Nov
30
to Dec 1

Blood Products Advisory Committee

On November 30, 2017, the Committee members will meet in open session to discuss bacterial risk control strategies for blood collection establishments and transfusion services to enhance the safety and availability of platelets for transfusion. In the afternoon, the Committee will be seated as a device classification panel. In open session, the panel will discuss the appropriate device classification of human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices. On December 1, 2017, the committee members will meet in open session to discuss strategies to reduce the risk of transfusion-transmitted Zika virus. In the afternoon, an information session on the Transfusion Transmissible Infections Monitoring System will be presented to the Committee. Finally, the Committee will hear an update presentation on the April 6, 2017, FDA public workshop on emerging tick-borne diseases and blood safety.

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Dec
7
8:00 AM08:00

Bone, Reproductive and Urologic Drugs Advisory Committee

The Committee will discuss 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 will also discuss 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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Jan
9
9:00 AM09:00

Bone, Reproductive and Urologic Drugs Advisory Committee

The Committee will discuss a new drug  application for oral  testosterone undecanoate  capsules,  submitted by  Clarus Therapeutics, for the proposed indication  of testosterone replacement in males for conditions associated with a deficiency or absence of  endogenous tes osterone: Primary hypogonadism (congenital or acquired) and hypogonadotropic  hypogonadism (congenital or acquired). 

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Jan
10
8:00 AM08:00

Bone, Reproductive and Urologic Drugs Advisory Committee

The Committee will discuss a new drug application for oral testosterone undecanoate capsules, submitted by Lipocine Inc. 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 hypogonadotropichypogonadism (congenital or acquired).

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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) supported/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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Sep
28
8:00 AM08:00

Peripheral and Central Nervous System Drugs Advisory Committee

The Committee met to discuss the proposed use of Translarna (ataluren) by PTC Therapeutics (PTC) for the treatment of dystrophinopathies resulting from nonsense mutations in the dystrophin gene, including nonsense mutation Duchenne Muscular Dystrophy (nmDMD). A majority of the Committee, 10 of 11 members, voted that “although it is possible that ataluren may be effective, the data are inconclusive, and more work would be needed to establish whether ataluren is effective.”

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Sep
19
8:00 AM08:00

Oncologic Drugs Advisory Committee

The Committee split their vote, by a vote of 6-Yes to 6-No, with no abstentions, on the benefit-risk profile of Sutent (sunitinib malate), submitted by C.P. Pharmaceuticals International CV, represented by Pfizer, Inc. (authorized US agent) for the proposed indication of adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma (RCC) following nephrectomy.

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Sep
14
8:00 AM08:00

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

The Committees discussed a supplemental new drug application (sNDA) for Butrans (buprenorphine transdermal system, BTDS) submitted by Purdue Pharma L.P. (Purdue), evaluating Butrans in pediatric patients aged 7 through 16 years for management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. The Committees were specially asked to discuss the findings of the clinical study of Butrans conducted in pediatric patients, and whether they support additional labeling.

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Sep
11
to Sep 12

Pediatric Advisory Committee

On Monday, September 11, 2017, the Pediatric Advisory Committee (PEDAC) discussed and voted on the use of prescription opioid products for the treatment of cough in pediatric patients.

On Tuesday, September 12, 2017, the Committee discussed and voted on pediatric-focused safety reviews for certain products that are mandated by the Best Pharmaceuticals for Children Act (BPCA), the Pediatric Research Equity Act (PREA), and the Pediatric Medical Device Safety and Improvement Act (PMDSIA).

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Sep
8
7:30 AM07:30

Medical Imaging Drugs Advisory Committee

The Committee discussed the potential risk of gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) procedures. A majority of the Committee agreed with the plans that were proposed by the FDA to address this potential risk, which included labeling and potentially requiring further additional safety studies.

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Aug
3
8:00 AM08:00

Arthritis Advisory Committee

The Committee supported by a vote of 10-Yes to 1-No, with no abstentions, the approval of XELJANZ (tofacitinib) tablets and XELJANZ XR (tofacitinib) extended-release (XR) tablets, submitted by Pfizer Inc. (Pfizer), for the treatment of adult patients with active psoriatic arthritis.

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Aug
2
8:00 AM08:00

Arthritis Advisory Committee

The Committee voted against recommending approval, by a vote of 1-Yes to 12-No, with no abstentions, of sirukumab injection (proposed trade name PLIVENSIA), by Janssen Biotech, Inc. (Janssen), for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response or are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs).

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Jul
26
8:00 AM08:00

Anesthetic and Analgesic Drugs Advisory Committee and Drug Safety and Risk Managment Advisory Committee

The Committees voted that Rexista (oxycodone extended-release tablets), submitted by Intellipharmaceutics Corp. (Intellipharmaceutics) should not be approved, by a vote of  1-Yes and 22-No,. The proposed indication of Rexista is the management of moderate-to-severe pain when a continuous around-the-clock analgesic is needed for an extended period of time. The Committees also voted in regard to the company’s proposed label claim regarding abuse-deterrence. The FDA’s decision goal date for the Rexista New Drug Application (NDA) is September 25, 2017.

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Jul
25
to Jul 26

Secretary's Advisory Committee on Human Research Protections

On Tuesday and Wednesday, July 25-26, 2017, the Secretary’s Advisory Committee on Human Research Protections (SACHRP) met to discuss topics related to human research protections. The Committee reviewed recommendations pertaining to the new Common Rule, the Federal Policy for the Protection of Human Subjects under 45 CFR, Part 46.

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Jul
13
8:00 AM08:00

Oncologic Drugs Advisory Committee

In the morning session, the Committee supported, by a vote of 17-Yes to 0-No, with no abstentions, the licensure of ABP-215 as a biosimilar to Genentech/Roche’s Avastin (bevacizumab), submitted by Amgen Inc. (Amgen). Amgen has developed ABP-215 in collaboration with Allergan.

In the afternoon session, the Committee supported, by a vote of 16-Yes to 0-No, with no abstentions, the licensure of MYL-1401O as a biosimilar to Genentech Inc.’s Herceptin (trastuzumab), submitted by Mylan GmbH (Mylan). Mylan is developing MYL-1401O in collaboration with Biocon Ltd.

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Jul
12
8:00 AM08:00

Oncologic Drugs Advisory Committee

The Committee supported, by a vote of 10-Yes to 0-No, with no abstentions, the safety and efficacy of tisagenlecleucel by Novartis Pharmaceuticals Corp. (Novartis) for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory (r/r) B-cell precursor acute lymphoblastic leukemia (ALL).

The PDUFA date, which is the FDA’s goal date to make an approval decision, is October 3, 2017.

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Jun
21
to Jun 22

Pediatric Subcommittee of the Oncologic Drugs Advisory Committee

The Committee (ODAC) discussed potential pediatric development plans/written requests for: (1) APX005M, presentation by Apexigen, Inc. (Apexigen); (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc. (PharmaMar); (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. (Astellas); (4) Prexasertib, presentation by Dista Products/Eli Lilly and Company (Lilly); and (5) Olaratumab, presentation by Eli Lilly and Company.

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