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HHS Transparency, Fairness Rule

[ Price : $8.95]

HHS issues an additional final rule amplifying an earlier good guidance practices rule.

Info Collection Extension for Extralabel Drug Use

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Federal Register notice: FDA sends to OMB an information collection extension for Extralabel Drug Use for Animals 21 CFR 530.

SCOTUS Backs FDA Mifepristone Requirement

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Splitting along ideological lines, the Supreme Court says FDA can enforce a requirement that women seeking a medication abortion m...

FDA Artificial Intelligence Action Plan Outlined

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Two SheppardMullin attorneys outline the contents of an FDA action plan for artificial intelligence/machine learning.

STeP Requests Start 3/8: Report

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Two Hogan Lovells attorneys describe provisions in an FDA final guidance on the voluntary STeP program for medical devices.

Generic Zantac Suit Falls to Preemption

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A Florida federal court throws out multidistrict litigation against manufacturers and distributors of generic Zantac.

Harpoon Therapeutics Orphan Status for Myeloma Drug

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FDA grants Harpoon Therapeutics an orphan drug designation for HPN217 for treating multiple myeloma.

AI/ML Medical Device Action Plan

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The FDA Digital Health Center of Excellence issues an action plan for artificial intelligence and machine learning software as a m...

Info Collection on Device 513(g) Info Requests

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Federal Register notice: FDA seeks comments on an information collection extension entitled 513(g) Request for Information.

Federal Register Notice on Export Certificates Correction

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Federal Register notice: FDA corrects a 12/21/2020 Federal Register notice seeking comments on an information collection extension...