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Goodwin

FTC Comment on FDA Draft Guidance on Interchangeability

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We recently posted on a new FDA draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers,” aimed at providing “answers to commonly asked questions...more

Goodwin

FDA Issues Draft Guidance on Postapproval Manufacturing Changes to Biosimilar Products

Goodwin on

​​​​​​​On July 23, 2024, the FDA issued a draft guidance entitled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products Questions and Answers.”...more

Arnall Golden Gregory LLP

This is a Land of Confusion: FDA Issues Q&A Guidance on Addressing Misinformation About Medical Devices and Prescription Drugs

Arnall Golden Gregory LLP on

In 1986, from the Invisible Touch album, the rock band Genesis sang a song about “Land of Confusion” (remember the weird video with puppets?). Almost 40 years later, in July 2024, the Food and Drug Administration issued a...more

Arnall Golden Gregory LLP

[Webinar] FDA Tries to Keep Up: How FDA and Industry Are Trying to Keep Up With Artificial Intelligence - September 13th, 2:00 pm...

Arnall Golden Gregory LLP on

FDA has cleared or approved hundreds of products that work with artificial intelligence (“AI”) and acknowledges that the agency and industry need help navigating how FDA-regulated products engage with AI. In response to the...more

Manatt, Phelps & Phillips, LLP

FDA Issues New Draft Guidance on Clinical Testing of Psychedelic Drugs

Manatt, Phelps & Phillips, LLP on

On June 23, 2023, FDA issued a first-of-its-kind draft guidance for sponsors of studies of psychedelic drugs. The guidance arrived just as the Psychedelic Science 2023 conference in Denver was wrapping up. Touted as the...more

Knobbe Martens

FDA Issues Draft Guidance for Software Contained in Medical Devices

Knobbe Martens on

On November 3, 2021 the FDA issued draft guidance titled “Content of Premarket Submissions for Device Software Functions.” The final version will eventually replace the FDA’s “Guidance for the Content of Premarket Submissions...more

Seyfarth Shaw LLP

FDA Provides Safety Communication Relating to Use of Antimalarial Drugs Hydroxychloroquine and Chloroquine In the Treatment of...

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The U.S. Food and Drug Administration has permitted limited use of the antimalarial drugs hydroxychloroquine and chloroquine in the treatment of COVID-19 since issuing an Emergency Use Authorization for such drugs on March...more

Goodwin

FDA Releases Draft Guidance To Aid Manufacturers In Developing Insulin Biosimilars

Goodwin on

Beginning on March 23, 2020, the FDA will begin to accept aBLAs for biosimilar insulin products referencing previously approved insulin products.  Prior to this date, insulin products have been approved pursuant to New Drug...more

Stinson LLP

FDA Introduces Safer Technologies Program for Medical Devices

Stinson LLP on

On September 19, FDA issued a draft guidance that continues its trend to incentivize innovation and increase collaboration with industries in order to expedite the premarket review process, the “Safer Technologies Program for...more

Hogan Lovells

FTC backs FDA guidance intended to curtail citizen petition “shenanigans”

Hogan Lovells on

On Tuesday, December 4, the Federal Trade Commission (FTC) announced that it had submitted a comment regarding the Food and Drug Administration’s (FDA) revised draft guidance on citizen petitions. ...more

Mintz - Health Care Viewpoints

FDA 2017 Year in Review: Refining Medical Device Pathways and Introducing Pilot Programs to Promote Quality

Mintz - Health Care Viewpoints on

This is the third installment of our year-in-review series covering major developments at FDA.  While the previous two installments, pertain to FDA actions on drugs and biologics, this post will address developments related...more

K&L Gates LLP

The Next Move in the Name Game: FDA Provides Long-Awaited Draft Guidance on Biosimilar Labeling

K&L Gates LLP on

On March 31, 2016, the U.S. Food and Drug Administration (FDA) released its long-awaited Draft Guidance on labeling for biosimilar products (the “Draft Guidance”) and is currently soliciting comments on its proposals. The...more

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