1) Recombinant Human Coagulation Factor IX, GlycoPEGylated 2) Blood Donor Deferral Policy for Reducing the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products 3) Research programs in the Laboratory of Emerging Pathogens in the Division of Emerging Transfusion-Transmitted Diseases
Read MoreMAR 15-16 SACHRP
1) Common Rule 2) Real-world evidence for devices
Read MoreFEB 9 ACHDNC
Newborn screening topics
Read MoreMAR 13-14 AADPAC-DSRM
1) Safety issues with Endo's OPANA ER (extended-release (ER) oxymorphone) 2) abuse of generic oxymorphone ER and oxymorphone immediate-release (IR) products
Read MoreFEB 16 PDAC
Valbenazine for the proposed treatment of Tardive Dyskinesia, submitted by Neurocrine Biosciences, Inc.
Read MoreMAR 15 ACPS-CP
Model-informed drug development
Read MoreNOV 15 SBFDA
The Science Board will hear about: (1) The Center for Biologics Evaluation and Research’s strategic goals for regulatory science; (2) a progress update on FDA’s Opioid Action Plan and the Bovine Heparin Initiative; (3) a response from the Office of Scientific Professional Development to the Science Board’s report on the Commissioner’s Fellowship Program; (4) a report from the Scientific Engagements Subcommittee; and (5) a report from the Food Emergency Response Network Cooperative Agreement Program Evaluation Subcommittee.
Read MoreDEC 6 BRUDAC
Clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadism while preserving or improving testicular function, including spermatogenesis
Read MoreNOV 7 RCAC
FDA’s draft Strategic Plan for Risk Communication and Health Literacy
Read MoreAUG 25-26 ACHDNC
Impact of sequencing on newborn screening, screening for Lysosomal Storage Disorders, newborn screening timeliness, pilot studies for future nominated conditions, the National Contingency Plan for Newborn Screening, and working group updates
Read MoreOCT 13 VRBPAC
Strains to be included in an influenza virus vaccine for the 2017 southern hemisphere influenza season
Read MoreJUL 19 DODAC
Valeant’s brodalumab for plaque psoriasis
Read MoreJUL 13 AAC
Sandoz’ Biosimilar to Amgen’s ENBREL (etanercept) for rheumatoid arthrisis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis
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JUN 23 PCAC
Review of 6 substances nominated for inclusion on the section 503A bulk drug substances list. Updates on discussions from previous meetings, including the option for expanded access.
Read MoreJUN 20 BPAC
Research programs in CBER's Laboratory of Plasma Derivatives
Read MoreJUN 28 EMDAC
Boehringer Ingelheim Pharmaceuticals and Eli Lilly's JARDIANCE and SYNJARDY proposed new indication to reduce CV risk
Read MoreMAY 3-4 DSRM/AADPAC
Does the REMS with ETASU for ER/LA opioids assure safe use?
Is it not unduly burdensome to patient access to the drugs?
To the extent practicable, does it minimize the burden to the healthcare delivery system?
Read MoreAPR 25 PCNS
Sarepta's eteplirsen for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable to exon 51 skipping
Read MoreSEP 15-16 AADPAC, PEDAC, DSRM
Development plans for establishing the safety and efficacy of prescription opioid analgesics for pediatric patients, including obtaining pharmacokinetic data and the use of extrapolation
Read MoreAPR 12 PEDAC
Pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act
Information on the 2-day joint meeting of the Pediatric Advisory Committee, the Anesthetic and Analgesic Drug Products Advisory Committee, and the Drug Safety and Risk Management Advisory Committees on September 15 and 16, 2016.
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