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Alcon Pharmaceuticals is asking the FDA to apply stricter requirements on bioequivalence studies intended to supplement applications for Durezol and Ciprodex generics. Read More
A group of pharmaceutical companies has filed a joint amicus brief defending ex-Acclarent executives William Facteau and Patrick Fabian, urging a federal court to acquit them of misdemeanor charges. Read More
The Senate approved a bill extending the FDA’s program that offers priority review vouchers for rare pediatric disease treatments Sept. 22, one week before the program’s set expiration date. Read More
To shed light on the regulatory requirements for the development of co-crystals, the FDA is offering drugmakers submitting ANDAs and NDAs a clearer definition of co-crystals that no longer denotes them as an in-process material. Read More
The Senate is considering a bill that would prohibit the federal government from restricting the sale and use of experimental, unapproved drugs for fatal illnesses. Read More
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known and potential adverse events, the seriousness of the condition, and the drug’s expected benefits, according to a draft guidance to industry.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