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 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
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 More