As agency observers wonder whether and how political considerations will impact the timing of a COVID-19 vaccine approval or authorization, the Pink Sheet looks at instances through the years where agency staffers found themselves operating under precedents with which they disagreed or that didn’t work out as expected.

Starpharma has received approval for its innovative VivaGel condom in Japan, which will be launched in the first half of 2019 by Okamoto Industries. 

Five device-related close-out letters were released by US FDA in July.

Complete list of 103 domestic and 66 foreign device quality-related warning letters released in 2012.