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Federal officials on Wednesday filed to intervene in a whistleblower suit alleging that English drugmaker Mallinckrodt used a copay charity as a front for illegal kickbacks. Read More
Attorneys General who have painted the generics industry as an illegal price-fixing cabal should face their state employee health plans and demand they only pay for brand name drugs, the head of the largest generics lobbying group said Wednesday. Read More
Additionally, a reinstatement fee goes into effect on that date for sponsors who have allowed their GMP clearance to lapse beyond the 30-day limit. Read More
The Drug Enforcement Agency on Tuesday urged Congress to classify illicit fentanyl analogues as Schedule I drugs permanently, claiming they’re a significant danger to public health. Read More
The House Appropriations committee on Tuesday approved nearly $3.3 billion in spending for the FDA for fiscal year 2020 and once again nudged the agency to get going on its delayed continuous manufacturing initiative. Read More
The FDA took a victory lap after a federal judge agreed to shut down a pair of Florida stem cell clinics, but the agency made clear that it won’t rest on its laurels and is now focused on its ongoing contest with a Beverly Hills surgeon over unapproved stem cell therapies. Read More
Illinois-based compounder PharMedium Services has been ordered to shut down operations at its Tennessee site after repeated warnings from the FDA to clean up its act. Read More