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Sandostatin Not Withdrawn Due to Safety/Efficacy

[ Price : $8.95]

Federal Register notice: FDA determines that Novartis Sandostatin (octreotide acetate) injection was not withdrawn for safety or e...

False Results Warning on 2 Covid Tests

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FDA issues a safety communication warning against using Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurat...

Medical Device Companies Need Closed-Loop Traceability: Column

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Greenlight Guru founder Jon Speer says medical device companies should use a quality management system solution to maintain closed...

OCE Marks National Black Family Cancer Awareness Week

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The FDA Oncology Center of Excellence says it will mark its inaugural National Black Family Cancer Awareness Week 6/17-6/23.

HHS Asks Court to Dismiss Drug Import Suit

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HHS asks the DC federal court to dismiss a stakeholder suit seeking to bar the agency from implementing a Section 804 drug importa...

Moderna Seeking Covid Vaccine Full Approval

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Moderna begins a rolling BLA for its mRNA Covid-19 vaccine for use in individuals 18 years of age and older.

Some OPDP eCTD Submissions Mandatory on 6/24

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FDA posts a notice giving 6/24 as the effective date for certain specified OPDP submissions to be in the eCTD format.

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 5/28/2021.

GAO Weighs in on FDA Inspections Priority

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The U.S. Government Accountability Office says FDA should focus on reducing its inspections backlog, requesting the agencys plans ...

Eton Pharmaceuticals Complete Response on NDA

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