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Life Sciences › FDA Approval › Product Labels

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

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Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

American Conference Institute (ACI)

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

American Conference Institute (ACI) on

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

American Conference Institute (ACI) on

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

Seyfarth Shaw LLP

FDA Authorizes Synthetic Nasal Swab to Increase COVID-19 Testing

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Late last week, the U.S. Food and Drug Administration (FDA) announced it approved the use of spun synthetic swabs similar to Q-tips for use in testing for COVID-19....more

Seyfarth Shaw LLP

FDA Issues Guidance Documents Directed to Blood Donations as Part of COVID-19 Public Health Emergency Measures

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To address critical shortages of blood and plasma during the COVID-19 pandemic, the U.S. Food and Drug Administration (the “FDA”) released several guidance documents on April 2, 2020.  ...more

American Conference Institute (ACI)

[Event] FDA BOOT CAMP - March 25 - 27, 2019, New York, NY

American Conference Institute (ACI) on

Obtain the guidance you need to master the difficult area of FDA regulatory law - For over 15 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of...more

Skadden, Arps, Slate, Meagher & Flom LLP

A Dialogue With Corporate Counsel: Skadden’s Eighth Annual Pharmaceutical and Medical Device Seminar

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On October 30, 2018, Skadden hosted its Eighth Annual Pharmaceutical and Medical Device Enforcement and Litigation Seminar in New York City, which focused on U.S. enforcement issues faced by companies throughout the industry....more

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