Apr
23
8:00 AM08:00

Arthritis Advisory Committee

The Committee will discuss a new drug application for baricitinib tablets, submitted by Eli Lilly and Company, for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. The discussion will include the following: efficacy, safety, including the risk of thromboembolic adverse events, dose selection, and overall risk benefit considerations.

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Apr
23
9:00 AM09:00

Science Board to FDA

The Science Board will hear a report from the Center for Biologics Evaluation and Research Program Review Subcommittee; hear about FDA’s Patient Affairs Initiative; and discuss 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
24
to Apr 25

Arthritis Advisory Committee and Drug Safety and Risk Management Advisory Committee

The Committees will discuss a supplemental new drug application (sNDA) for CELEBREX (celecoxib) capsules submitted by Pfizer, Inc., which includes the results from the PRECISION (Prospective Randomized Evaluation of Celecoxib Integrated Safety vs. Ibuprofen Or Naproxen) trial, a cardiovascular outcomes randomized controlled trial that compared celecoxib to ibuprofen and naproxen, and determine whether the findings of the trial change FDA’s current understanding of the safety of these three NSAIDs. In order to interpret some of the PRECISION findings, the Committees will also consider the clinical implications of the drug interactions between each of these three NSAIDs and aspirin in patients taking aspirin for secondary prevention of cardiovascular disease. 

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May
3
8:00 AM08:00

Gastrointestinal Drugs Advisory Committee and Pediatric Advisory Committee

The Committees will discuss a new drug application for stannsoporfin injection, for intramuscular use, submitted by InfaCare Pharmaceutical Corporation, proposed for the treatment of neonates greater than or equal to 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia.

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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

The Committees will be asked to discuss a new drug application for buprenorphine sublingual spray, submitted by INSYS Development Company, Inc., for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate. The Committees will also be asked to discuss whether this product should be approved.  

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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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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.

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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.

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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.

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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).

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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.
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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).

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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).

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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).

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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.

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Nov
30
to Dec 1

Blood Products Advisory Committee

The Committee discussed and voted on the following topics:

·         Bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion;

·         Device classification of human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices; and

·         Strategies to reduce the risk of transfusion-transmitted Zika virus.

The Committee also heard information about the April 6, 2017 FDA public workshop on emerging tick-borne diseases and blood safety, as well as the Transfusion Transmissible Infections Monitoring System.

 

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Nov
20
to Nov 21

Pharmacy Compounding Advisory Committee

The Committee reviewed substances nominated for the list of bulk substances allowed for compounding (a.k.a. the 503A Bulks List of the FD&C Act) and products nominated for the difficult to compound list (a.k.a., the Difficult to Compound List under sections 503A and 503B of the FD&C Act).

·      A majority of the Committee members agreed with the FDA’s recommendation to exclude the following four bulk drug substances from the list of bulk substances allowed for compounding: astragalus extract 10:1, 7-keto dehydroepiandrosterone, epigallocatechin gallate, and resveratrol.

·      A majority of the Committee members agreed with the FDA’s recommendation to include L-citrulline on the list of bulk substances allowed for compounding.

·      A slight majority of the Committee members did not agree with the FDA’s recommendation to exclude pregnenolone from the list of bulk substances allowed for compounding.

·      A majority of the Committee members agreed with the FDA’s recommendations to include liposome drug products and drugs produced using hot melt extrusion on the products that are demonstrably difficult to compound list.

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Nov
16
8:30 AM08:30

Antimicrobial Drugs Advisory Committee

On Thursday, November 16, 2017 the Antimicrobial Drugs Advisory Committee (AMDAC) did not support, by a vote of 6-Yes to 9-No, with no abstentions the safety and efficacy of the proposed 14-day regimen of ciprofloxacin dry powder inhaler (DPI), sponsored by Bayer HealthCare Pharmaceuticals, Inc. (Bayer), for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients with respiratory bacterial pathogens. The Committee did not support, by a vote of 1-Yes to 14-No, with no abstentions the proposed 28-day regimen.

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Nov
1
to Nov 2

Clinical Laboratory Improvement Advisory Committee

The Committee met to hear updates from the Centers for Disease Control and Prevention (CDC), the Centers for Medicare and Medicaid Services (CMS), and the Food and Drug Administration (FDA). In addition, the Committee heard presentations on laboratory testing in the era of telemedicine, antibiotic resistance testing issues, and culture independent diagnostic tests (CIDTs). The Committee also heard and discussed recommendations on sections of the Institute of Medicine (IOM) Report on Improving Diagnosis in Health Care, including IOM Workgroup topics of pathologists as integral care team member and interoperability.

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Oct
13
8:00 AM08:00

Dermatologic and Ophthalmic Drugs Advisory Committee

The Committee supported, by a vote of 9-Yes to 1-No, with no abstentions, the safety and efficacy of Rhopressa (netarsudil ophthalmic solution 0.02%), submitted by Aerie Pharmaceuticals Inc. (Aerie), for the proposed indication to reduce elevated intraocular pressure in patients with open-angle glaucoma (OAG) or ocular hypertension (OHT).

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Oct
12
8:00 AM08:00

Cellular, Tissue, and Gene Therapies Advisory Committee

The Committee unanimously supported, by a vote of 16-Yes to 0-No, with no abstentions, the safety and efficacy of voretigene neparvovec by Spark Therapeutics, Inc. (Spark). The proposed indication is the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy. The proposed trade name is Luxturna. The FDA’s goal date for a decision (PDUFA date) is January 12, 2018.

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