The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...
For certain monospecific antibodies, three-month toxicology studies plus other supportive evidence will suffice, eliminating ...
The FDA estimates that a typical non-clinical programme with a monoclonal antibody product could include more than 100 NHPs, ...
Experts can't agree on whether to use COVID-19 antibody tests to check whether people need a booster shot. The FDA said on May 19 that antibody tests shouldn't be used to test for COVID-19 immunity.
On , The US Food and Drug Administration issued draft guidance identifying specific types of monoclonal antibody products for which the agency believes six-month toxicity testing in non-human primates ...
People would like to know whether their COVID-19 vaccine is protective enough or a previous infection will keep them safe. Experts warned that taking an antibody test isn’t a good way to find out. The ...
The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical ...
As the COVID-19 pandemic continues to grow around the nation, the University of Arizona is taking drastic steps in order to increase testing and keep Arizona’s general public as safe as possible. The ...
The FDA has issued emergency authorizations to 12 antibody tests for the virus. As federal officials gradually begin reopening the country, expanded testing is central to the conversation. Until now, ...
After fighting against animal testing for decades with little success, campaigners now see a real prospect of rapidly ...
If you are looking for a single magical number to tell whether you can be more lax on Covid-19 precautions, sorry, but the level of antibodies in your blood is not going to provide it. Antibodies aren ...