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A pregnant woman gets her blood pressure checked by a doctor
U.K. Health Authority Investigates Epilepsy Drug’s Link to Autism
The Medicines and Healthcare products Regulatory Agency’s investigation comes after a study showed prenatal exposure to topiramate roughly triples a child’s likelihood of having autism or intellectual disability.
U.K. Health Authority Investigates Epilepsy Drug’s Link to Autism
U.K. Health Authority Investigates Epilepsy Drug’s Link to Autism

The Medicines and Healthcare products Regulatory Agency’s investigation comes after a study showed prenatal exposure to topiramate roughly triples a child’s likelihood of having autism or intellectual disability.

The Medicines and Healthcare products Regulatory Agency’s investigation comes after a study showed prenatal exposure to topiramate roughly triples a child’s likelihood of having autism or intellectual disability.

regulation

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.
Updated July 27
Magnifying glass in front of a stack of files of papers
PLOS ONE Pulls Five Papers Tied to Alzheimer’s Drug Controversy
Jef Akst | Mar 31, 2022 | 2 min read
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.
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.
sign reading "bio-security precautions, no unauthorized personnel"
Opinion: Coronavirus and Regulating Access to High-Risk Pathogens
Michael Parker, Shreya Kalra, and Bryce Kassalow | Feb 10, 2022 | 10+ min read
Overbearing restrictions on research into toxins and pathogens such as SARS-CoV-2 could undermine public health and security in the long run.
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.
Updated Mar 8
A healthcare worker holds up three syringes with clear medicine
To Booster or Not: Scientists and Regulators Debate
Jef Akst | Sep 16, 2021 | 7 min read
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.
A stamp with a checkmark and the word FDA approved lying on its side on a white background.
Biogen Defends Newly Approved Alzheimer’s Drug
Jef Akst | Jul 27, 2021 | 3 min read
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.
photo of a researcher looking in a microscope fertilising an egg via intracytoplasmic sperm injection.
Human Stem Cell Research Guidelines Updated
Ruth Williams | May 26, 2021 | 5 min read
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.
marijuana in a petri dish on a blue background with the chemical structure of THC
DEA Moves Toward Approving More Research Marijuana Growers
Shawna Williams | May 19, 2021 | 2 min read
A regulatory change initiated during the Obama administration appears set to be put into practice, allowing more than one supplier of cannabis research products.
Pain Researcher Quits Academia, Takes Lab Home with Him
Jef Akst | May 1, 2021 | 6 min read
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.
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.
Blood Clots a Very Rare Side Effect of AstraZeneca Vaccine: EMA
Catherine Offord | Apr 8, 2021 | 2 min read
The European Medicines Agency emphasizes that the benefits of the jab in protecting against COVID-19 still far outweigh the risks.
Science with Borders: Researchers Navigate Red Tape
Max Kozlov | Mar 1, 2021 | 10 min read
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.
EPA, Environmental Protection Agency, Pollution, science, legislation, environment, Joe Biden, Trumpule, censored science, transparency rule,
A Federal Judge Ditches EPA’s Science Transparency Rule
Asher Jones | Feb 8, 2021 | 2 min read
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.
Opinion: Europe Is Sinking Biotech—Again
Robert Paarlberg | Feb 1, 2021 | 3 min read
Scientifically groundless regulations could undercut the potential of gene-edited crops, much as they have with GMOs.
Opinion: Emergency Use Authorizations Are a Threat to Science 
Kevin J. Tracey and Christina Brennan | Dec 1, 2020 | 4 min read
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.
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.
Panel Lays Out Guidelines for CRISPR-Edited Human Embryos
Lisa Winter | Sep 4, 2020 | 2 min read
The International Commission on the Clinical Use of Human Germline Genome Editing claims the technology is still too risky for therapeutic use.
Variation in Cannabis Testing Challenges a Young Industry
Katarina Zimmer | Mar 1, 2020 | 10 min read
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.
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