Topic:

Regulatory

Latest Headlines

Latest Headlines

India plans pharma manufacturing clusters to ease costs

India's health ministry said the government plans to spend $27.3 million to establish ten clusters around the country for drug makers to share common production facilities and reduce their costs by 25%.

TB cases outside of lungs rise in India

India physicians report an uptick in the number of tuberculosis cases occurring not in the lungs, but elsewhere in the body even as they criticize the government for failing to see that patients have access to the drugs they need to treat the disease.

FDA under pressure to establish staff social media policy

Having faced years of criticism for its failure to publish guidelines on how the industry can use social media, the FDA is now being chastised by the advocacy group Union of Concerned Scientists over its lack of a policy for its staff.

FDA hustles on opioid guidance to avoid budget meddling

The FDA is rushing to complete guidance on abuse-deterrent opioids before the end of June because if it doesn't, Congress has promised to take away $20 million in money for salaries and expenses in the FDA Commissioner's Office and give it instead to its criminal investigations unit to fight drug diversion.

India tells drugmakers to pass along excise tax cut

India's National Pharmaceutical Pricing Authority has ordered all drugmakers to pass along to the consumer the recent reduction in the excise duty on imported medicines.

India agrochemical patent protection offers hope for multinational pharma

Foreign drugmakers could be about to get at least some of the increased patent protection they have been pressing for in India, if a government proposal in a related industry is any indication.

GSK's Breo for asthma? FDA panel says yes--but only in adults

Good news for GlaxoSmithKline: An FDA panel of experts says the efficacy and safety data for blockbuster wannabe Breo support the asthma indication it's gunning for in adults 18 and older. When it comes to children aged 12 to 17, though? The panelists aren't having it.

U.S. FDA softens approach in meetings with Indian regulators

The U.S. FDA is adopting a "carrot and stick" approach to the problems with India's pharmaceutical production. The new plan calls for rating India drugmakers and providing incentives for meeting good manufacturing practices along with use of its usual enforcement tools.

Medtronic's stent for peripheral artery disease wins expanded indication from FDA

After staving off Treasury Department rules, angry politicians and antitrust regulators, Medtronic is earning early victories from its $50 billion mega-acquisition of Covidien. The company announced that the former rival's Protégé GPS peripheral stent for treating peripheral artery disease now has the FDA's blessing to be used against lesions in the common and external iliac arteries, located in the pelvis.

FDA will discuss challenges and opportunities of robotic surgery at public meeting this summer

The FDA is putting robot assisted surgery in the spotlight this summer.