Industry and FDA representatives have reached a general agreement on planned pre-submission facility meetings but have expressed different views about the specifics.

“Our customers, in partnership with federal and state agencies, are reshoring drug manufacturing in the U.S., the world’s largest pharmaceutical market. Local API production is vital for supply chain ...

A Wood County grand jury on March 4 also indicted Chad Michael Oswald, 32, currently in jail, for illegal manufacturing of drugs, a first-degree felony, for allegedly mixing and preparing crack ...

Major drugmakers Roche, AstraZeneca, and Johnson & Johnson plan to invest billions to expand drug manufacturing in the United States.

Scientists at the University of Cambridge have developed a new way to alter complex drug molecules using light rather than toxic chemicals—a discovery that could accelerate and improve how medicines ...

On March 11, the FDA launched a unified platform for analyzing adverse event reports, replacing a fragmented infrastructure that had long-impeded effective postmarket surveillance.¹ Known as the FDA ...

Add Yahoo as a preferred source to see more of our stories on Google. Several batches of the drug did not dissolve properly, which means the person taking them would receive a lower dose.

This article explores current OSD development and manufacturing trends from a CDMO perspective, including the evolution of ...

President Donald Trump unveiled “most favored nation” drug agreements with nine manufacturers on Friday, with senior administration officials claiming that pharmaceutical companies are now rushing to ...

In the opening remarks, Michael Kopcha, Director of the Office of Pharmaceutical Quality (OPQ), offered CDER’s perspective on advanced manufacturing and pharmaceutical quality. He began the ...