HomeRegulation
Regulation
FDA stalls again on ban proposal for hair product chemicals
The US Food and Drug Administration’s proposal to ban formaldehyde in haircare products has been pushed back once again, from July to September, and...
Warning over combining warfarin and tramadol
After the recent death of a patient who had been taking warfarin and tramadol together, British health authorities have issued an alert on using...
UK flags risks of epilepsy drug during pregnancy
After a major safety review triggered by a recent study in Europe, Britain’s Medicines and Healthcare Products Regulatory Agency (MRHA) has prohibited the dispensing of migraine...
FDA says no to ecstasy for PTSD treatment
US Food and Drug Administration advisers have voted against a therapy based on the mind-altering drug MDMA, known as “ecstasy”, for patients with post-traumatic...
EMA suspends preterm birth drugs over possible cancer risk
The European Medicine Agency’s safety committee has recommended the suspension of the marketing authorisations for medicines containing 17-hydroxyprogesterone caproate (17-OHPC) in the European Union, after reviews...
FDA aims to reduce toxicity, boost efficiency, of cancer drugs
With evidence that thousands of cancer patients become so ill from their treatment that they skip their dosage or stop taking it altogether –...
FDA heart pump recall after link to deaths and injuries
A pair of heart devices linked to hundreds of injuries and at least 14 deaths has received the FDA’s most serious recall, the agency announced...
CMS seeks to place Netcare scheme under curatorship
In yet another clash with the healthcare industry, and following recent accusations of hostility and harassment, the Council for Medical Schemes (CMS) has applied...
FDA’s plan to ban hair relaxer chemical 'far too late'
A dozen years after a federal agency classified formaldehyde as a human carcinogen, the US Food and Drug Administration (FDA) is tentatively scheduled – in April...
Deaths and lawsuits expose flaws in FDA’s medical device oversight
A slew of lawsuits in the US – resulting from patients’ deaths – has highlighted the potential risks of various medical devices, most of...
SA inches towards finalisation of food label regulations
The goalposts are almost in sight (relatively speaking), after several years of extensive research and processes aimed at slashing South Africa’s obesity, diabetes and...
New UK rules for treatment with acne drug
Britain’s health watchdog, the Medicines and Healthcare Products Regulatory Agency (MHRA), has announced a series of regulatory changes to strengthen the safe use of...
Suncreens containing toxins still available on shelves despite warnings
Despite warnings and safely concerns expressed by the US Food and Drug Administration (FDA) four years ago about dangerous ingredients in sunscreens, some of...
FDA approves Japan’s Alzheimer’s agitation drug
The first approved drug for agitation in Alzheimer’s patients has been approved by the US Food and Drug Administration, with Otsuka Pharmaceuticals’ brexpiprazole being...
Self-harm risk high immediately after starting antidepressants – US analysis
Patients who take antidepressants are at highest risk of self-harm in the weeks immediately after the drug is prescribed, an analysis of more than...
New, stricter rules for food labelling
Major changes are in store for how food items are labelled in South Africa, with the Department of Health having gazetted proposed recommendations in...
Why Africa urgently needs a continental medicines regulator
In most African countries, regulatory failures are a result of long-standing, well-recognised challenges facing individual medicines regulatory agencies across the continent.
The limitations may be...