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Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

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The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

White & Case LLP on

Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Hogan Lovells

AI Health Law & Policy: FDA’s rapidly evolving regulatory paradigms

Hogan Lovells on

Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more

Stikeman Elliott LLP

Health Canada Consults on Pathway for Health Products Containing CBD

Stikeman Elliott LLP on

Health Canada recently announced that it is exploring a regulatory pathway that would allow products containing cannabidiol (“CBD”) to be purchased without a prescription. Under the current regulatory scheme, all health...more

Sheppard Mullin Richter & Hampton LLP

2025 Top-of-Mind Issues for Life Sciences Companies

DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more

Ropes & Gray LLP

FDA and OHRP Issue Draft Guidance on Including Biopsies in Clinical Trials

Ropes & Gray LLP on

On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more

Akin Gump Strauss Hauer & Feld LLP

FDA Announces Draft Guidance on Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial Is Underway

On January 6, the FDA announced the availability of draft guidance on accelerated approval for drugs and biological products, and consideration for determining whether a confirmatory trial is underway. Under the Consolidated...more

McDermott Will & Schulte

2024 Health Report - Government Actions Affecting Food, Drug and Medical Device Industries

The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more

McDermott Will & Schulte

Healthcare Regulatory Check-Up Newsletter | December 2023 Recap

This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

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