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147 results found

Article

Morrison & Foerster LLP | USA | 2 Jul 2019

Committed to Clarity: FDA’s Dedication to Transparency with the End of ASR

On June 21, the Food and Drug Administration (FDA) released a report titled “Statement on agency’s efforts to increase transparency in medical device

Article

Morrison & Foerster LLP | USA | 5 Jun 2019

Supreme Court decides prescription drug preemption case in favor of drug manufacturer

The United States Supreme Court finally clarified its 11-year-old “clear evidence” standard for pharmaceutical preemption. In its much-anticipated

Article

Morrison & Foerster LLP | USA | 24 Oct 2018

FDA Announces New Efforts to Combat Cybersecurity Threats in Medical Devices

FDA is tackling cybersecurity threats head-on and expects industry to do the same. Earlier this month, FDA commissioner Scott Gottlieb, M.D

Article

Morrison & Foerster LLP | USA | 20 Aug 2018

FDA Advisory Committee Materials Qualify as 102(b) Prior Art

In this consolidated appeal from decisions invalidating as obvious certain claims in six IPRs, appellant argued that the PTAB erroneously found

Article

Morrison & Foerster LLP | USA | 20 Aug 2018

FDA Releases Biosimilar Action Plan; Solicits Stakeholder Input; Public Hearing on September 4th

On July 18, the FDA released its Biosimilar Action Plan, which focuses on "four key areas:" improving efficiency of the biosimilar and interchangeable

Article

Morrison & Foerster LLP | USA | 6 Jun 2018

Hatch-Waxman and BPCIA Developments in May 2018

This month, we highlight significant developments in May 2018, including a stunning reverse payment decision at the FTC, draft guidance from the FDA

Article

Morrison & Foerster LLP | USA | 5 Mar 2018

Round One Goes to Roundup: Court Temporarily Enjoins Proposition 65 Warnings for Glyphosate and Glyphosate Residues in Foods

Last Monday, a federal judge temporarily barred California from requiring cancer warnings on products that contain detectable amounts of

Article

Morrison & Foerster LLP | USA | 16 Jan 2018

3D Printing Meets Medical Devices: FDA Weighs In On Additive Manufacturing

In December, the U.S. Food and Drug Administration (FDA) issued guidance on Technical Considerations for Additive Manufactured Medical Devices. The

Article

Morrison & Foerster LLP | USA | 11 Jul 2017

FDA’s Denial of Citizen’s Petition “Clear” Enough for Preemption of Failure-to-Warn Claims

The Tenth Circuit recently upheld a Utah district court’s finding that a branded drug manufacturer could not be held liable for failing to warn

Article

Morrison & Foerster LLP | USA | 12 Jun 2017

The Revival of ECJ Lawsuits: Sweet Tooth For Plaintiffs, or Toothless Claims?

On May 22, 2017, plaintiff Jessica Gomez filed an opposition on behalf of a putative class of consumers urging a federal district court judge not to

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