The US Food and Drug Administration (FDA) was busy in 2023 with significant, and even bullish, developments occurring across several areas, from drug and biologic development and manufacturing to labeling, advertising, and...more
The Purple Book—a database containing information about all licensed biological products—is set for a revamping that offers more patent transparency regarding reference biologics. The Purple Book, which was first published in...more
From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more
7/1/2020
/ Biologics ,
Biosimilars ,
CGMP ,
Clinical Trials ,
Coronavirus/COVID-19 ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Life Sciences ,
National Institute of Health (NIH) ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Research and Development
The US Food and Drug Administration (FDA) issued an updated draft guidance on March 7 on the nonproprietary naming of biologics, titled Nonproprietary Naming of Biological Products: Update (Guidance). This update is FDA’s...more
The draft language reauthorizes FDA’s authority to assess user fees and proposes fee restructuring and increases.
On April 14, the health committees for both the US Senate and the US House of Representatives released a...more