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tag biobusiness clinical trials fda drug development regulation

Drug Development: Clinical Trials
Sam Jaffe | May 18, 2003 | 3 min read
5-Prime | Drug Development: Clinical Trials Who gets tested in Phase I Trials? As many as 80 healthy or sick human beings. Phase I trials occur after animal tissue and whole-animal studies have determined that the agent appears safe and effective for its intended use. This stage discerns mainly whether the agent is safe for humans and provides data to determine the pharmacological effects. Phase I studies, which last from two to six months, are observed closely so that the entire trial can
Antidepressant Approvals Could Herald New Era in Psychiatric Drugs
Bianca Nogrady | Oct 1, 2019 | 9 min read
The FDA has given the green light to the first major new classes of antidepressant therapies in decades, opening up new avenues for therapeutic development.
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.
Questions Raised About “Breakthrough” Therapies’ Clinical Support
Catherine Offord | Jul 17, 2018 | 2 min read
Compared to other drugs, therapeutics given breakthrough status receive FDA approval on the basis of weaker trial evidence, a study finds.
Doctor holding stethoscope in front of European Union flag
New EU Protocol Aims to Improve Clinical Trial Transparency
Sophie Fessl, PhD | Feb 16, 2022 | 4 min read
A new regulation and registry covering investigational medicinal products mandates reporting and supports multinational trials.
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.
Another Obesity Drug Trial Death
Kerry Grens | Dec 2, 2015 | 2 min read
A second patient taking an experimental medication to treat Prader-Willi Syndrome has died of blood clots.
Lazarus Drugs
Kate Yandell | Feb 1, 2015 | 8 min read
While some drugs sail through development, others suffer setbacks, including FDA rejections, before reaching the market.
 
Several silver foil pill packs with white pills
FDA Authorizes Pfizer’s Paxlovid, First Oral Therapy for COVID-19
Jef Akst | Dec 23, 2021 | 2 min read
Given within three days of symptom onset, the pill combination was nearly 90 percent effective at preventing high-risk patients from developing severe illness in a clinical study.
Research laboratory, no people, clean white, horizontal
Making Sense of Regulations
Cytiva | Feb 23, 2023 | 3 min read
Knowing what to focus on, what resources are available, and who to talk to for regulatory advice ahead of time can smooth the drug discovery journey.

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