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
Read MoreOCT 31 PDAC-DSRM
Buprenorphine subcutaneous injection, submitted by Indivior 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
Read MoreOCT 18 EMDAC
Novo Nordisk’s Semaglutide for Type 2 Diabetes
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 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 MoreOCT 18 EMDAC
Novo Nordisk’s Semaglutide for Type 2 Diabetes
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 MoreOCT 17-18 SACHRP
Topics related to human research protections
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 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 MoreOCT 13 DODAC
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 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 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
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