Stephen Hahn

Industry group says FDA botched COVID-19 convalescent plasma guidance

Already under fire for what some view as a premature authorisation of convalescent plasma for COVID-19, the FDA is now being accused of a blunder that could render current supplies unusable. Bioindustry association MichBio says the FDA’s labelling requirements for COVID-19 convalescent plasma (CCP) – which were published alongside the emergency use authorisation – could …

Industry group says FDA botched COVID-19 convalescent plasma guidance Read More »

Stephen Hahn and the terrible, horrible, no good, very bad FDA weekend

The FDA commissioner took to Twitter Monday night to defend his performance at the agency, which came under sharp criticism amid accusations that the authorization of a plasma treatment for Covid-19 was politically motivated and that he stood by while President Trump unfairly maligned FDA staffers, prompting calls for his resignation.

Trump launches baseless attack on FDA; agency controversially authorizes plasma treatment for Covid-19

Over the weekend, Trump called the agency, without evidence, part of a “deep state” that was slow-walking vaccines and drugs for Covid-19. The next day, the agency authorized convalescent plasma despite having turned it down shortly before due to insufficient evidence.

FDA guidance eases some Covid-19 vaccine concerns, but others remain

Amid fears of a premature emergency use authorization for a Covid-19 vaccine granted for political reasons, the guidance that the FDA released at the beginning of the month sets much tougher standards. But trial enrollment, anti-vaccine sentiment and other potential problems persist.