A top FDA official has proposed broad changes to the review and approval process for vaccines, citing a new internal review linking the deaths of 10 children to COVID-19 vaccines. In an internal memo ...

The FDA’s decision to revise its vaccine approval process highlights ongoing concerns and debates surrounding vaccine safety ...

Kaiser Health News interviewed Robert Califf, MD, former FDA commissioner, concerning his thoughts on the drug approval process and the current presidential administration’s outlook on quickening ...

Richard Pazdur, the new director of the Center for Drug Evaluation and Research, raised concerns amid the rollout of several ...

The FDA plans to establish the Office of Drug Evaluation Science to improve and modernize the review process for new medications, according to STAT. The new office will help develop a standardized ...

Drug approval is unequivocally the linchpin to any drug development effort and, given the role of the US market in the global marketplace, the drug approval standard employed by FDA remains ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

Health Canada is proceeding with plans to add more flexibility to processes for approving medical treatments through an approach known as "agile licensing." The plans have raised hopes for speedier ...