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Food and Drug Administration Challenges for 2023

Food and Drug Administration Challenges for 2023
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2023: Another Year Chock Full of Challenges for FDA | Mintz - Health Care Viewpoints

At the start of 2022, we reflected on what the Food and Drug Administration (FDA) had accomplished during the preceding 12 months and the challenges that could be ahead for the agency. ....

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Better Therapeutics, Inc. (NASDAQ:BTTX) Q3 2023 Earnings Call Transcript

Better Therapeutics, Inc. (NASDAQ:BTTX) Q3 2023 Earnings Call Transcript November 10, 2023 Operator: Good day and thank you for standing by. Welcome to the Better Therapeutics’ Third Quarter 2023 Business Update Call. At this time all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions]. Please […] ....

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Say What You Say: FDA Issues SIUU Draft Guidance | Arnall Golden Gregory LLP

In its 1997 hit song “Don’t Go Away,” the rock band, Oasis, sang, “Say what you say . . . ’cause I need more time . . . just to make things right.” The lyrics must have been playing in. ....

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FDA Issues Revised Draft Guidance on "Scientific Information on Unapproved Uses Communications" | Foley Hoag LLP

On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs. ....

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