Jun
22
8:00 AM08:00

Blood Products Advisory Committee

In the morning open session, under Topic 1, the Committee will hear presentations on the research programs in the Laboratory of Emerging Pathogens (LEP), Laboratory of bacterial and TSE Agents (LBTSE), and from the Laboratory of Molecular Virology (LMV) in the Division of Emerging Transfusion-Transmitted Diseases (DETTD), Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER), FDA. After the conclusion of the open session, the meeting will be closed to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6). In the afternoon, in open session, under Topic II, the Committee will hear presentations on the research program in the Hemostasis Branch (HB), in the Division of Plasma Protein Therapeutics (DPPT), Office of Tissues and Advanced Therapies (OTAT), Center for Biologics Evaluation and Research (CBER), FDA. After the open session, the meeting will be closed to the public to permit discussion where disclosure would constitute an unwarranted invasion of personal privacy in accordance with 5 U.S.C 552b(c)(6).

View Event →
Jun
26
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

The Committees will discuss new drug application 022324, oxycodone extended-release capsules, submitted by Pain Therapeutics, with the proposed indication of the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The product is intended to have abuse-deterrent properties based on its physicochemical properties. The Committees will be asked to discuss whether the data submitted by the Applicant are sufficient to support labeling of the product with the properties expected to deter abuse.

View Event →
Jul
10
to Jul 11

Secretary’s Advisory Committee on Human Research Protections

On Tuesday, the Subpart A Subcommittee (SAS) and Subcommittee on Harmonization (SOH) subcommittees will present their recommendations regarding the description of “key information,” as required by the revised Common Rule at §46.116(a)(5)(i). This will be followed by a discussion of the application of the revised Common Rule’s exemptions at 46.104(d) to FDA-regulated research, and recommendations on the interpretation of §46.104(d)(1) and (2) for  the DHHS-funded research.

On Wednesday, the SAS subcommittee will present and discuss recommendations on the interpretation of “reasonably available” at §46.408(b), as well as discuss issues surrounding payment to subjects for participation in research. Modifications to the previous day’s work will be discussed and finalized.   

View Event →
Jul
18
to Jul 19

Blood Products Advisory Committee

On the first day of the meeting, the Committee will provide advice regarding bacterial risk control strategies to enhance the safety and availability of platelets for transfusion. On the second day of the meeting, the Committee, supplemented with members from the Microbiology Devices Panel of the Medical Devices Advisory Committee, will function as a medical device panel to provide advice and recommendations to the Agency on classification of devices.

View Event →
Jul
25
8:00 AM08:00

Pulmonary and Allergy Drugs Advisory Committee

The Committee will discuss supplemental biologics license application (sBLA) 125526 for mepolizumab for injection, submitted by GlaxoSmithKline for add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD) guided by blood eosinophil counts.

View Event →

Jun
20
8:00 AM08:00

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

The Committee will review and discuss a list of molecular targets for which evidence and/or biologic rationale exist to determine their potential relevance to the growth or progression of one or more pediatric cancers and a list of those targets deemed unlikely to be associated with the growth or progression of pediatric tumors.

View Event →
May
22
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

On Tuesday, May 22, 2018, the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) and the Drug Safety and Risk Management (DSRM) Advisory Committee voted not to recommend approval of buprenorphine sublingual spray (trade name Buvaya). The vote was 1-Yes to 18-No, with no abstentions

View Event →
May
17
8:00 AM08:00

Vaccines and Related Biological Products Advisory Committee

The Committee will discuss two topics related to biologic products. Under Topic I, the Committee will discuss approaches for demonstrating effectiveness of group B streptococcus (GBS) vaccines intended for use in pregnant women to protect the newborn infant.  Under Topic II, the committee will hear an overview of the research program in the Laboratory of Respiratory Viral Diseases (LRVD), Division of Viral Products, Office of Vaccines Research and Review, CBER, FDA.

View Event →
May
11
12:00 PM12:00

Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee

On Friday May 11, 2018 the Pediatric Advisory Committee (PEDAC) and the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) met jointly to discuss drug development for the treatment of children with achondroplasia. The following topics were discussed: evidence required to establish dose-response, study design, study duration, intended population, and endpoints.

From 8:00 am to 11:00 am, the meeting was closed to permit discussion and review of trade secret and/or confidential commercial information (5 U.S.C. 552b(c)(4)). During this session, the Committees discussed the premarketing drug development program of an investigational product.

Originally, this meeting was scheduled for March 22, 2018, but it was postponed due to inclement weather.

View Event →
May
10
8:00 AM08:00

Endocrinologic and Metabolic Drugs Advisory Committee

The Committee discussed the safety and efficacy of volanesorsen (VLN) solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc. (Akcea) for the treatment of patients with familial chylomicronemia syndrome (FCS). VLN was discovered by Ionis Pharmaceuticals, Inc. (Ionis), co-developed by Ionis and Akcea, and, if approved, will be commercialized by Akcea.

A majority of the Committee, 12 of 20 members, voted that, based on the information included in the briefing materials and presented at the meeting, Akcea has provided sufficient efficacy and safety data to support approval of volanesorsen.

The FDA’s PDUFA goal data to decide on approval is August 30, 2018.

View Event →
May
3
8:00 AM08:00

Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee

The Committee discussed a new drug application (NDA for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates grdeater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia. 21 of 24 members, voted that the overall risk-benefit profile of stannsoporfin does not support approval. Three of the 24 members did support approval with a REMS.

View Event →
May
2
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee voted unanimously (15 of 15 members) that Achaogen has provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of complicated urinary tract infections (cUTI) in patients with limited or no treatment options.

However, a majority of the Committee, 11 of 15 members, voted that Achaogen has not provided substantial evidence of the safety and effectiveness of plazomicin for the treatment of bloodstream infections (BSI) in patients with limited or no treatment options.

View Event →
May
1
10:00 AM10:00

Antimicrobial Drugs Advisory Committee

The Committee discussed and voted on a new drug application (NDA) for TPOXX (tecovirimat), sponsored by SIGA Technologies Inc. (SIGA), for the proposed indication of the treatment of smallpox disease caused by variola virus in adults and pediatric patients.
The Committee voted unanimously (17 of 17 members) that the available data for TPOXX (tecovirimat) support the risk-benefit profile for the proposed use to treat human smallpox.

View Event →
Apr
24
to Apr 25

Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee

The Committees met jointly to review and provide input on safety data from the PRECISION trial, a cardiovascular outcomes trial that compared Celebrex (celecoxib) to ibuprofen and naproxen, that was submitted by Pfizer, Inc. (Pfizer) in a supplemental new drug application (sNDA). The FDA also sought input on whether the findings of the trial should change the Agency’s current understanding of the safety of three nonsteroidal anti-inflammatory drugs (NSAIDs), including interpreting drug interactions between the three drugs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease.

View Event →
Apr
23
9:00 AM09:00

Science Board to FDA

The Science Board heard a report from the Center for Biologics Evaluation and Research Program Review Subcommittee; heard about FDA’s Patient Affairs Initiative; and discussed how the Agency can leverage its existing tools and authorities, and work with stakeholders, to better address the complex scientific, public health, and technology challenges it faces today.

View Event →
Apr
23
8:00 AM08:00

Arthritis Advisory Committee

The Committee voted in favor of approval of the proposed 2 mg dose of baricitinib tablets and against approval of the proposed 4 mg dose of baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arrthritis who have had an inadequate response or intolerance to methotrexate.

View Event →
Mar
23
8:30 AM08:30

POSTPONED FOR INCLEMENT WEATHER: Pediatric Advisory Committee

The Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA).

The Committee will meet to discuss the following products (listed by FDA Center):

(1) Center for Drug Evaluation and Research

a. BANZEL

b. INTUNIV

c. LEXAPRO

(2) Center for Devices and Radiological Health

a. FLOURISH (Humanitarian Device Exemption (HDE))

b. ACTIVA (HDE)

c. LIPOSORBER (HDE)

d. IMPELLA RP SYSTEM

View Event →
Mar
22
8:30 AM08:30

POSTPONED FOR INCLEMENT WEATHER: Pediatric Advisory Committee and Endocrinologic and Metabolic Drugs Advisory Committee

The PEDAC and EMDAC will meet to discuss the major objectives of a phase 3 drug development program indicated for the treatment of children with achondroplasia (ACH). 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.

View Event →
Mar
13
to Mar 14

Secretary's Advisory Committee on Human Research Protections

The US Department of Health and Human Services (HHS) has scheduled a meeting of the Secretary's Advisory Committee on Human Research Protections (SACHRP) on Tuesday to Wednesday, March 13-14, 2018. The Committee will review recommendations pertaining to the Common Rule and other topics related to human research protections.

View Event →
Mar
8
8:00 AM08:00

Gastrointestinal Drugs Advisory Committee

The Committee discussed a supplemental new drug application (sNDA) for Xeljanz (tofacitinib) tablets, by Pfizer Inc. (Pfizer), which proposed use for the treatment of adults with moderately to severely active ulcerative colitis with an inadequate response, loss of response or intolerance to conventional therapies [corticosteroids, azathioprine (AZA), 6-mercaptopurine (6-MP)] or tumor necrosis factor (TNF) blocker therapy.

The Committee agreed unanimously (15 of 15 members) with Pfizer’s proposed 10 mg twice-daily (BID) dosing as extended induction therapy for a total of 16 weeks in patients who have not achieved adequate therapeutic benefit by Week 8.

The Committee agreed unanimously (15 of 15 members) with Pfizer’s proposed 10 mg BID dosing as an option for continuous maintenance treatment for patients with a history of inadequate response, loss of response, or intolerance to TNF blocker therapy (TNF failures).

The Committee split its vote, with 8 members voting against and 7 members voting in favor, on requiring that Pfizer conduct a post-marketing efficacy trial in the population of TNF failures to compare the 10 mg BID continuous dosing regimen to a regimen of 10 mg induction and 5mg BID as maintenance.

View Event →
Mar
7
8:00 AM08:00

Oncologic Drugs Advisory Committee

A majority of the Committee, 8 of 12 members, voted that the results of the pivotal clinical trial, MT103-203, demonstrate that for patients with acute lymphoblastic leukemia (ALL) in complete response (CR) who have minimal residual disease (MRD) > 0.1%, treatment with blinatumomab provides a potential benefit that outweighs the risks from the treatment.

View Event →
Mar
1
8:00 AM08:00

Vaccines and Related Biological Products Advisory Committee

The Committee made recommendations on the selection of strains to be included in the influenza virus vaccine for the 2018 to 2019 influenza season in the US. The Committee agreed with the World Health Organization (WHO) strain recommendations for the 2018-2019 Northern Hemisphere influenza season.
In the first part of the meeting, the Committee heard an overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA.

View Event →
Feb
14
to Feb 15

Anesthetic and Analgesic Drugs Advisory Committee

The Committee met to discuss a supplemental new drug application (sNDA) for Exparel (bupivacaine liposomal injectable suspension), submitted by Pacira Pharmaceuticals, Inc. (Pacira). A majority of the Committee, 6 of 10 members, voted that the data submitted by Parica for Exparel do not support approval of an additional indication for nerve block.

View Event →
Feb
14
8:00 AM08:00

Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee

The Committees voted that Hydexor (proposed trade name), a fixed-dose combination oral tablet, submitted by Charleston Laboratories, Inc. (Charleston), should not be approved, by a vote of 2-Yes to 19-No, with no abstentions. Hydexor contains hydrocodone, acetaminophen, and promethazine, and is proposed for the short-term management of acute pain severe enough to require an opioid analgesic while preventing and reducing opioid-induced nausea and vomiting (OINV).

View Event →
Feb
8
9:30 AM09:30

Advisory Committee on Heritable Disorders in Newborns and Children

The meeting addressed address several topics related to heritable disorders and newborn screening, as follows:

  • Review and vote on whether to recommend adding spinal muscular atrophy (SMA) to the Recommended Uniform Screening Panel (RUSP)
  • States’ activities to achieve newborn screening (NBS) timeliness goals
  • Cutoff determinations and risk assessment methods for dried bloodspot newborn screening
  • Working group updates
  • Working group updates.
View Event →
Jan
11
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee did not support, by a vote of 3-Yes to 12-No, with one abstention, the safety and efficacy of LinhaliqTM (ciprofloxacin dispersion for inhalation - Cipro DI), sponsored by Aradigm Corp. (Aradigm), for the proposed indication of treatment of non-cystic fibrosis bronchiectasis (NCFB or NCFBE) patients with chronic lung infections with Pseudomonas aeruginosa (P. aeruginosa).

View Event →
Jan
10
8:00 AM08:00

Bone, Reproductive and Urologic Drugs Advisory Committee

The Committee did not support, by a vote of 6-Yes to 13-No, with no abstentions, the safety and efficacy of Tlando (oral testosterone undecanoate capsules), submitted by Lipocine Inc. (Lipocine) for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

View Event →
Jan
9
9:00 AM09:00

Bone, Reproductive and Urologic Drugs Advisory Committee

The Committee did not support, by a vote of 9-Yes to 10-No, with no abstentions, the safety and efficacy of Jatenzo (oral testosterone undecanoate capsules),submitted by Clarus Therapeutics, Inc. (Clarus) for the proposed indication of testosterone replacement in males for conditions associated with a deficiency or absence of endogenous testosterone: primary hypogonadism (congenital or acquired) and hypogonadotropic hypogonadism (congenital or acquired).

View Event →
Dec
7
8:00 AM08:00

Bone, Reproductive and Urologic Drugs Advisory Committee

The Committee discussed appropriate patient selection criteria and clinical trial design features, including acceptable endpoints, for demonstrating clinical benefit for drugs intended to treat interstitial cystitis and bladder pain syndrome. The Committee also discussed whether bladder pain syndrome and interstitial cystitis reflect overlapping or different populations, and whether it is appropriate to assess efficacy in the same way for both conditions.

View Event →