Topic:

Regulatory

Latest Headlines

Latest Headlines

FDA approves Purdue's OxyContin for use in youth aged 11 to 16

The addictive qualities of the powerful pain drug OxyContin have made it controversial, but the FDA has now approved it for youth 11 to 16 after asking maker Purdue Pharma to study its use in that age group.

NICE plots takeover of England's Cancer Drugs Fund

England's Cancer Drugs Fund has been dealing with budget overruns and backlash from drugmakers and patients unhappy with the fund's decision to ax certain meds from its list. Now, the country's cost watchdogs are planning to take the reins and give the fund a much-needed makeover.

India cardiac stent price caps closer after advisory review

An advisory body to India's health ministry has made a recommendation that favors price caps on cardiac stents based on price lists sent by manufacturers, the Economic Times reports.

ASLAN gets U.S. FDA orphan designation on ASLAN001

Singapore-based ASLAN Pharmaceuticals has received a U.S. FDA orphan designation for candidate ASLAN001 (varlitinib), a pan-HER inhibitor, as a treatment for cholangiocarcinoma,  a rare and very aggressive form of bile duct cancer which has no cure, the company said in a press release.

India's cabinet approves $270M to upgrade drug regulation

India approved spending of INR17.5 billion ($270 million) to upgrade its federal and state drug regulation system with the Cabinet Committee on Economic Affairs approval this week, the Economic Times reported.

JAMA: High-risk devices come with minimal safety studies

Amid growing pushback over the FDA's regulation of medical devices, a new study shows that many high-risk therapeutic devices that get the agency's approval have limited studies proving their safety and efficacy.

Australian pharma group says high manufacturing costs killing drug exports

A pharma industry group in Australia has warned the government that it needs to do something to relieve the high costs of drug manufacturing in the country or continue to lose exports. 

Another Indian CRO draws the ire of Western regulators

An Indian CRO that counts Johnson & Johnson, Novartis and Sanofi among its clients is under fire from the FDA for repeated quality control issues, the latest ding to the country's reputation as a go-to destination for outsourced drug development.

In a first, FDA clears a material enabling 3-D printing of dentures

Dentca announced that it received the first FDA clearance for a 3-D printed resin that's used as the base material during the denture repair and fabrication process.

UPDATED: Chinese plant banned by EU, getting compliance help from US company

Chinese drugmaker Jinan Jida has turned to a U.S. company to help it resolve plant issues that led the EU to suspend its certificate of suitability for the antibiotic nitrofurantoin last month.