regulation

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.

The retracted studies were coauthored by a scientist who worked on an Alzheimer’s therapy in development by Cassava Sciences, a company reportedly under investigation for providing falsified data to the FDA.

A new regulation and registry covering investigational medicinal products mandates reporting and supports multinational trials.

Overbearing restrictions on research into toxins and pathogens such as SARS-CoV-2 could undermine public health and security in the long run.

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.

President Biden’s planned rollout of additional COVID-19 vaccine doses is set to begin next week, but questions remain about who should get them.

The US Food and Drug Administration has called for a federal investigation of its own regulatory review process after widespread criticism of its decision on Aduhelm.

Removal of the 14-day limit for culturing human embryos is one of the main changes in the revised recommendations from the International Society for Stem Cell Research.

A regulatory change initiated during the Obama administration appears set to be put into practice, allowing more than one supplier of cannabis research products.

After resigning from the University of New England last year, Geoffrey Bove continues to study the effects of massage on rats in a facility he set up in his house.

Now more than ever before, recruiting patients for a research study doesn’t have to mean getting them to leave their homes.

The European Medicines Agency emphasizes that the benefits of the jab in protecting against COVID-19 still far outweigh the risks.

Scientists who work with foreign biological specimens face a patchwork of permits that threaten to block their projects, with potentially harmful consequences for the ecosystems they study.

The Trump-era regulation, which allowed certain studies to be downplayed in the development of environmental regulations, drew sharp criticism from scientists and environmental groups.

Scientifically groundless regulations could undercut the potential of gene-edited crops, much as they have with GMOs.

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.

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.

The International Commission on the Clinical Use of Human Germline Genome Editing claims the technology is still too risky for therapeutic use.

The US lacks standardized methods to assess products for potency and safety. That’s a big problem for the labs tasked with doing the testing.