User:BD2412/Vaccine law resources/Regulation
- Process for Publishing Emergency Use Authorizations for Medical Devices During Coronavirus Disease 2019, 85 FR 33685 (June 2, 2020)
- Third Amendment to Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19, 85 FR 52136 (August 24, 2020)
- Countermeasures Injury Compensation Program: Smallpox Countermeasures Injury Table, 85 FR 65311 (October 15, 2020)
- Vaccines and Related Biological Products Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments, 85 FR 76082 (November 27, 2020)
- Fourth Amendment to the Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19 and Republication of the Declaration, 85 FR 79190 (December 9, 2020)
- Elizabeth K. Conti, Joanne S. Hawana, FDA Ups the Ante and Sends First Notice of Noncompliance for Failure to Submit Clinical Trial Results (May 06, 2021)
VRBPAC
[edit]The Committee reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases, and, as required, any other products for which the Food and Drug Administration has regulatory responsibility. The Committee also considers the quality and relevance of FDA's research program which provides scientific support for the regulation of these products and makes appropriate recommendations to the Commissioner of Food and Drugs.
Aborted fetal tissue
[edit]- Matthew Schneider, If Any Drug Tested on HEK-293 Is Immoral, Goodbye Modern Medicine, Through Catholic Lenses via Patheos (January 28, 2021)