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FDA Delays Enforcement of MOCRA Deadlines for Facility Registration and Product Listing to July 1, 2024

By John Wyand, Jennifer Tharp, Jennifer Satterfield and Madeline Mischler on Posted in FDA, Life Sciences
Background President Biden signed into law the “Consolidated Appropriations Act, 2023” on December 29, 2022. The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see … Continue Reading

Revamping Cosmetics Safety and Regulation: Updates from FDA on Regulatory Changes under MOCRA.

By John Wyand, Jennifer Tharp, Jennifer Satterfield and Madeline Mischler on Posted in FDA, Life Sciences
On December 29, 2022, President Biden signed into law the “Consolidated Appropriations Act, 2023.” The Act includes the Modernization of Cosmetics Regulation Act of 2022 (“MOCRA”), which increased the authority of the United States Food and Drug Administration (FDA) to regulate cosmetics products and provide enhanced cosmetics protections for consumers. For insight, please see our … Continue Reading

Use of Artificial Intelligence in Healthcare Industry in Mainland China

By Nicholas Chan on Posted in Artificial Intelligence, China, Life Sciences, Medical Device
With breakthroughs in artificial intelligence (“AI”), the healthcare industry has experienced rapid development. Since 2016, China has issued a series of relevant policies, including the “Internet+” Artificial Intelligence Three-Year Action and Implementation Plan, Guiding Opinions on Promoting and Regulating the Application and Development of Big Data in Health and Medical Care and the “Healthy China … Continue Reading

Singapore Open-sources World’s First AI Governance Testing Framework and Toolkit

By Charmian Aw on Posted in Artificial Intelligence, International, Life Sciences, Technology
Singapore has open-sourced the world’s first AI governance testing framework and toolkit, called “AI Verify”. As a single integrated software toolkit operating within a user’s enterprise environment, AI Verify allows users to conduct technical tests on their AI models, and record process checks for reporting to any shareholders or regulatory bodies. Additional toolkits can be … Continue Reading

Roadmap to the Phased Transition Process for Medical Devices after Covid-19 Public Health Emergency

By John Wyand, Charli Davis, Jennifer Tharp and Nicole Bothwell on Posted in COVID-19, FDA, Life Sciences, Medical Device
On March 27, 2023, the U.S. Food &Drug Administration (FDA) released two final guidance documents to assist with the transition of medical devices that were legally distributed: (1) subject to certain enforcement policies issued during the COVID-19 public health emergency (PHE) or (2) Emergency Use Authorizations (EUAs). Manufacturers, distributors, and industry stakeholders that have products … Continue Reading

Will Patents Become More Political? The PTO Begins to Implement Arthrex

By Squire Patton Boggs on Posted in Life Sciences, Technology
In United States v Arthrex, the Supreme Court held that 35 U.S.C. §6(c), which sets forth the authority of Patent Trial & Appeal Board (“PTAB”) Administrative Patent Judges (“APJs”), is unconstitutional because APJs effectively wield the power of principal officers (who require Senate confirmation) while being appointed as inferior officers (who do not require Senate confirmation). … Continue Reading

The Medical Device Regulation, COVID-19 and Brexit

By Adrian Spooner on Posted in Brexit, COVID-19, EU, Life Sciences, Medical Device
Regulation 2020/561 (Regulation) was passed by the EU in April last year to take account of issues raised by the COVID-19 pandemic and to defer the date of application of certain provisions of Regulation 2017/745 (MDR) by one year.  The Regulation was published on 24 April 2020 through an EU accelerated procedure, and although the … Continue Reading

AHLA Podcast: Labor and Employment Issues with COVID-19 Vaccine Distribution

By Squire Patton Boggs on Posted in COVID-19, Labor and Employment, Life Sciences
Squire Patton Boggs Of Counsel Will Kishman recently participated with Kristin McGurn, Seyfarth Shaw LLP, in an American Health Law Association’s (AHLA) Speaking of Health Law podcast, “Labor and Employment Issues with COVID-19 Vaccine Distribution.”  It has been published on the AHLA’s Speaking of Health Law channel, and is available to the public.  You may … Continue Reading

Senators Announce Bipartisan Bill Requiring Pharmaceutical Supply Chain Report

By John Wyand on Posted in Legislation, Life Sciences, Pharmaceutical
U.S. Senators Marco Rubio (R-FL) and Elizabeth Warren (D-MA) recently announced plans to cosponsor S. 4191, the United States Pharmaceutical Supply Chain Review Act. According to bill text released by Senator Warren’s office, the bill directs the Federal Trade Commission (FTC) and the Secretary of the Treasury, in consultation with the Secretary of the Treasury, … Continue Reading

Digital Health Update: Recent FDA Cyber Initiatives

By Jennifer Tharp on Posted in Cybersecurity, Data Protection, Department of Health and Human Services, Digital Health, FDA, Life Sciences, Medical Device, Policy, Regulatory Compliance, Technology
The Food and Drug Administration (“FDA”) has greatly increased its activity around cybersecurity initiatives and medical devices. As we approach the end of the year, this is a great opportunity to review recent developments. FDA Medical Device Cybersecurity Guidance On October 18, 2018, the FDA published draft guidance, “Content of Premarket Submissions for Management of … Continue Reading

Healthcare Industry Increasingly Using Trade Secret Litigation to Protect Intellectual Property Rights

By Rachael Harris on Posted in Life Sciences, Technology
A recent report from Lex Machina shows that an increasing number of companies (no doubt including those in the healthcare industry) are turning to the assertion of trade secret claims to protect their intellectual property rights in federal courts – in large part thanks to the passage of the Defend Trade Secret Acts (“DTSA”). Between … Continue Reading

Squire Patton Boggs Attorneys Publish Practical Law Practice Note on State Legalized Marijuana Businesses and Access to the Bankruptcy Code

By John Wyand on Posted in Bankruptcy, Compliance, DEA, DOJ, Drug, FDA, Life Sciences, Pharmaceutical, Policy
The June 13, 2018 publication of Practical Law features a Practice Note co-written by Squire Patton Boggs attorneys Mark A. Salzberg, Elliot M. Smith, John E. Wyand and Sarah H. Stec titled “State Legalized Marijuana Businesses and Access to the Bankruptcy Code”. The Practice Note discusses the federal statutory scheme governing marijuana, its tension with … Continue Reading

Right to Try Investigational Drugs Signed Into Law

By John Wyand on Posted in Department of Health and Human Services, FDA, Insurance, Life Sciences, Pharmaceutical, Policy
Right to Try Investigational Drugs Signed Into Law On May 30, 2018, S. 204, the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 (Pub. L. No. 115-176, “Right to Try Act”) was signed into law. The Right to Try Act amends the Federal Food, Drug, and Cosmetic Act … Continue Reading

FDA Issues Guidance on Clinical and Patient Decision Support Software

By Squire Patton Boggs and John Wyand on Posted in FDA, Life Sciences, Medical Device, Medical Device, Publications
On December 8, 2017, the Food and Drug Administration (FDA) published a notice of availability for the Clinical and Patient Decision Support Software – Clinical and Patient Decision Support Software – Draft Guidance for Industry and Food and Drug Administration Staff (“Draft Guidance”). The Draft Guidance, available here, provides clarity on the scope of FDA’s … Continue Reading

National Institutes of Health Extends Effective Date of sIRB Policy

By Squire Patton Boggs and John Wyand on Posted in Life Sciences, Medical Device, NIH, Policy, Research
Recently, the National Institutes of Health (“NIH”) extended the effective date of its policy on the use of the single Institutional Review Board (“IRB” or “sIRB” if a single IRB) to January 25, 2018. NIH created the sIRB policy to establish the expectation that a sIRB be used in the ethical review of multi-site, domestic, … Continue Reading
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