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Agency Alerts

November 5, 2021 Agency Alerts

EMA to Marketing Authorization Holders (MAHs): Submit Type I Variations...

On Friday, October 29, 2021, the EMA published a statement providing marketing…

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October 28, 2021 Agency Alerts

FDA Revokes Emergency Use Authorization of IVD Device for COVID-19...

On Wednesday, October 27th, FDA revoked Life Technologies Corporation’s Emergency Use Authorization…

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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 Zantac Products be Removed from the Market

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 on Premarket Tobacco Product Applications for E-Cigarettes

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

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