Sep
12
8:00 AM08:00

Pharmacy Compounding Advisory Committee

The committee will receive information on the following two issues to follow-up on discussions from previous PCAC meetings: balancing the criteria for the 503A bulk drug substance evaluation and compounding as it relates to dietary supplements. In addition, the committee will discuss six bulk drug substances nominated for inclusion on the 503A Bulks List. FDA will discuss the following nominated bulk drug substances: alpha lipoic acid, coenzyme Q10, creatine monohydrate, pyridoxal 5 phosphate, choline chloride, and quercetin. The list below identifies the use(s) FDA reviewed for each of the six bulk drug substances being discussed at this advisory committee meeting. The nominators of these substances will be invited to make a short presentation supporting the nomination.

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Aug
8
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee discussed new drug applications (NDAs) for omadacycline tablets and injection, sponsored by Paratek Pharmaceuticals, Inc. (Paratek), for the proposed indications for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

A majority of the Committee, 17 of 18 members, voted that Paratek has provided substantial evidence of the safety and effectiveness of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

A majority of the Committee, 14 of 18 members, voted that Paratek has also provided evidence of the safety and effectiveness of omadacycline for the treatment of community acquired bacterial pneumonia (CABP).

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Aug
7
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee discussed a new drug application (NDA) for amikacin liposome inhalation suspension (ALIS), sponsored by Insmed, Inc. (Insmed), for the proposed indication of treatment of nontuberculous mycobacterial (NTM) lung disease caused by Mycobacterium avium complex (MAC) in adults, as part of a combination antibacterial drug regimen.

A majority of the Committee, 12 of 14 members, voted that Insmed has provided substantial evidence of the effectiveness and sufficient evidence of the safety of ALIS for the treatment of nontuberculous mycobacterial lung disease caused by MAC, as part of a combination antibacterial drug regimen, for adult patients with limited or no treatment options. A same majority of the Committee, 12 of 14 members, did not support broader use for all adult patients with the disease.

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Jul
26
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee discussed a new drug application (NDA) for tafenoquine tablets, sponsored by 60 Degrees Pharmaceuticals, LLC (60 Degrees), for the proposed indication of prevention of malaria in adults for up to 6 months of continuous dosing.

A majority of the Committee, 11 of 13 members, voted that 60 Degrees has provided substantial evidence of the effectiveness of tafenoquine for the proposed use.

A slightly lesser majority of the Committee, 9 of 13 members, voted that 60 Degrees has provided adequate evidence of the safety of tafenoquine for the proposed use.

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Jul
25
8:00 AM08:00

Pulmonary and Allergy Drugs Advisory Committee

The Committee discussed a supplemental biologics license application (sBLA) for Nucala (mepolizumab), by GlaxoSmithKline (GSK), which proposed use as an 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.

·      A majority of the Committee, 16 of 19 members, voted that the benefit-risk profile is not adequate to support approval of mepolizumab for the proposed use.

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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.

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Jul
12
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

The Committee voted unanimously (13 of 13 members) that GSK has provided substantial evidence of the effectiveness of tafenoquine for the radical cure (prevention of relapse) of P. vivax malaria in patients 16 years of age and older. T

A majority of the Committee, 12 of 13 members, voted that GSK has provided adequate evidence of the safety of tafenoquine for the proposed use.

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Jun
26
8:00 AM08:00

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

A majority of the joint Committee, 14 of 17, voted to recommend against the approval of Pain Therapeutics’ Remoxy ER (oxycodone extended-release capsules).
The proposed indication of Remoxy ER is 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 properties that deter abuse by the intranasal and intravenous routes of abuse, based on physicochemical properties of its formulation.

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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).

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Jun
20
8:00 AM08:00

Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee

The Committee reviewed and discussed 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.

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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

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May
17
8:00 AM08:00

Vaccines and Related Biological Products Advisory Committee

The US FDA has scheduled a Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for Thursday, May 17, 2018, to 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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

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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.

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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.

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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.

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