Oct
17
to Oct 18

Secretary's Advisory Committee on Human Research Protections

On Tuesday, the Subpart A Subcommittee (SAS) will present their recommendations regarding the revised Common Rule’s expedited review requirements. This will be followed by a discussion of the meaning of “context” when considering requirement for single IRB review. This will be followed by a discussion of SOH 3 recommendations on the revised Common Rule’s HIPAA exemption, section 104(d) (4) (iii), and a panel discussion with a representative of the Office for Civil Rights. The day will conclude with a presentation by OHRP staff on a new public outreach website,

On Wednesday, the meeting will begin with a presentation and discussion led by FDA staff on a recent FDA experience with IRB review under 21 CFR 50.54, and the lessons learned.

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Nov
8
to Nov 9

Advisory Committee on Heritable Disorders in Newborns and Children

The meeting agenda will include: (1) an update on states’ progress toward the newborn screening timeliness goals outlined by the Committee; (2) a presentation on phase 2 of the spinal muscular atrophy evidence review; (3) presentations on newborn screening topics such as the clinical and public health impact of Severe Combined Immunodeficiency (SCID), carrier status in the context of newborn screening, and a review of long term follow up in newborn screening; and (4) updates from the Laboratory Standards and Procedures workgroup, Follow-up and Treatment workgroup, and Education and Training workgroup. The Committee will not be voting on a proposed addition of a condition to the RUSP.

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Nov
16
8:30am 8:30am

Antimicrobial Drugs Advisory Committee

The Committee will discuss a new drug application for ciprofloxacin inhalation powder, sponsored by Bayer HealthCare Pharmaceuticals, Inc., for the proposed indication of reduction of exacerbations in non-cystic fibrosis bronchiectasis (NCFB) adult patients (≥18 years of age) with respiratory bacterial pathogens.

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Dec
7
8:00am 8:00am

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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Oct
13
8:00am 8:00am

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
8:00am 8:00am

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
8:00am 8:00am

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
8:00am 8:00am

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
8:00am 8:00am

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
7:30am 7:30am

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
8:00am 8:00am

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
8:00am 8:00am

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
8:00am 8:00am

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
8:00am 8:00am

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
8:00am 8:00am

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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May
25
to May 26

Secretary's Advisory Committee on Human Research Protections

The Committee 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) and recent FDA Draft Guidance regarding the use of real-world evidence to support regulatory decision-making for medical devices.

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May
24
8:00am 8:00am

Oncologic Drugs Advisory Committee

The Committee supported by a vote of 12-Yes to 4-No, with no abstentions, the risk-benefit profile of neratinib maleate by Puma Biotechnology (Puma) for the extended adjuvant treatment of human epidermal growth factor receptor 2 (HER2)-overexpressed/amplified in adult breast cancer patients who have received prior therapy with trastuzumab (US trade name Herceptin).

In the afternoon session, the Committee supported, by a vote of 10-Yes to 3-No, with no abstentions, the risk-benefit profile of L-glutamine by Emmaus Medical, Inc. (Emmaus) for the treatment of Sickle Cell Disease.

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May
18
8:30am 8:30am

Pediatric Advisory Committee and Pediatric Ethics Subcommittee

The Committees jointly supported, by a vote of 14-Yes to 0-No, with no abstentions, the use of an indwelling central venous access devices, in certain circumstances, in the clinical trial “A Double-Blind, Placebo-Controlled, Multicenter Study With an Open-Label Extension to Evaluate the Efficacy and Safety of SRP-4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy (ESSENCE).”

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May
9
2:00pm 2:00pm

Science Board to the FDA

The Board met to provide recommendations on the Agency’s work plan on the allocation of innovation funds. Section 1002 of the 21st Century Cures Act provides $495 million in funding to the FDA from fiscal year (FY) 2017 through FY 2025 for FDA Innovation Projects. The Act requires the FDA Commissioner to submit a work plan that describes the budget for planned activities and provides justification based on advancing public health. The plan must be submitted by June 11, 2017, which is within 180 days of the bill’s passage (December 13, 2016). The Act states that prior to submitting the work plan to Congress, the Commissioner must seek recommendations from the SBFDA and include these recommendations in the work plan.

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May
8
to May 9

Pharmacy Compounding Advisory Committee

The Committee discussed and voted on substances that were nominated for the list of bulk drug substances allowed for compounding and on products that were nominated for the difficult to compound list (as per sections 503A and 503B of the Food, Drug & Cosmetic Act).

·         A majority of the Committee members agreed with the FDA’s recommendation to exclude the following 6 bulk drug substances on the substances allowed list: nicotinamide adenine dinucleotide, nicotinamide adenine dinucleotide disodium reduced, nettle, ubiquinol, vanadyl sulfate, and artemisinin.

·         A majority of the Committee members agreed with the FDA’s recommendation to include oral solid modified release drug products that employ coated systems on the products that are difficult to compound list.

·         The Committee also heard an update from the FDA in regard to inspections.

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