Drugs

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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