based on: 1) a proposed rule published in the Federal Register of September 19, 1989 (54 FR 38600); 2) comments received in response to the proposed rule; and 3)comments from the General and Plastic Surgery Devices Panel Meeting of July 20, 1995. The committee will also discuss and make recommendations on the reclassification of preamendment class III topical oxygen devices for woundhealing on extremities based on information received from a call for safety and effectiveness information under section 515(I) published in the Federal Registers of August 14, 1995 and June 13, 1997 (60 FR 41986 and 62 FR 32355, respectively).

 

       
Location: FDA Corporate Blvd., Gaithersburg, MD Related News Links: Not Available
Time: 9:00AM-5:00PM    
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Upcoming Meetings

Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsNeurological Devices Panel of the Medical Devices

Meeting Date: 3/1/18-3/1/18

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Meeting Details:

On March 1, 2018, the committee will discuss, make recommendations, and advise FDA regarding the evaluation of clinical study data to support the safety and effectiveness of intracranial aneurysm treatment devices and factors that can affect clinical outcomes such as aneurysm morphology, size, and location in the neurovasculature. FDA is also convening this committee to seek expert opinion on the scientific and clinical considerations relating to the clinical trial design that may be relevant to the determination of safety and effectiveness for these devices.

 

       
Location: Hilton Gaithersburg MD Related News Links: Not Available
Time: 8:00AM-6:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsRisk Communication AdComm

Meeting Date: 3/5/18-3/6/18

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Meeting Details:

Day 1 - The committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The Pregnancy and Lactation Labeling Rule (PLLR) was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation. The Agency seeks input and recommendations on: how information in PLLR labeling is being perceived and used by health care providers and other stakeholders, factors that are critical to health care providers’ interpretation of the data and counseling of pregnant women on the risks and benefits of a medication, and how to convey risk information to health care providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy. Day 2 - The committee will discuss the impact of pregnancy and lactation labeling information in prescription drug and biological products as modified under the Pregnancy and Lactation Labeling Rule. The Pregnancy and Lactation Labeling Rule (PLLR) was implemented in June 2015, and required changes to labeling of information in prescription drug and biological products to better communicate clinically relevant information to health care providers on risks associated with medication exposure during pregnancy and lactation. The Agency seeks input and recommendations on: how information in PLLR labeling is being perceived and used by health care providers and other stakeholders, factors that are critical to health care providers’ interpretation of the data and counseling of pregnant women on the risks and benefits of a medication, and how to convey risk information to health care providers to accurately and adequately inform risk-benefit considerations for medication use during pregnancy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsOncologic Drugs AdComm

Meeting Date: 3/7/18-3/7/18

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Meeting Details:

The committee will discuss supplemental biologic license application (sBLA) 125557/S-013, for BLINCYTO (blinatumomab) injection for intravenous use, application submitted by Amgen, Inc. The proposed indication (use) for this product is for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-1:00AM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsGastrointestinal Drugs AdComm

Meeting Date: 3/8/18-3/8/18

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Meeting Details:

The committee will discuss supplemental new drug application (sNDA) 203214, supplement 18, XELJANZ (tofacitinib) 5 mg and 10 mg tablets, submitted by Pfizer Inc., proposed for the treatment of adult patients with moderately to severely active ulcerative colitis who have demonstrated an inadequate response, loss of response or intolerance to corticosteroids, azathioprine, 6-mercaptopurine or tumor necrosis factor (TNF) inhibitor therapy.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsPediatric AdComm

Meeting Date: 3/22/18-3/23/18

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Meeting Details:

On Thursday, March 22, 2018, the Pediatric Advisory Committee (PAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH) submitted by BioMarin Pharmaceutical Inc. The following elements of a phase 3 program should be considered for discussion: evidence required to establish dose-response, study design, e.g., placebo control, study duration, intended population, e.g., infants and toddlers and/or older children and adolescents, and endpoints that have a clinically meaningful impact on the patient’s functional or psychological well-being. On Friday, March 23, 2018, the Pediatric Advisory Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act of 2003. The Pediatric Advisory Committee will meet to discuss the following products (listed by FDA Center): 1) Center for Drug Evaluation and Research BANZEL, INTUNIV, LEXAPRO 2) Center for Devices and Radiological Health FLOURISH (HDE), ACTIVA (HDE), LIPOSORBER (HDE), IMPELLA RP SYSTEM (HDE)

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:30AM-5:00PM    
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Meeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsMeeting OptionsEndocrinologic and Metabolic Drugs AdComm

Meeting Date: 5/10/18-5/10/18

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Meeting Details:

The committee will discuss the safety and efficacy of new drug application (NDA) 210645, for volanesoren solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. The proposed indication is as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Recent Meetings

Meeting OptionsMeeting OptionsMeeting OptionsJoint Meeting Anesthetic & Analgesic with DSRM AdComm

Meeting Date: 2/14/18-2/15/18

Meeting Details:

The committees will be asked to discuss new drug application (NDA) 209257, proposed tradename, HYDEXOR, a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc., that contains hydrocodone, acetaminophen, and promethazine, for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting. The committees will also be asked to discuss the abuse potential of this non-abuse-deterrent product and whether it should be approved. The committee will discuss supplemental new drug application (sNDA) 022496/S-009, for EXPAREL (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia.

 

       
Location: FDA Meeting Room Related News Links: Not Available
Time: 8:00AM-5:00PM    
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Past Meetings

Below is a listing of all committees. Select a committee to display all meetings available for that committee.

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