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 MoreJAN 11 AMDAC
Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreJAN 10 BRUDAC
Oral testosterone undecanoate capsules by Lipocine Inc.
Read MoreMAR 5-6 RCAC
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 MoreJAN 11 AMDAC
Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreJAN 9 BRUDAC
Oral testosterone undecanoate capsules, submitted by Clarus Therapeutics, Inc.
Read MoreJAN 10 BRUDAC
Oral testosterone undecanoate capsules by Lipocine Inc.
Read MoreJAN 9 BRUDAC
Oral testosterone undecanoate capsules by Clarus Therapeutics, Inc
Read MoreFEB 14 AADPAC-DSRM
HYDEXOR (hydrocodone, acetaminophen, and promethazine) by Charleston Laboratories
Read MoreMAR 23 PEDAC
Safety reviews required by BPCA/PREA
Read MoreFEB 14 AADPAC-DSRM
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 More