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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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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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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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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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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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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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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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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