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March 30, 2022
March 29, 2022 Today, the U.S. Food and Drug Administration authorized a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 vaccines for older people and certain...
March 22, 2022
The U.S. Food and Drug Administration today issued the guidance for industry, Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4. This guidance provides information to...
March 15, 2022
Monday, March 14, 2022 Today, the U.S. Food and Drug Administration announced the rates for over-the-counter (OTC) monograph drug user fees for fiscal year (FY) 2022 in a Federal Register Notice...
November 5, 2021
On Friday, October 29, 2021, the EMA published a statement providing marketing authorization holders (MAHs) recommended submission dates for 2021 variations in order to meet the regulatory deadlines....
October 28, 2021
On Wednesday, October 27th, FDA revoked Life Technologies Corporation’s Emergency Use Authorization (EUA) for its TaqPath COVID-19 MS2 Combo Kit 2.0. Background On August 2, 2021, FDA issued an EUA...
October 6, 2021
On Thursday, September 30th, FDA announced its user fee rates for fiscal year 2022 for Sponsors using the priority review vouchers (PRVs) for the following: Tropical diseases Material threat medical...
September 30, 2021
On Wednesday, September 29th, EMA announced the implementation of new measures indented to replace, reduce, and refine animal use in the development, manufacturing, and testing of human and...
April 15, 2020
On Tuesday, April 14th, FDA released two product-specific guidance documents for chloroquine phosphate tablets and hydroxychloroquine sulfate tablets, two drugs being investigated as potential...
April 6, 2020
On Wednesday, April 1, 2020, FDA issued a statement asking all companies to stop selling all forms of Zantac (ranitidine). Background On Friday, September 13, 2019, the FDA announced that “some...