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Agency Alerts

October 5, 2021 Agency Alerts

FDA Announces All-Time Low User Fee Rates for Priority Review...

On Thursday, September 30th, FDA announced its user fee rates for fiscal…

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September 29, 2021 Agency Alerts

EMA Takes Steps to Minimize Animal Testing During Product Development

On Wednesday, September 29th, EMA announced the implementation of new measures indented…

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April 15, 2020 Agency Alerts

FDA Issues Product-Specific Guidance Documents for Chloroquine Phosphate and Hydroxychloroquine...

On Tuesday, April 14th, FDA released two product-specific guidance documents for chloroquine…

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April 6, 2020 Agency Alerts

FDA Requests all Zantac (Ranitidine) Products be Removed from the...

On Wednesday, April 1, 2020, FDA issued a statement asking all companies…

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August 22, 2019 Agency Alerts

Only 12% of Generic Drugs Reviewed Were Approved in the...

On August 7th, the U.S. Government Accountability Office (GAO) published its report…

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July 22, 2019 Agency Alerts

FDA Finalizes Guidance Concerning Premarket Tobacco Product Applications for E-Cigarettes

On, Tuesday, June 11th, 2019, the FDA issued a final guidance document…

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July 11, 2019 Agency Alerts

Improvements Are Coming to the Inactive Ingredient Database (IID)

In a new draft guidance released by the FDA on July 11th,…

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March 15, 2019 Agency Alerts

FDA Announces Update to Nonproprietary Naming Convention for Biosimilar Products

On Thursday, March 7th, FDA published a revised draft guidance, updating its…

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