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Federal Register notice: FDA makes available a draft guidance entitled Electromagnetic Compatibility of Medical Devices.

BsUFA 3 Public Meeting Looking at New Proposals

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CDER Office of Therapeutic Biologics and Biosimilars director Sarah Yim previews issues likely to be raised at an 11/19 Biosimilar...

ASCA Pilot Program Explained

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CDRH senior policy analyst Stacy Cho describes in a Webinar the thinking behind the Accreditation Scheme for Conformity Assessment...

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...

2nd Complete Response Letter on Adamis Zimhi

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FDA issues Adamis Pharmaceuticals a second complete response letter on its NDA for Zimhi, a high-dose naloxone injection product f...

Draft Guide on Device Electromagnetic Compatibility

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FDA makes available a draft guidance entitled Electromagnetic Compatibility (EMC) of Medical Devices.

Guide on eFiles for Animal Drug Applications

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Federal Register notice: FDA makes available a final guidance #197 entitled Documenting Electronic Data Files and Statistical Anal...