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Regulatory Requirements Life Sciences Enforcement Actions

Sheppard Mullin Richter & Hampton LLP

FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company

On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations...more

McDermott Will & Emery

[Hybrid Event] Healthcare Litigation, Compliance and Investigations Forum 2023 - November 1st, Chicago, IL

McDermott Will & Emery on

McDermott’s Healthcare Litigation, Compliance and Investigations Forum is back when you need it the most. Heightened regulatory scrutiny and enforcement activity pose legal, financial and reputational risks for healthcare...more

McDermott Will & Emery

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

McDermott Will & Emery on

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 & Emery

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

McDermott Will & Emery on

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

Morgan Lewis - As Prescribed

Fourteen Years Later, FDA Flexes Its Clinicaltrials.gov Enforcement Authority

FDA recently issued its first clinicaltrials.gov notice of noncompliance to a clinical trial sponsor for failure to submit clinical trial results to the National Institutes of Health (NIH) databank. ...more

McDermott Will & Emery

[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 & Emery

[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 & Emery

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

McDermott Will & Emery on

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 & Emery

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

McDermott Will & Emery on

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 & Emery

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

McDermott Will & Emery on

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

Manatt, Phelps & Phillips, LLP

[Webinar] What’s Past Is Present: Key Regulatory Trends Impacting Health Care/Life Sciences - March 23rd, 3:00 pm - 4:00 pm ET

From Pricing to Compliance to Coordinated Care, a Wide Range of Critical Areas Saw Regulatory Changes in 2020 That Will Impact the Health Care and Life Sciences Industries in 2021—and Beyond. Find Out How Your Organization...more

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