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Marketing

2 Prescription Drug Promotion Studies Proposed

The CDER Office of Prescription Drug Promotion proposes to study consumer and healthcare provider perceptions about drugs that come with medication tr...

Medical Devices

FDA Approves Medtronic Indication for Onyx Stents

FDA approves two Medtronic drug-eluting stents for use in treating non-left main bifurcation lesions in the heart.

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Medical Devices

FDA Clears AI Colon Polyp Detector

FDA clears an Iterative Scopes 510(k) for SKOUT, a computer-aided polyp detection device for adults undergoing colorectal cancer screening.

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Human Drugs

User Fee Reauthorization Agreement Reached in Senate

Senate Health, Education, Labor and Pensions Committee leaders reach agreement to reauthorize FDAs user fee programs for an additional five years, wit...

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Human Drugs

Lillys Retevmo Gains Regular FDA Approval

FDA grants regular approval to Eli Lilly for its previously accelerated-approval Retevmo (selpercatinib) for treating certain adult patients with loca...

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Human Drugs

Accelerated Approval On- and Off-Ramp Approaches

Staff in the FDA Oncology Center of Excellence say ways must be found to improve studies leading to accelerated approval to shorten the time in which ...

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Human Drugs

Panel Votes Down Spectrum Lung Cancer Drug

FDAs Oncologic Drugs Advisory Committee votes 9-4 against recommending accelerated approval for Spectrum Pharmaceuticals Pozenveo (poziotinib) and its...

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FDA General

DoJ Increasing Corporate Enforcement

Former U.S. Attorney Gregory Brower discusses four takeaways from a recent Department of Justice memo on increased corporate enforcement actions.

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Human Drugs

Guide on Drug Covered Product Authorizations

FDA posts a draft guidance entitled How to Obtain a Covered Product Authorization for generic drug developers having trouble getting samples for devel...

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Federal Register

Rx NIX Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that GlaxoSmithKlines prescription-only NIX (permethrin) 1% topical creme rinse was not withdrawn from sale fo...