Proposed biosimilar to Amgen Inc.ʼs Epogen/Procrit (epoetin alfa), submitted by Hospira Inc., a Pfizer company
Read MoreMAY 11-12 ACHDNC
Topics Related to Newborn Screening and Medical Foods
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 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 MoreMay 25-26 SACHRP
1) Common Rule 2) Real-world evidence for devices
Read MoreMAY 10 MIDAC
5-Aminolevulinic Acid Hydrochloride [5-ALA HCl], Powder, for oral solution, submitted by NX Development Corp., for the proposed indication as an imaging agent to facilitate the real time detection and visualization of malignant tissue during glioma surgery.
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 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 MoreAPR 13 AMDAC
Development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections
Read MoreAPR 13 AMDAC
Development of antibacterial drugs that treat a single species of bacteria when the target species infrequently causes infections
Read MoreAPR 5 AADPAC-DSRM
Proposed abuse-deterrent oxycodone immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC
Read MoreAPR 4-5 BPAC
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 MoreAPR 4 NDAC-DSRM
1) Safety issues with OTC analgesics for upset stomach; and 2) Hangover indications under several monographs.
Read MoreAPR 5 AADPAC-DSRM
Proposed abuse-deterrent oxycodone immediate-release oral tablets, submitted by Inspirion Delivery Sciences, LLC
Read MoreJUL 28 AAPAC-DSRM
Dynavax Technologies Corporation's HEPLISAV-B™ [Hepatitis B Vaccine, Recombinant (Adjuvanted)]
Read MoreAPR 4-5 BPAC
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 MoreAPR 4 NDAC-DSRM
1) Safety issues with OTC analgesics for upset stomach; and 2) Hangover indications under several monographs.
Read More