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Food and Drug Administration (FDA) Today's Popular Updates Executive Orders

Sheppard Mullin Richter & Hampton LLP

Recent Healthcare-Related Artificial Intelligence Developments

AI is here to stay. The development and use of artificial intelligence (“AI”) is rapidly growing in the healthcare landscape with no signs of slowing down. From a governmental perspective, many federal agencies are embracing...more

Akin Gump Strauss Hauer & Feld LLP

President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Key Points - President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Regulating AI: An Overview of Federal Efforts

This first part of a two-part series on U.S. regulation of artificial intelligence systems provides an overview and modern context for the existing regulatory, legal and risk management landscape for AI systems in the U.S.,...more

Ankura

FDA Authorized to Establish New Cybersecurity Standards for Medical Devices: What it Means for Industry

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On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...more

MoFo Life Sciences

The USPTO And The FDA Join Hands To Promote Competition

MoFo Life Sciences on

On November 15, 2022, the Berkeley Center for Law and Technology hosted a webinar to address the recent, unprecedented collaboration between the U.S. Patent and Trademark Office (USPTO) and the Food and Drug Administration...more

Fish & Richardson

Biosimilars 2021 Year in Review

Fish & Richardson on

2021 saw several important milestones in the biosimilars space, including the much anticipated first interchangeable designations by FDA and the approval of the first ophthalmology biosimilar. The biosimilar market also...more

Jackson Lewis P.C.

Puerto Rico: COVID-19 Boosters Required for Workers in Healthcare, Educational Settings

Jackson Lewis P.C. on

Amidst increasing positive COVID-19 cases in Puerto Rico, Governor Pedro R. Pierluisi has issued an executive order requiring those working in healthcare and education settings to get vaccinated and boosted. Covered...more

Fox Rothschild LLP

NYC Issues Details Of Vaccine Mandate For Indoor Dining, Gyms And Entertainment Venues

Fox Rothschild LLP on

New York City Mayor Bill de Blasio issued an Executive Order on August 16, 2021 setting forth the requirements of the “Key to NYC” vaccine mandate that was announced earlier this month for indoor dining, gyms and...more

MoFo Life Sciences

Vaccine Production And State Intervention In The U.S.

MoFo Life Sciences on

During the COVID-19 pandemic, governments across the globe have become increasingly involved in the private sector. State-owned enterprises have long been common in Asia, but the pandemic has increased their prominence in...more

Hogan Lovells

[Webinar] Health Care and the Internet of Things: New Regulatory Developments - July 25th, 2:00pm EDT

Hogan Lovells on

Please join the Hogan Lovells Communications and FDA practices on Thursday, July 25th for our webinar, Health Care and the Internet of Things: New Regulatory Developments. We will explore new policy initiatives and...more

BakerHostetler

FDA and Pharmacy Weekly Digest - July 2019 #1

BakerHostetler on

Food/Dietary Supplements - FDA Issues Report on Certain Dog Foods – The Food and Drug Administration (FDA) continues to investigate cases of dilated cardiomyopathy (DCM) in dogs consuming certain dog foods. ...more

Wilson Sonsini Goodrich & Rosati

FDA Target of Executive Order on Agricultural Biotechnology

In response to concerns expressed by livestock groups and some in the biotechnology industry over the Food and Drug Administration's (FDA's) approval process for gene editing in animals, the Trump administration issued an...more

Skadden, Arps, Slate, Meagher & Flom LLP

As Congress Struggles With ACA Repeal, Trump Administration Moves Forward With Regulatory Reform

The Trump administration and Republican-led Congress spent substantial time and political capital in 2017 on efforts to repeal and replace the Affordable Care Act (ACA) and enact sweeping Medicaid reform. By the end of the...more

Morrison & Foerster LLP

FDA Embraces Internet of Things: New Draft Guidance on Postmarket Cybersecurity for Medical Devices

The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more

Faegre Drinker Biddle & Reath LLP

FDA Launches Huge Online Database of Adverse Events

As part of the Obama administration's effort to make public information more accessible, the FDA launched openFDA on June 2, 2014. This new database makes nearly 4 million pharmaceutical adverse event reports the FDA...more

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