In The News

October 9, 2020
Bio/pharma industry leaders support FDA’s newly published EUA guidance for COVID-19 vaccine authorization. After a highly publicized dispute over FDA requirements for authorizing a vaccine to…
October 8, 2020
Executive Summary Among hundreds of trials underway on potential therapeutics, only about 6% of study arms are expected to yield actionable data because most are nonrandomized, underpowered or…
October 7, 2020
The White House on Tuesday, after weeks of delay, approved tough new standards for coronavirus vaccines — but only after the Food and Drug Administration unilaterally published the guidelines on its…
October 6, 2020
The Food and Drug Administration laid out updated safety standards Tuesday for makers of COVID-19 vaccines after the White House blocked their formal release, the latest political tug-of-war between…
October 6, 2020
(CNN)A likely contagious President Donald Trump returned to the White House Monday evening, whipped off his mask and filmed a video, heavy on bluster and short on facts, that proclaimed: "The…
October 6, 2020
WASHINGTON (AP) — The White House has blocked new Food and Drug Administration guidelines on bringing potential vaccines for COVID-19 to market that would almost certainly have prevented their…
October 5, 2020
The F.D.A. proposed stricter guidelines for emergency approval of a coronavirus vaccine, but the White House chief of staff objected to provisions that would push approval past Election Day.…
October 2, 2020
Executive Summary US FDA plans to leverage large safety surveillance databases to make up for the fact that a vaccine authorized for emergency use likely would have only one-quarter to one-half as…
October 2, 2020
TRUMP HAS COVID-19: President Donald Trump is in quarantine at the White House after testing positive for coronavirus, a revelation that could upend his presidency and the 2020 election. “Tonight…
October 2, 2020
The eleventh installment of Ropes & Gray's podcast series, Non-binding Guidance, focuses on the current regulatory landscape surrounding the use of real-world evidence in drug development and the…