Over the past week, the FDA issued final guidance on revising ANDA labeling, draft guidances on metallic coatings and/or calcium phosphate coatings on orthopedic devices and conducting remote regulatory assessments.…
The FDA is offering drugmakers the opportunity to become involved in an agency effort to find ways to evaluate quality management maturity (QMM) by using a prototype assessment protocol. Source:…
Listen to FDA Drug Safety Podcast, FDA's preliminary evaluation has not found evidence that use of GLP-1 RAs causes suicidal thoughts/actions. Source: FDA Drug Safety Podcasts
While secondary T-cell cancers following CAR-T cell therapy are relatively rare adverse events, the FDA wants its new boxed warning labeling changes for the drugs to encourage more data on…
The Department of Justice (DOJ) and HHS issued a joint letter to state Medicaid administrators urging them to act in accordance with the Americans with Disabilities Act (ADA) and allow…
The Biden administration and Danco Laboratories, manufacturer of the abortion pill mifepristone, have filed briefs petitioning the Supreme Court to keep wider patient access because restricting the drug would have…
An Illinois law that targets “price gouging” for generic drugs is the target of a lawsuit filed by the trade group representing America’s generics and biosimilar manufacturers who claim the…
The Canadian government is not happy with the FDA’s decision to allow the state of Florida to import certain Canadian prescription drugs in bulk, and neither is the powerful U.S.…
Two significant changes in the FDA’s final guidance on updating ANDA labeling are details on how to obtain information on changes to reference listed drug (RLD) labeling and how to…
Novo Nordisk, seeking to remain in the front of the weight loss drug race, has inked a deal with EraCal Therapeutics, a biotech startup, whose small molecule program offers a…