News & Analysis as of

New Regulations Abbreviated New Drug Application (ANDA) Food and Drug Administration (FDA)

Orrick, Herrington & Sutcliffe LLP

FDA’s “Radical Transparency” Arrives: Real-Time Publication of CRLs Poses New Exposures for Innovative Pharmaceutical Companies

The U.S. Food and Drug Administration (FDA) has unveiled a sweeping transparency initiative that will fundamentally change how innovative drug and biologic developers interface with the Agency and the market. ...more

ArentFox Schiff

What Life Sciences Companies Need to Know in 2025

ArentFox Schiff on

Key Insights for Pharma Manufacturers Regarding the AKS - In a series of recent legal challenges initiated by the pharmaceutical industry against the US Department of Health and Human Services Office of the Inspector General...more

ArentFox Schiff

FDA Finds Significant Bioequivalence Concerns in Raptim Studies Leading to ANDA and NDA Reviews

ArentFox Schiff on

In a highly unusual move, on March 27, the US Food and Drug Association (FDA) issued a Drug Safety Notice that calls into question both pending and approved abbreviated new drug applications (ANDAs) and new drug applications...more

3 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide