Topic:

Regulatory

Latest Headlines

Latest Headlines

Cochlear scores critical FDA approval for its innovative hearing aid system

In a major regulatory win, Cochlear--the world's largest maker of hearing aids--scored FDA approval for its next-generation hearing device to treat sensorineural hearing loss.

St. Jude Medical grabs a CE mark for 'burst' neurostim treatment of chronic pain

St. Jude Medical nailed a CE-mark approval for the company's next-generation neurostimulation device to treat chronic pain. The European regulatory win allows it to hit the market overseas with its Prodigy system even as it ramps up for U.S. clinical trials of the novel product.

Pfizer snags a 'breakthrough' tag for its meningitis vaccine in a race with Novartis

Pfizer picked up the FDA's breakthrough therapy designation for an in-development vaccine against meningococcal disease, a common cause of meningitis, lighting the path for an accelerated approval as the drugmaker looks to expand its vaccine portfolio beyond the blockbuster Prevnar 13.

New heart-disease guidelines could mean 12.8M new statin patients, NEJM study finds

New statin-use guidelines divided cardiologists when they were rolled out in November, because they would put millions more patients in line for the drugs. Now, new research estimating their impact puts the number of eligible statin patients even higher than some originally thought.

Pay-for-delay: Is cash the only antitrust test that matters in patent settlements?

Patent settlements between drugmakers and generic manufacturers have drawn even more scrutiny since the U.S. Supreme Court ruled last summer that the Federal Trade Commission has a right to challenge them. At issue are "pay-for-delay" deals, in which manufacturers of branded drugs pay generics challengers to refrain from launching copies until an agreed-upon date.

Indian regulator finds number of substandard drugs on the rise

With FDA bans of products from some of India's largest drugmakers has come growing debate about the quality of drugs shipped to the U.S. Now sampling by the Drug Controller General of India since December 2012 has found that about 2.3% of products tested failed to meet standards.

Geron sinks as liver risks plague another imetelstat trial

A week after the FDA put a halt to Geron's in-house studies of the cancer drug imetelstat over toxicity concerns, the agency stepped in on a Mayo Clinic-run trial of the same treatment, citing familiar dangers and imposing a partial clinical hold.

FDA cuts U.S. plant inspections while boosting them overseas

For years the FDA has been trying to level the playing field in terms of foreign versus domestic drug manufacturing plant inspections. It wasn't many years ago when U.S. facilities could expect a visit every 30 months while foreign plants would go 5 or more years between inspections. One way to achieve parity is to cut the number of U.S. inspections while doing more overseas, and that is what the FDA proposes to do.

Senators ask FDA for answers about its regulation of mobile medical apps

The mobile medical app regulation saga continues: Congress sent the FDA a letter this week to inquire about the agency's regulation of the technology and to clarify a few talking points, MobiHealthNews reported.

FDA jumps compounder for making unapproved domperidone

According to a warning letter sent Feb. 28 and posted this week on the FDA website, Total Pharmacy Services has been making domperidone, a drug some breastfeeding women take to boost lactation.