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Foley & Lardner LLP

AI Drug Development: FDA Releases Draft Guidance

Foley & Lardner LLP on

On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more

Goodwin

FDA Platform Technology Draft Guidance Highlights Utility of Obscure Patent Term Extension Provision

Goodwin on

As discussed in a prior Goodwin Alert, the US Food and Drug Administration (FDA) recently released Draft Guidance for designating a platform technology for drug development pursuant to § 560k of the Federal Food, Drug, and...more

Troutman Pepper Locke

How to Get that Final Approval - FDA Issues New Draft Guidance

Troutman Pepper Locke on

On January 16, 2019, the United States Food and Drug Administration issued a new draft Guidance entitled “ANDA Submissions –Amendments and Requests for Final Approval to Tentatively Approved ANDAs”. This new FDA Guidance...more

Goodwin

Year in Review: Top Five Legal Developments of 2017

Goodwin on

Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

Knobbe Martens

FDA Issues Draft Guidance on Dissemination of Patient-Specific Information from Devices

Knobbe Martens on

On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more

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