Drugs

FDA Updates Drug Reporting Requirements

FDA Updates Drug Reporting Requirements

On February 5, 2024, FDA issued a final guidance regarding reporting by drug establishments for listed drug and biological products manufactured, prepared, propagated, compounded, or processed for commercial distribution. The upshot is that drugs listed with FDA must...

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FDA Registration Renewal Season Opens Oct 1, 2023

FDA Registration Renewal Season Opens Oct 1, 2023

Between October 1 and December 31, Food and Drug Administration (FDA)-registered facilities must renew their registrations. Our team has handled registration renewals for thousands of facilities. Here are some things you need to know to ensure your renewal is...

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CDER Issues Warning Letter on Drug Product Listing

CDER Issues Warning Letter on Drug Product Listing

On May 23, 2022, the Food and Drug Administration’s (FDA) Center for Drug Evaluation & Research (CDER) issued a public warning letter to Grimann S.A. de C.V. concerning contradictory information between their product labeling and their electronic drug product...

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FDA Announces New and Updated Drug and Medical Device User Fees

FDA Announces New and Updated Drug and Medical Device User Fees

UPDATE 12/30/2020: FDA publishes new OTC drug user fees, read more here. Original Post 08/27/2020: FDA has officially announced the updated drug and medical device fees for the 2021 fiscal year (October 1, 2020 – September 30, 2021). This includes fees associated with...

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