The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
In a new FDA Voices entitled, The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health, agency leaders explain that they are committed to making decisions that are guided by science and data regarding the authorization or approval of COVID-19 vaccines.
FDA issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” to help drug and biological product manufacturers (including animal drug manufacturers) transition from operations impacted by the COVID-19 public health emergency to normal manufacturing operations. This guidance provides recommendations to help manufacturers prioritize products and activities as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply. The guidance for industry “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products” describes high-level considerations for resuming normal operations. This temporary guidance, however, provides more detailed considerations and is specific to the COVID-19 public health emergency.
Testing updates:
As of today, 247 tests are authorized by FDA under EUAs; these include 197 molecular tests, 46 antibody tests, and 4 antigen tests.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:
In a new FDA Voices entitled, The FDA’s Scientific and Regulatory Oversight of Vaccines is Vital to Public Health, agency leaders explain that they are committed to making decisions that are guided by science and data regarding the authorization or approval of COVID-19 vaccines. FDA issued a temporary guidance, “Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency,” to help drug and biological product manufacturers (including animal drug manufacturers) transition from operations impacted by the COVID-19 public health emergency to normal manufacturing operations. This guidance provides recommendations to help manufacturers prioritize products and activities as they resume normal operations and as they remediate current good manufacturing practice (CGMP) activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply. The guidance for industry “Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products” describes high-level considerations for resuming normal operations. This temporary guidance, however, provides more detailed considerations and is specific to the COVID-19 public health emergency. Testing updates: As of today, 247 tests are authorized by FDA under EUAs; these include 197 molecular tests, 46 antibody tests, and 4 antigen tests. The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.