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FDA Roundup: August 1, 2023
… violated the 2010 injunction and scheduled an evidentiary hearing regarding whether their noncompliance was justified. Prior to the hearing, the parties negotiated the consent decree, which, …
Coronavirus (COVID-19) Update: Daily Roundup September 23, 2020
… Committee on Health, Education, Labor and Pensions at a hearing entitled, “ COVID-19: An Update on the Federal …
FDA to Hold Advisory Committee Meetings to Discuss Emergency Use Authorization for Booster Doses and COVID-19 Vaccines for Younger Children
… of the manufacturers’ data. There will be an open public hearing each day during which the public will be given an …
Statement from Sarah Yim, M.D., acting director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, on FDA’s continued progress facilitating competition in the biologic marketplace with approval of 25th biosimilar product
… in safety and effectiveness. The FDA held a public hearing on the development of biosimilar and interchangeable …
FDA and CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine Use Following Thorough Safety Review
… Practices met today to discuss the latest data on TTS, hearing from the vaccine manufacturer Janssen and the …
FDA Roundup: December 15, 2023
… decreased neutrophils, increased ALT, increased AST, hearing loss, skin infection, and urinary tract infection. …