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By Marla Scarola In March 2015, FDA announced a revision to its formal meetings guidance with the release of the Draft Guidance to Industry: Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User...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

Tobacco Final Rule: Advice for Manufacturers

By Zachary Mietus On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including e-cigarettes, gels, and e-vapor among others. As... Read More