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CDER Conversations

Interviews with experts from FDA's Center for Drug Evaluation and Research (CDER) on priorities, projects, and initiatives.

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Commemorating the 15th Anniversary of the Biologics Price Competition and Innovation Act

FDA expert discusses the Biologics Price Competition and Innovation Act

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Untitled Letters

These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters.

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Study casts doubt on gluten as cause of gut ailments among non-coeliacs

Research finds people with self-declared gluten sensitivity experienced symptoms whether or not they ate glutenPeople who report being gluten intolerant but do not have coeliac disease may be experien

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STAT+: Your questions answered: How insurers are using AI

In this edition of STAT's AI Prognosis newsletter: A deeper look at how insurers use AI, and implications for patients.

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People doing intense exercise experience time warp, study finds

Research suggests those who push themselves when working out perceive time to move more slowlyIf your sessions at the gym seem to drag on for hours, you are in good company.

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Navigating Controlled Correspondences to Support Generic Drug Development - 02/27/2025

Navigating Controlled Correspondences to Support Generic Drug Development

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Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act

Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or

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Altis says its AI tool can cut risk in cancer trials

Biotech stories you need to read, brought to you by The Readout.

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Vax Skeptic to Lead Autism Study; Liver Damage After RFK Jr. Recs; 'Chemtrail' Bans?

(MedPage Today) -- Note that some links may require registration or subscription. MedPage Today is collecting stories of HHS staffers across all agencies affected by Trump administration cuts.

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