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Eton Pharma Gets Complete Response Letter

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FDA sends Eton Pharmaceuticals a second complete response letter on its NDA for dehydrated alcohol injection for treating methanol...

Compounded Drug Wholesaling Prohibition Guide

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Federal Register notice: FDA makes available a draft guidance entitled Prohibition on Wholesaling Under Section 503B of the Federa...

4 Observations in Prisma Health FDA-483

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FDA releases the form FDA-483 with four observations issued following an inspection at the Prisma Health outsourcing facility in S...

Guide on Quantitative Data in DTC Materials

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Federal Register notice: FDA makes available a final guidance entitled Presenting Quantitative Efficacy and Risk Information in Di...

FDA Bars Chengdu KeCheng Drugs

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FDA issues an Import Alert against all drugs from Chinas Chengdu KeCheng Fine Chemicals and a Warning Letter about its continuing ...

New Lilly Drug Meets Endpoints on Weight Loss

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Eli Lilly says new Phase 2 data on weight-loss candidate retatrutide met primary and secondary endpoints.

Info Collection on e-Import Entries Revised

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Federal Register notice: FDA sends to OMB an information collection revision entitled Imports and Electronic Import Entries.

FDA Withdraws Oxandrolone NDA/ANDAs

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Federal Register notice: FDA withdraws the approval of a Gemini Laboratories NDA for Oxandrin (oxandrolone) tablets and four ANDAs...

Supply Chain Violations at Safe Chain Solutions

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FDA warns Cambridge, MD-based Safe Chain Solutions about violations of the Drug Supply Chain Security Act in its work as a wholesa...

DTC Efficacy and Risk Information Guidance

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FDA publishes a guidance on how to present more consumer-friendly efficacy and risk information in direct-to-consumer promotional ...