Impact of labeling under the Pregnancy and Lactation Labeling Rule
Read MoreFEB 14 AADPAC
sNDA for EXPAREL (bupivacaine liposomal injectable suspension) by Pacira Pharmaceuticals, Inc., to produce local analgesia and as a nerve block to produce regional analgesia
Read MoreFEB 14 AADPAC-DSRM
HYDEXOR (hydrocodone, acetaminophen, and promethazine) by Charleston Laboratories
Read MoreMAR 23 PEDAC
Safety reviews required by BPCA/PREA
Read MoreJAN 11 AMDAC
Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreNov 30 - Dec 1 BPAC
Bacterial risk control strategies for transfusion, device classification of human leukocyte antigen, human platelet antigen, and human neutrophil antigen devices, strategies to reduce the risk of transfusion-transmitted Zika virus, information on the Transfusion Transmissible Infections Monitoring System, and information on the FDA public workshop on emerging tick-borne diseases and blood safety
Read MoreNOV 20-21 PCAC
Nominated Bulk Substances for Compounding, Nominated Products for the Demonstrably Difficult to Compound List
Read MoreOCT 12 CTGTAC
Voretigene neparvovec by Spark Therapeutics for the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy
Read MoreDEC 7 BRUDAC
Trial designs for drugs to treat interstitial cystitis and bladder pain syndrome
Read MoreAUG 3 AAC
sNDAs for XELJANZ (tofacitinib) and XELJANZ XR (tofacitinib) by Pfizer for the treatment of adult patients with active psoriatic arthritis
Read MoreJUL 26 AADPAC-DSRM
Intellipharmaceutics Corp.'s, oxycodone hydrochloride extended-release oral tablets
Read MoreJUN 21-22 ODAC
Potential pediatric development plans/written requests for: (1) APX-005M, presentation by Apexigen, Inc.; (2) PMO1183 (lurbinectedin), presentation by PharmaMar USA Inc.; (3) ASP2215 (gilteritinib), presentation by Astellas Pharma Global Development, Inc. (4) Prexasertib, presentation by Dista Products/Eli Lilly and Company; and (5) Olaratumab, presentation by Eli Lilly and Company.
Read MoreJUN 20 EMDAC
Novo Nordisk VICTOZA (liraglutide) for the proposed additional indication as an adjunct to standard treatment of cardiovascular risk factors
Read MoreMAY 18 PEDAC
Referral by an Institutional Review Board (IRB) of Sarepta's clinical investigation, entitled “A Double-Blind, Placebo-Controlled, 5 Multi-Center Study with an Open-Label Extension to Evaluate the Efficacy and Safety of SRP- 4045 and SRP-4053 in Patients with Duchenne Muscular Dystrophy.”
Read MoreMAY 25 ODAC
Proposed biosimilar to Amgen Inc.ʼs Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company
Read MoreMay 24 ODAC
1) Puma Biotechnology’s neratinib for HER2 breast cancer 2) Emmaus Medical, Inc’s glutamine solution for sickle cell disease
Read MoreMAY 8-9 PCAC
Review of substances nominated for the list of bulk substances allowed for compounding and products nominated for the difficult to compound list
Read MoreJUL 28 AAPAC-DSRM
Dynavax Technologies Corporation's HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)]
Read MoreMAR 29 ODAC
1) rituximab/hyaluronidase injection for subcutaneous use, submitted by Genentech, Inc. 2) binimetinib, submitted by Array BioPharma Inc (Topic 2 has since been cancelled.)
Read MoreAPR 4 NDAC-DSRM
1) Safety issues with OTC analgesics for upset stomach; and 2) Hangover indications under several monographs.
Read More