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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