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Medical Devices › Administrative Procedure Act

Latham & Watkins LLP

New FDA Brief in Supreme Court Tobacco Case Puts Spotlight on Post-Chevron Regulatory Landscape

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FDA says its authority to implement the TCA is not limited by Loper Bright, but suggests that future guidance documents may be limited. On August 26, 2024, the US Food and Drug Administration (FDA or the Agency) filed its...more

Irwin IP LLP

Will Third Party Servicers Lose Their Right to Repair Medical Devices Under the APA’s Judicial Review?

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Med. Imaging & Tech. All. v. Libr. Of Cong., No. 23-5067, 2024 WL 2873107 (D.C. Cir. June 7, 2024) - In October of 2021, pursuant to the triennial review process of the Digital Millennium Copyright Act (“DCMA”), the...more

Manatt, Phelps & Phillips, LLP

Laboratory Association Sues FDA Over its Recent Laboratory-Developed Test Final Rule

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On May 29, the American Clinical Laboratory Association (ACLA) sued the Food and Drug Administration (FDA) in an effort to vacate its recent final rule that will gradually phase out FDA’s long-standing policy of enforcement...more

Goodwin

Lawsuit Filed Challenging FDA Final Rule Regulating Laboratory Developed Tests

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On May 29, 2024, a lawsuit was filed in the U.S. District Court for the Eastern District of Texas, challenging the U.S. Food and Drug Administration’s final rule concerning the regulatory status of laboratory developed tests...more

Foley & Lardner LLP

What You Need to Know about President Trump’s Executive Order to Strengthen the Domestic Supply Chain for Essential Drugs and...

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On August 6, 2020, President Trump signed an Executive Order (“Order”) to ensure essential medicines, medical countermeasures, and critical inputs are made in the United States. The President recognized that reliable...more

Holland & Knight LLP

Healthcare Law Update: October 2019

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In recent years, the healthcare industry has been turning greater attention to the need to engage or involve patients in developing new technologies and systems to improve healthcare delivery. These patient engagement...more

Bergeson & Campbell, P.C.

Wrap-Up of Federal and State Chemical Regulatory Developments, September 2015

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EPA Releases TSCA Assessment Documents For Flame Retardant Chemicals: On August 18, 2014, the U.S. Environmental Protection Agency (EPA) released for public comment three Problem Formulation and Initial Assessment documents...more

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