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 20, 2023

Biosimilar product developers are expected to conduct foundational analytical studies, animal studies, clinical pharmacology and immunogenicity assessments, and additional clinical evaluations to demonstrate biosimilarity or interchangeability. Developing biosimilars is an extensive and expensive process.

Science 40

Science Biosimilars FDA Production 40

Eye on FDA

AUGUST 4, 2021

The blue represents the number of AdComms, Orange the number of new molecular entities and the gray the number of BT designations (Note that 2021 figures are through June 30): What we can see here is that there is a significant body growing of BT designated compounds and a growing number, generally speaking, of new molecular entities being approved.

FDA 122

FDA Clinical Pharmacology FDA Approval Therapies 122

Agency IQ

OCTOBER 6, 2023

There were 21 NMEs added to the FDA’s Purple Book , which provides information about all biological products licensed by the FDA. This is a significant jump from any previous year, with the former peak at 15 in FY 2018, followed by several years in the 10-14 range. of all NME approvals this year.

FDA 52

FDA Biosimilars Science Production 52

The Pharma Data

FEBRUARY 8, 2021

Food and Drug Administration (FDA) approval for nmCRPC on February 14, 2018 and was approved for mCSPC on September 17, 2019. FDA on April 28, 2011 and by the European Commission on September 7, 2011. FDA on February 8, 2018. [vi] vi] Since its first approval in the U.S.

Pharmaceutical Companies 52

Pharmaceutical Companies Treatment Clinical Trials Trials 52