We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Earlier this summer the FDA recommended a five-point scale to rate topical patch adhesion for drugmakers submitting abbreviated new drug applications (ANDA). However, the recommendations have only raised more questions. 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