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62% of FDA-approved Biologics Have Boxed Warnings

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A Milwaukee Journal Sentinel investigative report says 62% of biologics approved by FDA carry a Boxed Warning, much higher than th...

Info Collection Extension for Emergency Use Guide

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Federal Register notice: FDA seeks an information collection extension on its guidance on emergency use authorizations.

Amarin Planning Synthetic Omega-3 Response

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Amarin says it will respond to a citizen petition asking for a synthetic omega-3 exclusion from dietary supplement structural requ...

Draft Guide on Prostate Cancer Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Advanced Prostate Cancer: Developing Gonadotropin-Releasing...

Review iPLEDGE Isotretinoin Fetal Defects: Researchers

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Researchers call for reevaluation of the iPLEDGE isotretinoin program and exploration of new approaches to lower fetal exposure to...

Pear Therapeutics Seeks Somryst Marketing OK

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Pear Therapeutics says it filed a request for marketing authorization with FDA for its Somryst prescription digital therapeutic to...

Since Our Last Issue ...

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Industry news you may have missed since our last issue.

FDA Draft Guide on X-ray Equipment Regs

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FDA posts a draft guidance entitled Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment...

Proposed Rule on Drug Labeling Changes Withdrawn

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Federal Register proposed rule withdrawal: FDA announces the withdrawal of a proposed rule on Supplemental Applications Proposing ...

Guide on Manufacturing Site Change Supplements

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FDA posts a guidance entitled Manufacturing Site Change Supplements: Content and Submission.