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Dykema Gossett PLLC | USA | 2 Apr 2019

FDA Statement on Cannabis-Containing and Cannabis-Derived Products

On April 2, 2019 the FDA further described its upcoming effort to regulate or at least discuss the regulation of cannabis-containing and…

Morgan, Lewis & Bockius LLP | USA | 8 Mar 2019

FDA Sings the Orange Book Blues to Announce a Potential New Patent Listing Approach

The US Food and Drug Administration (FDA or Agency) on January 30 signaled what could be an about-face with regard to its role administering the List…

Jones Day | USA | 31 Jan 2019

Appellate Standing Not Precluded By Inability To Maintain Hatch-Waxman Suit

Mylan Pharmaceuticals, Inc. petitioned for inter partes review (IPR) of U.S. Patent No. 6,858,650 (the “‘650 Patent”), which is owned by UCB Pharma…

Hogan Lovells | USA | 30 Oct 2018

CMS considers linking Medicare drug payment rates to international prices

On October 25, 2018, the Centers for Medicare & Medicaid Services (CMS) issued an Advance Notice of Proposed Rulemaking (ANPRM) describing a potential…

Seyfarth Shaw LLP | USA | 24 Oct 2018

Teva Sues FDA Alleging Unlawful Interpretation of the Definition of “First Applicant”

The FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity for ANDA applicants applying for approval of certain drugs…

Hall & Wilcox | Australia | 21 Aug 2018

Enterprise agreement approvals - how long is seven days?

Recent Fair Work Commission decisions have confirmed that employers must meet strict technical requirements before enterprise agreements will be…

McGuireWoods LLP | USA | 23 Jul 2018

Washington Healthcare Update - Jul 23, 2018

The House of Representatives approved the first major change to federal regulation of the over-the-counter drug industry in 40 years. The bill, H.R…

Frankfurt Kurnit Klein & Selz PC | USA | 20 Jul 2018

When is False Advertising a Crime?

When is false advertising a crime? That was the issue recently considered by the First Circuit in United States v. Arif. Mustafa Hassan Arif plead…

Holland & Knight LLP | USA | 15 Jun 2018

FDA Guidance on HCEI and Communications to Payors of Unapproved Products and Uses

On June 12, 2018, the U.S. Food and Drug Administration (FDA) released draft guidance entitled "Drug and Device Manufacturer Communications With…

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP | USA | 5 Mar 2018

FDA Guidance on Drugs for Treatment of Partial Onset Seizures: Extrapolation of Efficacy from Adults to Pediatric Patients

On February 15, 2018, FDA issued draft guidance to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS)…
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