Clinical Research Solutions
April 22, 2022 EMA’s human medicines committee (CHMP) has given a recommendation for two diabetes mellitus treatments, Actrapid and Insulatard, for use outside the European Union (EU). EMA is...
Clinical Research Solutions
FDA issued a final guidance to drug sponsors on conducting and submitting bioavailability (BA) studies for drug products in investigational new drug applications (INDs), new drug applications (NDAs),...
Clinical Research Solutions
On April 13, 2022, FDA published a new draft guidance for industry entitled “Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic...
Clinical Research Solutions
Today, the U.S. Food and Drug Administration issued a new draft guidance to industry for developing plans to enroll more participants from underrepresented racial and ethnic populations in the U.S....
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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...
Clinical Research Solutions
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....
Clinical Research Solutions
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...
Clinical Research Solutions
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...