by Pill Pals | Mar 7, 2025 | News
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: National Institute of Infectious Diseases, Tokyo, Japan (A. Matsuu, K....
by Pill Pals | Mar 7, 2025 | News
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs...
by Pill Pals | Mar 7, 2025 | News
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Author affiliation: Centers for Disease Control and Prevention, Atlanta, Georgia, USA (P.N.Q....
by Pill Pals | Mar 7, 2025 | News
Section 807 of the FDA Reauthorization Act of 2017 (FDARA) requires the FDA to report on certain abbreviated new drug applications (ANDAs) subject to priority review under section 505(j)(11) of the Federal Food, Drug, and Cosmetic (FD&C) Act and certain ANDAs...
by Pill Pals | Mar 7, 2025 | News
Disclaimer: Early release articles are not considered as final versions. Any changes will be reflected in the online version in the month the article is officially released. Min Z. Levine , Feng Liu, Natasha Bagdasarian, Crystal Holiday, Stacie Jefferson, Zhu-nan Li,...
by Pill Pals | Mar 7, 2025 | News
What is the RDRC Program?The Radioactive Drug Research Committee (RDRC) program began when the Food and Drug Administration published a Federal Register notice on July 25, 1975 classifying all radioactive drugs as either new drugs requiring an Investigational New Drug...