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Erectile Dysfunction Drug Notice Sought

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The Physicians Committee for Responsible Medicine asks FDA to require specific wording in labeling and packaging for erectile dysf...

Rist Cath Radial Access Long Sheath Cleared

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FDA clears a Rist Neurovascular 510(k) for the Rist Cath Radial Access Long Sheath and its use to introduce interventional devices...

Info Collection on Device Safety Communications

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Federal Register notice: FDA sends to OMB an information collection extension on Testing Communications on Medical Devices and Rad...

Info Collection on Social/Behavioral Research

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Federal Register notice: FDA seeks comments on a new information collection for qualitative data to support social and behavioral ...

Trump Budget Proposes Flat $6.2 Billion FDA Budget

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President Trump proposes a relatively flat (1.6% increase) $6.2 billion budget for FDAs fiscal year 2021 budget, which includes $3...

FDA Phone Safety Review: No Adverse Health Effects

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A new FDA literature review on cell phone radiofrequency radiation exposure on human health finds no quantifiable adverse health e...

Lilly Reports Miss on Alzheimers Study

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Eli Lilly says it does not plan to pursue an NDA submission for solanezumab for treating patients with dominantly inherited Alzhei...

Info Collection on Device Risk Allegations

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Federal Register notice: FDA seeks comments on an information collection entitled Electronic Submission Process for Voluntary Alle...

Janssen sBLA for Darzalex Combination Use for Myeloma

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FDA accepts for review a Janssen Pharmaceutical supplemental BLA for Darzalex (daratumumab) for use in combination with Amgens Kyp...

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 2/7/2020.