Human Infection with Avian Influenza A(H10N3) Virus, China, 2024
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: Guangxi Center for Disease Prevention and Control, Nanning, China (J....Guidance for Industry
Docket Number: FDA-2022-D-0108 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Considerations for Waiver Requests for...FDA approves first interchangeable biosimilar to Perjeta to treat cert
ActionFDA approved Poherdy (pertuzumab-dpzb) injection as an interchangeable biosimilar biological product to Perjeta (pertuzumab). Poherdy (pertuzumab-dpzb) is the first biosimilar approved for Perjeta (pertuzumab).Poherdy is approved for the following treatment...CDER Electronic Submissions Presentations
AAM GRx+Biosims, North Bethesda, MDOctober 28, 2025FDA Electronic Submissions (EXPO BOOTH) – Jonathan Resnick, Heather Crandall, Seyoum Senay, Megan Boals, Sajid Khan, Office of Business Informatics, CDERAAM GRx+Biosims, North Bethesda, MDOctober 21, 2024eCTD v4...FDA Encourages Public to Follow Established Choking Rescue Protocols
Español 简体中文 (Simplified Chinese) Tagalog Update: November 13, 2025The FDA has taken actions to address the marketing of unauthorized anti-choking devices, including issuing Warning Letters and an Import Alert. Additional information is provided below under the FDA...All Drug Purchases Are
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