Buprenorphine sublingual spray, by INSYS Development Company, for the treatment of moderate-to-severe acute pain where the use of an opioid analgesic is appropriate
Read MoreMAY 3 GIDAC-PEDAC
Atannsoporfin intramuscular injection, by InfaCare Pharmaceutical Corp, for neonates ≥ 35 weeks of gestational age with indicators of hemolysis who are at risk of developing severe hyperbilirubinemia
Read MoreMAY 2 AMDAC
Plazomicin, by Achaogen,Inc., for the proposed indications for the treatment of complicated urinary tract infections and blood stream infections
Read MoreAPR 10-11 CLIAC
Updates from the CDC, CMC and FDA. Presentations and discussion on other topics of interest to clinical laboratories.
Read MoreAPR 23 AAC
Baricitinib tablets, submitted by Eli Lilly and Company, proposed for the treatment of adult patients with moderately 5 to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate
Read MoreAPR 19 PCNS
Cannabidiol oral solution, sponsored by GW Pharmaceuticals, proposed for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older
Read MoreMAR 27 PDAC
Lofexidine hydrochloride, submitted by US WorldMeds, LLC, for mitigation of symptoms associated with opioid withdrawal and facilitation of completion of opioid discontinuation treatment
Read MoreMAY 10 EMDAC
Volanesorsen solution for subcutaneous injection, submitted by Akcea Therapeutics, Inc., proposed as an adjunct to diet for the treatment of patients with familial chylomicronemia syndrome.
Read MoreMAR 7 ODAC
Supplemental biologic license application for BLINCYTO (blinatumomab) injection, submitted by Amgen, Inc., proposed for the treatment of minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia.
Read MoreMAR 21-22 BPAC
Reclassification of certain Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) diagnostics. Presentations about research programs at the FDA's Center for Biologics Evaluation and Research (CBER).
Read MoreMAR 1 VRBPAC
1) Recommendations on the selection of strains to be included in the influenza virus vaccines for the 2018-2019 U.S. influenza season 2) Overview of the research program in the Laboratory of Mucosal Pathogens and Cellular Immunology (LMPCI), Division of Bacterial, Parasitic and Allergenic Products (DBPAP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER), FDA
Read MoreFEB 8 ACHDNC
Issues related to newborn screening (NBS) and the diagnosis and treatment of individuals with heritable disorders
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 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 More