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#8: Special Protocol Assessment

By Zachary Mietus The Food and Drug Administration (FDA) released a draft guidance on the Special Protocol Assessment (SPA) in May 2016, updating the original SPA guidance issued in 2002. SPAs are meant to give Sponsors and FDA a framework... Read More

#9: Changes to an Approved NDA or ANDA

By Kristen Booth On November 21, 1997, the Food & Drug Modernization Act (the Modernization Act) was enacted by Congress.  Section 116 of the Modernization Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to add section 506A.  This... Read More

Making a Case for Face-to-Face Meetings

By Marla Scarola In March 2015, FDA announced a revision to its formal meetings guidance with the release of the Draft Guidance to Industry: Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User... Read More