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Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance. ...
/PRNewswire/ -- The Accreditation Council for Medical Affairs (ACMA) is launching a new Board Certification program focused on biologics and biosimilars. This...
The Biological Product Patent Transparency Act (“BPPT”) 1 – tucked into Congress’s omnibus spending bill (“Consolidated Appropriations Act,” H.R. 133, Pub. L. No. 116-260) signed into law on December 27, 2020 – is the first-ever provision requiring public listing in the FDA’s “Purple Book” of certain patents associated with biologic drug products ( e.g., monoclonal antibody products and other protein drug products). See the text of the BPPT here. The BPPT sidestepped some of the more controversial approaches to biologics patent listing, by piggybacking off of the patent li...
To embed, copy and paste the code into your website or blog: Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings (as reported by our colleagues in this post), several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our...
Thursday, January 28, 2021 Although the Biden-Harris Administration that assumed control of the Executive Branch on January 20, 2021 immediately ordered a regulatory freeze of new or pending rules while the new administration gets its bearings, several important changes to the laws enforced by the Food and Drug Administration (FDA) were recently enacted by Congress. As legislative actions, those changes are of course unaffected by President Biden’s regulatory freeze and so we thought worth a summary to ensure our readers are up to speed on the large amount of activity that occurr...