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Safety-Related Labeling Changes Posted

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FDA posts new drug safety-related labeling changes for five biologics.

Multiple Violations at Family Pharmacy of Statesville

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FDA warns Family Pharmacy of Statesville, NC, about multiple drug compounding violations.

Certificates of Confidentiality Final Guidance

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FDA issues a final guidance on Certificates of Confidentiality, which describes the agencys implementation of revised provisions u...

FDA Complete Response Letter for Alkermes Psych Drug

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Alkermes says it is working with FDA on issues raised in an agency complete response letter for the firms NDA for ALKS 3831 to tre...

Bob Temple on Covid Impact on Meetings With Industry

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CDER deputy Center director for clinical science Bob Temple opines on meetings with industry on product development issues that ma...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include Family Pharmacy and Quten Research Institute.

Draft Guide on Device Electromagnetic Compatibility

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Federal Register notice: FDA makes available a draft guidance entitled Electromagnetic Compatibility of Medical Devices.

Bill Introduced to Reduce Animal Testing

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Three congressmen introduce the Alternatives to Animals for Regulatory Fairness Act to reduce animal testing by drug companies.

Moderna Covid Vaccine 95% Efficacy: Interim Analysis

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Moderna says its investigational Covid-19 vaccine is showing a 94.5% efficacy rate based on a NIH-appointed data safety monitoring...

FDA Adds 1,000 New Employees During FY 2020

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FDA commissioner Stephen Hahn says the agency has added about 1,000 new staff in fiscal year 2020 due to a streamlined hiring spre...