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The EMA is clarifying agency expectations on the implementation of risk-based models and exposure limits to prevent cross-contamination during manufacturing in a Q&A guideline, telling manufacturers that all products should have health-based exposure limits (HBEL). Read More
Unrestricted access to electronic records and a series of quality control deficiencies resulted in a seven-observation 483 for a specialty drugmaker based in Maryland. Read More
The FTC is asking a Georgia federal court to remove Par Pharmaceuticals and Paddock Laboratories from an antitrust case that alleges the companies delayed the market entry of their AndroGel generics in exchange for payments. Read More
The federal government issued a subpoena to Biogen requesting information on prices, rebates and co-assistance programs for four of its therapies, according to an SEC filing by the company. Read More
Advanced therapy medical products are facing several development hurdles, ranging from inadequate regulatory guidance to insufficient funding, the EMA said. Read More
The FDA will no longer redact the CVs of its advisory committee members, in response to a Freedom of Information Act lawsuit filed by Public Citizen last year. Read More