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Biotechnology Rulemaking Process Life Sciences

Bergeson & Campbell, P.C.

NSCEB Seeks Input to Modernize Biotechnology Product Regulation

The National Security Commission on Emerging Biotechnology (NSCEB) announced on July 1, 2025, that it is gathering input to modernize U.S. biotechnology product regulation and create simpler, faster, science-based pathways to...more

Hogan Lovells

A bit more Sunshine: CMS proposes collecting additional information on manufacturer payments under the Open Payments program

Hogan Lovells on

Device and drug manufacturers got a small surprise in the annual Physician Fee Schedule proposed rule (at 40,713-16) issued late in July by the Centers for Medicare & Medicaid Services (CMS) – among many other things, the...more

Hogan Lovells

FDA publishes final guidance on ANDA/505(b)(2) NDA pathways

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On Thursday, FDA published the final guidance document, “Determining Whether to Submit an ANDA or a 505(b)(2) Application” that contains minor revisions to the October 2017 draft guidance. ...more

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