Business · 13/03/1998

FDA Guidance on Implementation of FDAMA Section 126

The Food and Drug Administration (FDA) has released a guidance document outlining the implementation of the Food and Drug Administration Modernization Act of 1997 (FDAMA), which amended the Federal Food, Drug, and Cosmetic Act to require prescription-only labeling for certain products. The guidance clarifies FDA policy on the elimination of certain labeling requirements, which took effect on February 19, 1998.