News & Analysis as of

New Guidance Executive Orders Food and Drug Administration (FDA)

Ropes & Gray LLP

FDA Finalizes Guidance on Remote Regulatory Assessments, But How Will They Support the Administration’s Manufacturing-Related...

Ropes & Gray LLP on

In response to travel restrictions imposed during the COVID-19 pandemic, the U.S. Food and Drug Administration (“FDA”) began conducting remote regulatory assessments (“RRAs”) of medical products companies and other...more

Morgan Lewis - As Prescribed

Navigating FDA’s Evolving Approach to Guidance Publication for Medical Products

Guidance development and publication from the Food and Drug Administration (FDA) has long been considered an essential element of medical product development, approval, and regulation. While temporary pauses in guidance...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in the Fourth Quarter of 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....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

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

ArentFox Schiff

Vaccine Mandate for Government Contractors: Guidance and FAR Class Deviation Bring Clarity and Questions

ArentFox Schiff on

On September 9, 2021, President Biden signed Executive Order 14042, "Ensuring Adequate COVID Safety Protocols for Federal Contractors," that directed agencies to include a clause in new contracts, options, and extensions...more

MoFo Employment Law Commentary (ELC)

New Guidance On COVID-19 Protocols For Contractor Employees At Federal Facilities

On September 17, 2021, the Safer Federal Workforce Task Force (the “Task Force”) issued updated guidance (the “Guidance”) to federal agencies about COVID-19 safety protocols for employees of federal contractors and federal...more

Jones Day

Federal Agencies Launch New Websites Containing All Guidance Documents Still In Effect - Guidance documents not included on the...

Jones Day on

This action implements a portion of the President's recent Executive Order 13891, "Promoting The Rule Of Law Through Improved Agency Guidance Documents." In that executive order, the President directed agencies to review...more

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