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tag fda regulation clinical trials industry

Pandemic Accelerates Trend Toward Remote Clinical Trials
Jef Akst | May 1, 2021 | 8 min read
Now more than ever before, recruiting patients for a research study doesn’t have to mean getting them to leave their homes.
Picking Up the Pace
Kate Yandell | Jan 1, 2016 | 10 min read
FDA designations promise to expedite the approval of drugs for conditions ranging from infectious disease to cancer.
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.
 
Open orange pill bottle with rounded white pills
What’s the Evidence for Fluvoxamine in COVID-19? 
Catherine Offord | May 20, 2022 | 7 min read
The US FDA’s decision not to grant an emergency use authorization for the antidepressant as a COVID-19 treatment highlights a lack of consensus among researchers about how to interpret clinical data on the drug.
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.
Stem Cell Lines Not Fit for Clinic
Kerry Grens | Feb 6, 2014 | 3 min read
Most stem cell lines registered with the NIH don’t comply with the FDA’s guidelines for human use, according to a new report.  
april 2019 editorial the scientist
Miracle Elixirs
Bob Grant | Apr 1, 2019 | 3 min read
A long way into the quest to vanquish cancer, our ears strain to hear the words, “Cancer is cured”—a yearning that can cloud our judgment.
The Tribulations of Clinical Trials
Susan Warner | Apr 25, 2004 | 10+ min read
PictureQuestA plain tablet in a no-name blisterpack. It could save a life.Or maybe not.Since 1994, the Food and Drug Administration has approved year-to-year increases in the number of new candidate drugs for human testing in the United States, rising from 3,350 in 1996 to 3,900 in 2002.1 But the number of drugs that successfully negotiate the trial process and ultimately receive FDA approval is frustratingly low. Despite pharmaceutical companies' and the National Institutes of Health's research
FDA Gives Nod to Melanoma Drug
Jef Akst | Sep 8, 2014 | 2 min read
The US Food and Drug Administration last week approved the first of a new type of immunotherapy that aims to pit a patient’s own immune system against her cancer.
Clinic Trial Problems Kept Mum
Kerry Grens | Feb 11, 2015 | 1 min read
Despite documented dysfunction in a number of studies, rarely do those problems get a mention in the resulting publications, according to a new study.

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