Regulatory Overview: Post-Approval Changes to Marketed Drugs – The popularity of GLP-1s have brought post-approval changes to New Drug Applications (NDAs) to centerstage. Recently, the FDA approved Wegovy in tablet form, offering an alternative to the injection currently on the market. Whether relating to drug labeling, dosage form or containers, each change to an NDA must be reported to the FDA….
By: Haynes Boone
By: Haynes Boone
