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FDA Issues Guidance on Biosimilar Labeling

Pharmaceutical Commerce

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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FDA Issues Guidance on Biosimilar Labeling

PharmaTech

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.

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Skinny Label and Induced Infringement: The Saga Continues

FDA Law Blog: Biosimilars

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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FDA Updates Draft Guidance on Promotional Communications of Prescription Biologics and Biosimilars

Big Molecule Watch

The updated guidance includes information on the general requirements for the content of FDA-regulated promotional communications about reference or biosimilar products and provides some examples to illustrate the FDA’s current recommendations for addressing reference, biosimilar, and interchangeable biosimilar products in product promotion.

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EU pharmaceutical legislation revisions: what are the implications for biopharma?

European Pharmaceutical Review

Changes to regulatory data protection periods are of particular interest to biopharma” Changes to regulatory data protection (RDP) periods are of particular interest to biopharma (originators and generic / biosimilar manufacturers). analysis (Source: L.E.K) What are the latest amendments?

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It’s the Law Now –Cybersecurity Information in Premarket Submissions

FDA Law Blog: Biosimilars

The primary vehicle for FDA to request cybersecurity information in premarket submissions has been guidance documents. Through a recent (and very short) Guidance document, FDA indicated that, starting on October 1, 2023, FDA may base “refuse to accept” (RTA) decisions on the information required by section 524B. Loose Ends IDEs.

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FDA Issues Long-Awaited QMSR Final Rule

FDA Law Blog: Biosimilars

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”