HYDEXOR (hydrocodone, acetaminophen, and promethazine) by Charleston Laboratories
Read MoreMAR 23 PEDAC
Safety reviews required by BPCA/PREA
Read MoreDEC 7 BRUDAC
Trial designs for drugs to treat interstitial cystitis and bladder pain syndrome
Read MoreJAN 11 AMDAC
Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreDEC 7 BRUDAC
Trial designs for drugs to treat interstitial cystitis and bladder pain syndrome
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 MoreJAN 11 AMDAC
Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreJAN 9 BRUDAC
Oral testosterone undecanoate capsules, submitted by Clarus Therapeutics, Inc.
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 MoreJAN 10 BRUDAC
Oral testosterone undecanoate capsules by Lipocine Inc.
Read MoreNOV 20-21 PCAC
Nominated Bulk Substances for Compounding, Nominated Products for the Demonstrably Difficult to Compound List
Read MoreNOV 16 AMDAC
Ciprofloxacin inhalation powder by Bayer
Read MoreNOV 16 AMDAC
Ciprofloxacin inhalation powder by Bayer
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 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 7 VRBPAC
Recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations
Read MoreNOV 7 VRBPAC
Recommendations on the clinical development plan for Pfizer’s investigational Staphylococcus aureus vaccine intended for pre-surgical prophylaxis in elective orthopedic surgical populations
Read MoreNOV 1 PDAC-DSRM
Buprenorphine subcutaneous injection, submitted by Breaburn Pharmaceuticals, Inc., for treatment of opioid dependence
Read MoreNOV 20-21 PCAC
Nominated Bulk Substances for Compounding, Nominated Products for the Demonstrably Difficult to Compound List, And More
Read MoreOCT 31 PDAC-DSRM
Buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence
Read More