RAPS

FDA updates guidance on promotional labeling and advertising of biosimilars

The US Food and Drug Administration (FDA) has published revised guidance on promotional labeling and advertising for prescription biosimilar drugs and their reference products. The agency issued the ...
JD Supra

Food and Drug Administration Issues Product Labeling, Advertising Draft Guidance for Prescription Biological Reference and Biosimilar Products

The Food and Drug Administration’s (FDA) recent draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products – Questions and ...
RAPS

FDA finalizes guidance on biologic, biosimilar promotional labeling

The US Food and Drug Administration (FDA) has finalized guidance on promotional labeling and advertising for prescription biosimilars, interchangeable biosimilar products, and their reference listed ...
JD Supra

FDA’s Draft Guidance on Promotional Labeling and Advertising Considerations

Earlier this week FDA issued a draft guidance on “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products.” The draft guidance addresses the ...
MM&M

FDA clarifies biosimilar labeling, advertising guidelines

The Food and Drug Administration and Federal Trade Commission have drawn a line on anticompetitive practices in the complex biosimilar market. The agencies have announced their intent to enforce false ...
Drug Store News

Biosimilars Council submits comments to FDA for promotional labeling, advertising considerations

On behalf of its members, the Biosimilars Council has submitted comments to the Food and Drug Administration on draft guidance that discusses considerations for presenting data and information about ...