Manufacturers, Healthcare, FDA Approval

California Supreme Court Will Review Novel Negligence Theory for Pharmaceutical Manufacturers

Jones Day on 5/15/2024

The Situation: The California Supreme Court recently granted review of a California Court of Appeal decision, Gilead Life Sciences, Inc. v. The Superior Court of the City and County of San Francisco, that made waves in the...more

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on 10/31/2023

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

FDA Approves Neuralink to Begin Human Trials of Brain Implants

Knobbe Martens on 6/16/2023

Neuralink, the biotechnology company founded by Elon Musk, has received approval from the U.S. Food and Drug Administration (FDA) to commence human trials of its implantable brain-computer interface device. Recruitment for...more

Device Modernization Series: FDA’s Changes to the 510(k) Program

Mintz - Health Care Viewpoints on 2/22/2019

In our “FDA 2018 Year in Review (and a Few Thoughts on 2019)” post and recent webinar, we observed that we may look back at 2018 as the beginning of the end for the 510(k) program as it has existed since the 1976 Medical...more

FDA releases final guidance document on PMA manufacturing site change supplements

Hogan Lovells on 12/21/2018

On 17 December 2018 the U.S. Food and Drug Administration (FDA) issued a final guidance document intended to help manufacturers determine the appropriate premarket approval (PMA) application supplement reporting pathway for...more

FDA proposes new regulations to govern De Novo requests – will the process live up to its promise?

Hogan Lovells on 12/13/2018

Last week the Food and Drug Administration (FDA) issued a proposed set of new regulations to further define and update the De Novo review process. Although De Novo review has been available for two decades, for the past 20...more

Challenging Drug Patents: Does AIDS Healthcare Raise an “Actual Controversy”?

Robins Kaplan LLP on 8/23/2018

Manufacturers who want to introduce generic drugs face a special delay and enjoy a corresponding special right to challenge patents on branded drugs based on the great compromise in the Hatch-Waxman Act. ...more

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