Topic:

Regulatory

Latest Headlines

Latest Headlines

Medtronic joins St. Jude in leadless pacemaker market thanks to CE mark

Medtronic has officially joined the European leadless pacemaker market thanks to the CE-mark approval of its Micra Transcatheter Pacing System. It is one-tenth the size of conventional pacemakers, making it the world's smallest device in the overall category.

California health insurance exchange calls for copay caps on pricey meds

California's health insurance exchange staff is laying out a proposal that would cap copays for specialty drugs at a maximum of $500 per prescription, Capital Public Radio reports. And the caps would be even lower for some patients depending on their plan.

Australia's George Clinical eyes China drug discovery going global

Australia's George Clinical closely tracks China's growing number of domestic Contract Research Organizations and notes that of the estimated 250-odd companies, 90% are focused on domestic work. But George Clinical, based in Sydney, also looks ahead to the day the Chinese CROs and drug companies take bigger leaps into the global business.

IDT Australia release on FDA nod for 23 generics begs the question: Where's the beef?

Australia Stock Exchange-listed IDT Australia has issued another in a series of announcements about acquiring 23 generic drugs marketed in the United States, the latest release stating the U.S. FDA has noted the transfer of ownership to IDT.

India moves partially on bar codes for exported drugs by July

India drug authorities plan to impose bar-code rules on single cartons of exported drugs beginning July 1, but have deferred requiring the tags on individual bottles or vials of the products.

FDA clears patient monitoring device focused on IVs

ivWatch announced the FDA's clearance of its namesake product to continuously monitor peripheral IVs for adverse events like infiltration of IV fluids into the surrounding skin and the leakage of medications from the tubes.

FDA clears the way for Arrowhead's hep B treatment, with a caveat

Arrowhead is finally moving forward with a Phase IIb study on its hepatitis B treatment thanks to the FDA, but the company will need to further convince regulators before it can mount a larger effort.

Taiwan FDA recalls gastrointestinal drugs by 13 firms on ingredient quality issue

The Taiwan FDA ordered a recall of gastrointestinal drugs from 13 companies in case they used food-grade rather than pharmaceutical-grade ingredients in the products.

Counterfeit drugs ex-U.S. see four Asian nations atop the list

Take the United States out of the mix and the Asia nations of China, India, Pakistan and Japan were the four nations in the world with the most counterfeit drugs in 2013. That means, according to an expert, that the continent's residents are at a greater risk.

North Carolina shuts down animal drug compounder

North Carolina has shut down Fayetteville-based Prescription Center Pharmacy and ordered a U.S. and Canadian recall of veterinary products manufactured and distributed by the compounder.