Dec 19, 2022 FDA Denies Requests for Revocation of EUA for Covid Vaccine for Use in Individuals 5-11 and 12-17 Years of Age By Melissa Gilmore Jarred Reiling Keo Shaw The FDA has denied two citizen petitions filed on behalf of the Informed Consent Action Network (ICAN) requesting the agency revoke its...
Dec 08, 2022 Poland - Life Sciences Monthly Brief, November 2022 By Andrzej Balicki, Ph.D. Jolanta Dabrowicz Przemysław Matuszewski Urszula Grębowska +1 more... Show less We first wrote about the planned amendments to the Pharmaceutical Law and certain other acts (the so-called Verticalisation Act) in...
Dec 01, 2022 FDA publishes draft guidance on active ingredient sameness in proposed generic drugs and their reference listed drugs By Christine Lentz The FDA recently published “Sameness Evaluations in an ANDA – Active Ingredients,” a new draft guidance detailing recommendations for...