The agency discusses its response to COVID-19 and other milestones in its year-end review.
FDA has published its review of the accomplishments the agency achieved in 2021. FDA 2021 Year in Review–Working for You details the agency’s response to COVID-19, including vaccine, treatment, and testing authorizations. FDA has also been monitoring variants of the virus and issuing guidance and contingency plans for dealing with the pandemic. The report also discusses the agency’s efforts for addressing the misuse of prescription drugs, the problem of fraudulent medicines, and the advancement of generic drugs and biosimilars, as well as its work in food safety and tobacco products.
“While much of the attention the agency received in 2021 focused on our response to the pandemic, I am pleased to note that, despite a great deal of uncertainty, the agency was able to accomplish a wide range of its priorities that are already protecting the health and well-being of millions of people living in the US,” said Acting Commissioner Janet Woodcock, MD, in the report. “Every year the FDA reviews hundreds of product applications, ultimately determining which drugs, devices, or biological products (e.g., vaccines) will be marketed in the US. The process involved is rigorous, thoughtful and always adheres to standards for safety and effectiveness. We help to ensure that the human and animal food supply is safe, sanitary, and accurately labeled, and that cosmetic products are safe and properly labeled,” said Woodcock.
Source: FDA
Guidance on Quality Culture Standards
June 3rd 2025Matt Cushing, VP of Quality and Science, Nelson Labs, and Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, discuss PDA/ANSI Standard 06-2025: Assessment of Quality Culture Guidance Documents, Models, and Tools, which was published in February 2025.