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Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Essential Pharmaceutical and LEC Custom Products.

User Fee Rate for Medical Countermeasure App

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FDA announces the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2021.

EUA Revoked on Autobio Diagnostics Covid Test

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Federal Register notice: FDA revokes the Emergency Use Authorizations issued to Autobio Diagnostics for the Anti-SARS-CoV2 Rapid T...

OPDP Hits Contrave Sponsored Link

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CDERs Office of Prescription Drug Promotion sends Nalpropion Pharmaceuticals a Warning Letter related to a sponsored link appearin...

Medical Devices Advisory Committee Postponement

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Federal Register notice: FDA postpones until further notice a 10/7 meeting of its Medical Devices Advisory Committees Circulatory ...

FDA Seeks Makena Drug Withdrawal

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In a rare approval reversal, FDA issues a proposal to withdraw Amag Pharmaceuticals Makena because a required postmarket study fai...

Nephron Pharma Warned on Email Unapproved Use

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FDA issues Nephron Pharmaceuticals the first Warning Letter citing a prescription drug manufacturer for promoting its product for ...

CDER Sees Generic Equality in a Levothyroxine Study

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A new CDER investigation of real-world evidence confirms that patients taking levothyroxine benefit equally from generic and brand...

Senseonics PMA Supplement on Glucose Monitor

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Senseonics Holdings files a PMA supplement seeking to extend the wearable life of the Eversense Continuous Glucose Monitoring Syst...

Guide on Opioid Use Disorder Clinical Endpoints

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Federal Register notice: FDA makes available a final guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiven...