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Instructions for Use — Patient Labeling for Human Prescription Drug a

by Pill Pals | Mar 7, 2025 | News

Docket Number: FDA-2019-D-1615 Issued by: Guidance Issuing Office Center for Biologics Evaluation and Research Center for Drug Evaluation and Research Office of the Commissioner, Office of the Chief Medical Officer, Office of Combination Products This guidance...

FDA Roundup: March 7, 2025

by Pill Pals | Mar 7, 2025 | News

For Immediate Release: March 07, 2025 Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:On Wednesday, the FDA approved Encelto (revakinagene taroretcel-lwey), an allogeneic encapsulated cell-based gene...

Oz Virus Infection in 6 Animal Species, Including Macaques, Bears, and Companion Animals, Japan

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....

FDARA Title VIII Sections 807 and 805

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...

Antiviral Susceptibility of Influenza A(H5N1) Clade 2.3.2.1c and 2.3.4.4b Viruses from Humans, 2023–2024

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....

FY 2024 FDARA Title VIII Section 807 and 805 Report

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...