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Opinion: Emergency Use Authorizations Are a Threat to Science
Opinion: Emergency Use Authorizations Are a Threat to Science
As COVID-19 therapies get emergency-use green lights, the Biden administration must organize a therapeutic review board to help identify what’s working and what’s not.
As COVID-19 therapies get emergency-use green lights, the Biden administration must organize a therapeutic review board to help identify what’s working and what’s not.
FDA, regulation, clinical trials
A Challenge Trial for COVID-19 Would Not Be the First of Its Kind
Jef Akst | Oct 8, 2020 | 9 min read
Although scientists debate the ethics of deliberately infecting volunteers with SARS-CoV-2, plenty of consenting participants have been exposed to all sorts of pathogens in prior trials.
Judge Rules Unreported Clinical Trial Data Must Be Made Public
Amy Schleunes | Feb 26, 2020 | 2 min read
The sponsors of upwards of 1,000 clinical trials may be forced to publish data that have gone unpublished over a 10-year period.
New Automated Tool Monitors Clinical Trial Reporting
Diana Kwon | Feb 21, 2018 | 3 min read
The watchdog website FDAAA TrialsTracker names and shames human studies that breach the FDA’s requirements for reporting results.
Opinion: Improving FDA Evaluations Without Jeopardizing Safety and Efficacy
John D. Loike and Jennifer Miller | Feb 1, 2017 | 4 min read
What can be done to lower development costs and drug prices?
FDA Calls for Data on ALS Drug
Jef Akst | Apr 21, 2015 | 2 min read
In the midst of a debate about an experimental drug’s early approval, the US Food and Drug Administration requests that full trial results be released.
That Loving Feeling
Megan Scudellari | Jul 1, 2014 | 9 min read
There are no FDA-approved drugs to treat low sexual desire in women, but not for lack of trying.
Inconsistent Evidence
Jef Akst | Jan 22, 2014 | 1 min read
More than a third of US drug approvals are based on a single large clinical trial, while others require more in-depth study, according to a new report.