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Medical Devices Pharmaceutical Industry Government Accountability Office

Goodwin

Congress Expands Pathway for Drug & Device Manufacturers’ Pre-Approval Communication of Health Care Economic Information to...

Goodwin on

The legislation previously introduced as the Pre-Approval Information Exchange Act of 2022 ( “PIE Act”) was passed as part of Congress’s December 23, 2022 omnibus spending bill. Once signed into law, this legislation will...more

Akin Gump Strauss Hauer & Feld LLP

FDA Changes Direction in Final CDS Guidance

FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more

McGuireWoods Consulting

Washington Healthcare Update - June 2021 #1

Congress - House and Senate are in recess for two weeks. Senate - Brooks-LaSure Confirmed as CMS Administrator - On May 25, the Senate voted 55-44 to confirm Chiquita Brooks-LaSure as the Centers for Medicare...more

Alston & Bird

FDA Issues New Guidance on Remote Interactive Evaluations for Oversight of Drug Facilities

Alston & Bird on

Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s first guidance on remote interactive evaluations, a tool in response to the agency’s COVID-19 inspection postponements....more

Alston & Bird

Alston & Bird Healthcare Week in Review

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Below is Alston & Bird’s Healthcare Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies, and...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - August 2017

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

McGuireWoods LLP

Washington Healthcare Update

McGuireWoods LLP on

This Week: FDA Begins Device User Fee Talks with Patients and Consumers Sept. 15... CMS Extends Partial Enforcement Delay of Two-Midnight Policy Through 2015... Alaska Legislature Sues Governor Over Medicaid Expansion....more

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