1) use of prescription opioid products containing hydrocodone or codeine for the treatment of cough in pediatric patients 2) Pediatric-focused safety reviews, as mandated by BPCA/PREA/PMDSIA
Read MoreSEP 14 AADPAC-DSRM
Review of pediatric study of Butrans (buprenorphine transdermal) by Purdue Pharma L.P. for management of pain
Read MoreSEP 19 ODAC
sNDA for SUTENT (sunitinib malate), represented by Pfizer, Inc. (authorized U.S. agent), proposed for the adjuvant treatment of adult patients at high risk of recurrent renal cell carcinoma following nephrectomy.
Read MoreSEP 13 VRBPAC
Zoster Vaccine Recombinant, Adjuvanted, manufactured by GlaxoSmithKline Biologicals
Read MoreSep 8 MIDAC
Gadolinium retention in the brain and other body organs in patients receiving gadolinium-based contrast agents for magnetic resonance clinical imaging procedures
Read MoreAUG 3-4 ACHDNC
Heritable Disorders in Newborns and Children
Read MoreJUL 25-26 SACHRP
Topics related to human research protections
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 MoreAUG 2 AAC
Janssen's sirukumab injection (proposed trade name PLIVENSIA) for certain patients with rheumatoid arthritis
Read MoreJUN 26 SBFDA
1) FDA's biotechnology activities related to plant-derived food and animals
2) Report from the National Antibiotic Resistance Monitoring System Review Subcommittee
Read MoreJUL 12 ODAC
Tisagenlecleucel-T suspension by Novartis Pharmaceuticals Corp. for the treatment of pediatric and young adult patients 3 to 25 years of age with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)
Read MoreJUL 11 ODAC
Mylotarg (gemtuzumab ozogamicin) by Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc. for use is in combination therapy with daunorubicin (DNR) and cytarabine (AraC) for the treatment of adult patients with previously untreated, de novo acute myeloid leukemia (AML)
Read MoreJUL 13 ODAC
Morning session: proposed biosimilar to Genentech/Roche’s AVASTIN (bevacizumab), submitted by Amgen Inc. Afternoon session: a proposed biosimilar to Genentech Inc.’s HERCEPTIN (trastuzumab), submitted by Mylan GmbH.
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 MoreJUL 28 VRBPAC
HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)] by Dynavax Technologies Corp.
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 17 VRBPAC
Considerations for evaluation of Respiratory Syncytial Virus vaccines in seronegative infants
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 9 SBFDA
Recommendations on the Agency’s Innovation Funds work plan as prescribed in section 1002 of the 21st Century Cures Act
Read More