News & Analysis as of

Life Sciences Adverse Events Prescription Drugs

Epstein Becker & Green

Unpacking Averages: Adverse Events for Device-Lead Combination Products

Combination products present a tremendous opportunity to improve health outcomes, because they leverage multiple disciplines.  If we were, for example, to focus on drugs alone with little thought to how they might be...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

American Conference Institute (ACI)

[Virtual Event] 36th Annual FDA Boot Camp - March 24th - 25th, 8:15 am - 1:45 pm EDT

ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more

Arnall Golden Gregory LLP

I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Quality Agreements for FDA-Regulated Products: Looking Under...

AGG is proud to introduce our newest podcast series titled “I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues.” Each month, we will release a new podcast where different members of our Food and Drug practice...more

Morgan Lewis

FDA Issues Guidance on Postmarket Adverse Event Reporting During Pandemics

Morgan Lewis on

In light of the coronavirus (COVID-19) outbreak, the US Food and Drug Administration (FDA) recently issued a guidance on adverse event (AE) report for drugs, biologics, medical devices, dietary supplements, and other products...more

Skadden, Arps, Slate, Meagher & Flom LLP

Life Sciences Companies May Face More Scrutiny in Using FDA Documents to Dismiss Securities Cases

Following a recent decision from the U.S. Court of Appeals for the Ninth Circuit in Khoja v. Orexigen Therapeutics, Inc., plaintiffs alleging securities fraud against companies in the pharmaceutical and life sciences sector...more

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