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The FDA doesn’t have explicit penalties for failing to self-identify as a generic facility, but noncompliance can raise the likelihood of a pre-approval inspection, the agency said in a guidance document. Read More
Diabetes drugs carry special development challenges and can be the riskiest sector in pharmaceuticals, with one in 13 investigational drugs achieving U.S. approval, according to a report from the Tufts Center for the Study of Drug Development. Read More
The FDA will decide whether to require a Risk Mitigation and Evaluation Strategy after weighing known and potential adverse events, the seriousness of the condition, and the drug’s expected benefits, according to a draft guidance to industry. Read More
The U.S. Court of Appeals for the Federal Circuit affirmed the validity of Abbott’s protein-binding patent, handing yet another victory to the company in a decades-long dispute with Yeda Research and Development. Read More
California Gov. Jerry Brown (D) signed into law a bill that would allow companies, nonprofits and government agencies to purchase and maintain Mylan’s EpiPen for emergency use, while criticizing the company for the hiking the price of the allergy treatment. Read More
If Mylan wants to improve access to its emergency allergy treatment EpiPen, then the company should lower the price of the drug, instead of marketing a generic version, members of the House Committee on Oversight and Government Reform said Wednesday. Read More