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FDA Debars Former Insys Sales Manager

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Federal Register notice: FDA issues an order to permanently debar former Insys Therapeutics regional sales manager Alec Burlakoff.

Drug Distributor Owner Debarred by FDA

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Federal Register notice: FDA issues an order to permanently debarring former Cumberland Distribution owner Jerrod Nichols Smith fr...

Guide on INDs for Antisense Oligonucleotide Drugs

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Federal Register notice: FDA makes available a draft guidance entitled IND Submissions for Individualized Antisense Oligonucleotid...

Nostrum Labs Recalls Metformin Lot

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Nostrum Laboratories recalls one lot of metformin HCl extended release tablets after it was determined to contain levels of nitros...

Stokes Healthcare FDA-483

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FDA releases an FDA-483 with four observations from an inspection at the Stokes Healthcare outsourcing facility.

Advancing New Alternative Methodologies Report

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FDA issues a report on steps it has taken to integrate alternative approaches into regulatory programs.

Mouse Embryo Assay for Reproduction Tech Devices Guide

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Federal Register notice: FDA posts final guidance entitled Mouse Embryo Assay for Assisted Reproduction Technology Devices.

Alert on Covid Test False Negatives

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FDA issues a safety alert about false negatives with KorvaLabs Curative SARS-Cov-2 (Covid-19) test.

No Evidence Supporting Covid Vaccine Dosing Changes: FDA

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FDA commissioner Stephen Hahn and CBER director Peter Marks strongly urge healthcare providers not to unilaterally alter the FDA-a...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Cocos Holistic Specialties & Apothecary and Reddy Naturals.