May 20, 2019

Vol. 16 No. 96

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Final Guidance Seeks to Speed Interchangeable Biosimilars to Market

The Association for Accessible Medicines said it “applauds” the final guidance document, “particularly its streamlined data and study design requirements… Read More

FDA Offers Advice on When to File and ANDA or 505(b)(2) Application

The FDA is willing to be flexible because the regulations outlining the content of an ANDA “do not describe the type or amount of information that an ANDA applicant must submit to demonstrate” that the active ingredient in the proposed generic drug product is the same as the active ingredient in the reference drug. Read More

Sunovion Earns Breakthrough Designation for Schizophrenia Treatment

In Phase 2 studies, patients treated with SEP-363856 showed statistically significant improvement.  Read More

Europeans Give Nod to Waylivra as Diet Adjunct

Akcea received a complete response letter from the FDA last year, citing concerns about the drug causing dangerous dips in patients’ platelet counts. Read More

FDA Offers Advice for Topical OTCs

The agency says it will work hard to keep the minutes confined to “a summary of general concepts that were discussed, while excluding information” that might reveal a company’s important secrets. Read More