4 ms·

Can you prove your statement by providing an example please?

• frockington1 5y ago
  Tuskegee Syphilis Trials
• zuminator 5y ago
  Remdesivir [0], for one, which received Fast Track and Priority Review designation from the FDA. It was also noted in a 2019 Wall Street Journal article [1] that the majority of new drug approvals are now done through a Fast Track process. [0] https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-covid-19 https://www.fda.gov/news-events/press-announcements/fda-appr... [1] https://www.wsj.com/articles/fast-track-drug-approval-designed-for-emergencies-is-now-routine-11562337924 https://www.wsj.com/articles/fast-track-drug-approval-design...
• pgalvin 5y ago
  Sure. Garasdil was approved by the FDA in 2006 and, as this press release shows [0], continued running studies into it as a condition of the approval. They conceded that full results could not be available before approval; “While the study period was not long enough for cervical cancer to develop, the prevention of these cervical precancerous lesions is believed highly likely to result in the prevention of those cancers.” From what I can gather, the Phase III study participants continued to receive follow-up checks for at least a decade. [0]https://web.archive.org/web/20091019080918/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2006/ucm108666.htm https://web.archive.org/web/20091019080918/https://www.fda.g...
• StephenAmar 5y ago
  Please actually look at the change history in https://clinicaltrials.gov/ct2/history/NCT04368728 https://clinicaltrials.gov/ct2/history/NCT04368728 The completion date was changed multiple times since April 2020 and they clearly appended booster trials to the existing trials and pushed back the dates. It truly is that simple.