Ciprofloxacin dispersion for inhalation by Aradigm Corp.
Read MoreJAN 10 BRUDAC
Oral testosterone undecanoate capsules by Lipocine Inc.
Read MoreJAN 9 BRUDAC
Oral testosterone undecanoate capsules by Clarus Therapeutics, Inc
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 MoreNOV 16 AMDAC
Ciprofloxacin inhalation powder by Bayer
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 20-21 PCAC
Nominated Bulk Substances for Compounding, Nominated Products for the Demonstrably Difficult to Compound List, And More
Read MoreNOV 1 PDAC-DSRM
Buprenorphine subcutaneous injection, submitted by Breaburn Pharmaceuticals, Inc., for treatment of opioid dependence
Read MoreOCT 31 PDAC-DSRM
Buprenorphine subcutaneous injection, submitted by Indivior Pharmaceuticals, Inc., for treatment of opioid dependence
Read MoreOCT 18 EMDAC
Novo Nordisk’s Semaglutide for Type 2 Diabetes
Read MoreOCT 13 CTGTAC
Rhopressa (netarsudil ophthalmic solution 0.02%) by Aerie Pharmaceuticals Inc., proposed to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
Read MoreOCT 12 CTGTAC
Voretigene neparvovec by Spark Therapeutics for the treatment of patients with vision loss due to confirmed biallelic RPE65 mutation-associated retinal dystrophy
Read MoreSEP 28 PCNS
Translarna (ataluren) by PTC Therapeutics for the treatment of patients with dystrophinopathy due to a nonsense mutation in the dystrophin gene
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 14 AADPAC-DSRM
Review of pediatric study of Butrans (buprenorphine transdermal) by Purdue Pharma L.P. for management of pain
Read MoreSEP 13 VRBPAC
Zoster Vaccine Recombinant, Adjuvanted, manufactured by GlaxoSmithKline Biologicals
Read MoreSEP 11-12 PEDAC
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 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 AAC
sNDAs for XELJANZ (tofacitinib) and XELJANZ XR (tofacitinib) by Pfizer for the treatment of adult patients with active psoriatic arthritis
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