The Drug Discovery Process Is Cumbersome. Amazon Wants to Fix It With AI

The process of discovering new drugs and bringing them to market is notoriously slow and inefficient. Amazon Web Services is ...
RAPS

New FDA Guidance Explains Process Behind Safety Labeling Changes for Drugs, Biologics

The US Food and Drug Administration (FDA) has released a new guidance document pertaining to labeling changes made to pharmaceutical and biological products based on new safety information discovered ...
The American Journal of Managed Care

FDA Will Require Only 1 Study to Approve New Drugs, Speeding Up Process

A commentary by FDA officials Vinay Prasad, MD, MPH, and Martin Makary, MD, MPH, details the new system for drug approvals in the US. FDA Commissioner Martin Makary, MD, MPH, and his top deputy Vinay ...
Regulatory Affairs Professionals Society

Asia-Pacific Roundup: Hong Kong starts phased shift to independent assessment of new drug submissions

Hong Kong’s Department of Health (DH) has begun a phased transition to the independent assessment of primary data on new drugs submitted for approval in the city.

Legal questions swirl around FDA's new expedited drug program, including who should sign off

The Food and Drug Administration commissioner's effort to drastically shorten the review of drugs favored by President Donald Trump's administration is causing alarm across the agency, stoking worries ...