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Are You Not Interchanged? FDA's Recent Biosimilar Labeling Guidance Chips Away at Interchangeable Product Advantages. | Foley Hoag LLP

Interchangeable biosimilar products would not be allowed to disclose or explain their interchangeability designations in their products’ labels under FDA’s new draft guidance. . ....

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THE ACCREDITATION COUNCIL FOR MEDICAL AFFAIRS (ACMA) DEVELOPS FIRST EVER BOARD-CERTIFIED BIOLOGICS & BIOSIMILARS SPECIALIST (BCBBS) CERTIFICATION

/PRNewswire/ The Accreditation Council for Medical Affairs (ACMA) is launching a new Board Certification program focused on biologics and biosimilars. This. ....

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"Purple Book" Patent Listing Under Biological Product Patent Transparency Act: What is Required, and What to Expect? | King & Spalding

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 lists that reference product sponsors (
i.e., biologics innovators) are already required to exchange with biosimilar applicants ....

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Recent Amendments to the FDA Laws Attempt to Clarify and Improve Existing Systems | Mintz - Health Care Viewpoints

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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 readers are up to speed on the large amount of activity that occurred in the final weeks of the 116th Congress and the Trump Administration. ....

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Amendments to the FDA Laws try to Clarify and Improve Systems

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 occurred in the final weeks of the 116th Congress and the Trump Administration. ....

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