The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time ...
Senators this week introduced a bipartisian bill that would update the Food and Drug Administration’s process for inspecting medical devices. The bill — sponsored by Sens. Michael Bennet, D-Colo., and ...
Industry and FDA representatives have reached a general agreement on planned pre-submission facility meetings but have expressed different views about the specifics.
While the authors are not huge fans of the rock band Def Leppard, its 1983 “Photograph” hit came to mind recently, when we read a recent Warning Letter issued, in part, because of a company’s refusal ...
Add Yahoo as a preferred source to see more of our stories on Google. Despite multiple warnings from the Food and Drug Administration about its manufacturing processes, Nephron Pharmaceuticals, one of ...
This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. WASHINGTON (AP) — For the second time in ...
An FDA investigator prepares a test sample for IMS analysis from a shipment of dietary supplements that arrived at the Port of Buffalo in Buffalo, N.Y. (FDA photo) The outbreak of COVID-19 has called ...
When Health and Human Services Secretary Robert F. Kennedy Jr. announced in March that he would eliminate thousands of jobs from federal health agencies, he promised that he would spare the inspectors ...