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Regulatory
Council bans vape sales in pharmacies
Pharmacies are banned from selling vapes as aids to quit smoking, the SA Pharmacy Council registrar Vincent Tlale said, with the products now added...
Experts, FDA flag synthetic chemicals in new vapes
Independent researchers as well as the FDA have sounded the alarm over nicotine alternatives used in vapes being launched in the US and abroad,...
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...
UK safety updates for topical steroids
British health authorities have issued a drug safety update saying that while topical steroid products are safe and highly effective treatments for managing various...
Surrogacy group fails in bid to declare regulations unconstitutional
A bid to declare regulations under the National Health Act relating to the control over artificial fertilisation, embryo transfer, storage and destroying of zygotes...
Justice yet to be served in US osteoporosis drug case
A US court case by 1 000 plaintiffs against pharmaceutical company Merck has been dragging on since 2011, writes Gregory Curfman in JAMA Network,...
New SAHPRA guidelines planned to address codeine abuse
South Africa’s medicines regulator is developing a new set of initiatives to stem the misuse of codeine, found in certain pain relief medicines and...
Asthma drug warning stepped up after 500 children react
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) says more prominent warnings would be added to the information provided on boxes of the asthma...
FDA accelerated approval for Duchenne drug questioned
The decision by the US Food and Drug Administration to grant accelerated approval for gene therapy to treat Duchenne muscular dystrophy, and which includes...
Clicks pharmacy dispute resolution imminent
The resolution of the restructure of the Clicks private-label medicine business with the Department of Health is imminent, the company has suggested, with analysts...
FDA approves new UTI treatment
The US Food and Drug Administration has approved Pivya (pivmecillinam) tablets for to treat uncomplicated urinary tract infections (UTIs), caused by susceptible isolates of...
UK issues side effect alert for men on hair loss, prostate drug
Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) will introduce a patient alert card to boost awareness among men taking finasteride, warning about potential...
NICE approves drug combo for young brain cancer patients
British children and teenagers with an aggressive form of brain cancer may benefit after a new life-extending drug combination was recommended for NHS use...
One-year reprieve for low-cost health insurers
An 11th hour reprieve has been granted by the Council for Medical Schemes (CMS) to insurers offering cheap primary healthcare cover, giving them another...
FDA flags heart pump linked to 49 deaths
The US Food and Drug Administration (FDA) has issued its highest-level alert about a heart pump that has been linked to 49 deaths and...
Another delay for Alzheimer’s drug as FDA sets up review panel
The FDA has delayed its decision on Eli Lilly’s highly anticipated Alzheimer’s drug donanemab and plans to convene an advisory committee to review it...
UK review calls for action on ‘biased’ medical devices
British experts have joined what’s growing into a global call for action on medical devices that are prone to unfair biases, including blood oxygen...
Asthma drug sanctioned for serious food allergies
Food allergies for products like milk, eggs, walnuts and peanuts could be more easily tolerated with a drug newly approved by the US Food...
FDA approves first cell therapy for metastatic melanoma
The US Food and Drug Administration (FDA) has approved lifileucel (Amtagvi, Iovance Biotherapeutics) for the treatment of certain adults with unresectable or metastatic melanoma, marking the first approval...
Label updates for anti-nausea jab products – FDA
The US Food & Drug Administration (FDA) has issued an alert regarding labelling updates intended to further reduce the risk of severe chemical irritation...
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...
New rights for UK donor babies as they turn 18
Around 30 young British adults – conceived via sperm or egg donation in the UK in 2005 – will soon be able to discover the...
NHLS refuses to share science data over Popia concerns
Researchers are at loggerheads with the National Health Laboratory Services for the latter’s interpretation of the Protection of Personal Information Act (Popia) and refusal...
FDA approves first natalizumab biosimilar for MS
There’s new hope for some people who suffer relapsing forms of multiple sclerosis (MS) — the chronic, inflammatory disease of the nervous system thought to...
FDA approves RSV jab for use in pregnant women
The US Food and Drug Administration has approved Pfizer’s respiratory syncytial virus (RSV) vaccine for use in women during the middle of the third...
FDA panel green-lights RSV pregnancy jab, but concerns persist
Despite some concerns, a US Food and Drug Administration (FDA) advisory panel has approved a Pfizer vaccine to be given to pregnant women that...
FDA preliminary nod for muscular dystrophy gene therapy
Despite some reservations, US Food and Drug Administration advisers have recommended the agency approve the first gene therapy for Duchenne muscular dystrophy, the most...
Health warnings on alcohol bottles for Ireland
In line with requirements for food packaging, Ireland plans to introduce health warning labels on alcohol products, listing risks as well as a product’s...
Muscle bulking supplement warning from FDA
The US Food and Drug Administration (FDA) says it continues to receive adverse event reports linked to selective androgen receptor modulators – or supplements...
Australia lifts Ivermectin restrictions
Prescribing oral Ivermectin for “off-label use” will no longer be limited to specialists like dermatologist, gastroenterologists and infections disease experts, says Australia’s Therapeutic Goods...
Nasal decongestant safety review due to rare brain risk
Experts are assessing a rare but potentially serious brain side effect of nasal decongestants containing pseudoephedrine, saying they might cause vessels supplying the brain...
New rules published for pharmacy fees
The South African Pharmacy Council has, in a Government Gazette notice, published rules relating to the services for which a pharmacist may levy a...
Pfizer booster stroke risk for seniors unlikely, says CDC
The risk of stroke for seniors from the Pfizer Omicron booster is “very unlikely”, the US Centres for Disease Control and Prevention (CDC) has...
Concern over FDA's fast-track approval of Alzheimer's drugs
The US Food and Drug Administration (FDA) has approved a highly anticipated new drug – Leqembi, also known as lecanemab – designed to slow cognitive...
UK approves one-shot RSV vaccine for babies
Britain’s regulator has given the go-ahead to a new single-shot vaccine that protects babies against the common and potentially dangerous winter virus known as...
SAHPRA authorises COVID home tests
South Africa’s medicines regulator has finally authorised COVID-19 home-test kits, after repeated calls for this for more than a year, now allowing people to...
Massive Philips recall highlights flaws in medical device surveillance
In the wake of several recalls of medical devices, including one of the largest in history in June last year by Philips Respironics (Philips),...
EU regulator blocks merger of US firms in cancer-screening sector
In a rare move by European regulators against two US companies, the European Union’s anti-trust watchdog has blocked the buyout of cancer-screening company GRAIL...
Australia put the brakes on cosmetic surgery ‘cowboys’
In the biggest crackdown on Australia’s $1.4bn cosmetic surgery industry, Health Minister Mark Butler and his state counterparts have agreed to sweeping changes focusing...
FDA approves over-the-counter hearing aids for Americans
The US Food and Drug Administration (FDA) has given the green light to over-the-counter (OTC) hearing aids, which will not only lower costs but...