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The European Medicines Agency is tightening stability testing requirements for drugmakers submitting applications for significant post-approval manufacturing changes that involve active substances. Read More
The European Commission is mandating that drugmakers implement a detailed protocol for transferring testing methodology from one lab to another to ensure product quality. Read More
The European Medicines Agency is looking into potential heart risks linked to testosterone-containing drugs after an EU member state regulator raised safety concerns. Read More
Drugmakers and distributors are asking the FDA to delay strict enforcement of federal track-and-trace requirements, since most companies won’t be able to meet the first deadlines for exchanging transaction data. Read More
U.S. lawmakers are asking the Office of the United States Trade Representative to put Canada back on its priority watch list after the country withdrew a number of patents for drugs sold by American drugmakers. Read More
An FDA task force Tuesday recommended the agency expand the amount of information about inspections and enforcement that it releases, allowing the public to view a more detailed record of a company’s compliance history. Read More
The UK’s Health Research Authority is helping drugmakers do a better job justifying their trial designs and protocol assumptions early on to avoid trial failures due to insufficient information. Read More
Emergent BioSolutions has received an orphan drug designation for an expanded indication for BioThrax, its anthrax vaccine already in wide use by the U.S. military. Read More