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The House Committee on Energy and Commerce is examining the FDA’s Office of Criminal Investigations (OCI) over a variety of case management concerns. Read More
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
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known and potential adverse events, the seriousness of the condition, and the drug’s expected benefits, according to a draft guidance to industry.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
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
Several senators expressed doubts that the FDA should take on the regulation of tens of thousands of laboratory-developed tests currently being used across the country, during a committee hearing on the future of regulation in an age of precision medicine. Read More
The FDA hopes to refine the review process and fee structure for biosimilar products in the next iteration of the Biosimilar User Fee Act to improve efficiency and resource availability. Read More