News & Analysis as of

Life Sciences Regulatory Requirements Corporate Counsel

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On January 6, 2025, the FDA released draft guidance on using artificial intelligence (AI) in regulatory decision-making for drugs and biological products. The draft guidance – the first of its kind from the agency – aims to...more

McDermott Will & Schulte

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Digital Health - June 8th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

McDermott Will & Schulte

[Ongoing Program] Life Sciences Bootcamp Series - FDA and IP - May 25th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

McDermott Will & Schulte

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Consumer Protection and FDA - May 18th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

McDermott Will & Schulte

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Employment Hot Topics - May 17th, 12:30 pm ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

McDermott Will & Schulte

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Cross-Border Licensing and Transactions - May 11th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

McDermott Will & Schulte

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Enforcement Trends and FCPA - May 4th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

McDermott Will & Schulte

[Ongoing Program] 2021 Life Sciences Bootcamp Series - Government Contracting and Drug Pricing - April 27th, 11:00 am ET

Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic. The transactional and regulatory issues as...more

The Volkov Law Group

Delaware Court Increases Scrutiny of Corporate Board Oversight and Monitoring of Compliance Programs

The Volkov Law Group on

On October 1, 2019, in In re Clovis Oncology, Inc. Derivative Litigation, a Delaware Chancery Court denied a motion to dismiss the plaintiffs’ claims under the Caremark decision against individual directors for failing to...more

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