The company based in Lexington County received its inspection report back from federal regulators. Here’s what it showed.
The agency’s decision to conceal drug names on inspection reports has prevented doctors, pharmacists and patients from ...
FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed ...
The U.S. Food & Drug Administration has confirmed that the multistate outbreak of Listeriosis linked to refrigerated and ...
Jordan, represented by the Jordan Food and Drug Administration (JFDA), has been granted full membership in the Pharmaceutical Inspection Co-operation Scheme (PIC/S), becoming the second Arab nation to ...
This recall affects America’s most prescribed drug. It’s the latest in a series of concerning manufacturing issues that have ...
Alvotech rated Hold after FDA setback for AVT05. Click for my look at ALVO stock prospects and what would make me upgrade it ...
Executives from Eli Lilly, Merck and other companies foresee the FDA's new onshoring proposal being anything from a ...
The FDA has slammed generic drug maker Hetero Labs with a Form 483 after an inspection of one of its warehouses in India ...