Agency IQ

SEPTEMBER 15, 2023

Until recently, the FDA relied on a monograph process through which firms could bring OTC drugs to market without FDA approval so long as it adhered to pre-set terms under the monograph. FDA’s cough cold monograph only designates two oral products as GRASE – phenylephrine and pseudoephedrine.

Science 40

Science FDA Clinical Trials Pharmacy 40

Agency IQ

OCTOBER 6, 2023

Taking a closer look, nearly half of the products were reviewed by the Office of Oncologic Diseases. The largest portion of reviews after that were 14% (3 NMEs) each with the Office of Neuroscience and the Office of Rare Diseases, Pediatrics, Urologic and Reproductive Medicine. of all NME approvals this year.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

FEBRUARY 8, 2021

ACIS is a Phase 3 randomized, double-blind, placebo-controlled, multicenter clinical study evaluating the efficacy and safety of ERLEADA ® and ZYTIGA ® plus prednisone compared to placebo and ZYTIGA ® plus prednisone in 982 patients with chemotherapy-naïve mCRPC disease who received ADT. FDA on February 8, 2018. [vi]

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Trials 52