JD Supra

FDA ends interchangeability statement requirement for biosimilar labels

The U.S. Food and Drug Administration (FDA) recently issued new revised draft guidance on “Labeling for Biosimilar and Interchangeable Biosimilar Products,” which most notably dispenses with any ...
JD Supra

New FDA Guidance Removes Interchangeability Statement from Product Labels

On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” ...
Healio

Q&A: How to ‘improve’ an FDA label with evidence, advocacy

Health care professionals can have a powerful impact on labeling requirements for drugs by formally petitioning the FDA for ...
Medscape

Introduction to the New Prescription Drug Labeling by the Food and Drug Administration

A label begins with highlights, a succinct, half-page summary of the information that health care practitioners most commonly refer to and view as most important (Figure 2). [4] This section provides ...