News & Analysis as of

Regulatory Requirements Risk Management Digital Health

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

From Algorithms to Approvals: Navigating AI in Drug and Biological Product Regulation

On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

Ropes & Gray LLP on

In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Society of Corporate Compliance and Ethics...

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Compliance & Ethics Conference - March 8th, Washington, DC

Looking for compliance education and networking in your area? SCCE & HCCA’s Regional Compliance & Ethics Conferences bring compliance practitioners from all disciplines together for convenient, local compliance education....more

Health Care Compliance Association (HCCA)

[Event] Regional Healthcare Compliance Conference - August 5th, Philadelphia, PA

Looking for compliance training and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance training, including updates on the latest news in regulatory...more

McDermott Will & Emery

[Webinar] Digital Health Venture Series, Part 2: Preparing Your Start-Up for the Funding Process - December 15th, 1:00 pm - 2:00...

McDermott Will & Emery on

The unique business opportunities created by digital health companies can carry heightened regulatory risks. As investors increase their focus on the digital health sector and as digital health companies engage in more...more

McDermott Will & Emery

[Webinar] Digital Health Venture Series, Part 1: What to Look For When Investing in Digital Health - December 8th, 1:00 pm - 2:00...

McDermott Will & Emery on

The unique business opportunities created by digital health companies can carry heightened regulatory risks. As investors increase their focus on the digital health sector and as digital health companies engage in more...more

Hogan Lovells

Digital health: Understanding the new responsibilities facing life sciences companies related to collecting and processing...

Hogan Lovells on

In May 2018, the General Data Protection Regulation (GDPR) entered into effect in EU member states, replacing a longstanding and less rigorous data and e-privacy directive. ...more

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