Topic:

Regulatory

Latest Headlines

Latest Headlines

India takes another step to meet looming EU API rules

With just weeks to go, one India government agency has just laid out the guidelines for API makers to follow in order to meet the new EU standards for certifying APIs that go into effect on July 2.

Indian regulators unsure how to react to USFDA actions

India is trying to figure out its response to the fact that two of its largest generic drugmakers, Ranbaxy Laboratories and Wockhardt, have been targeted by the FDA because of serious manufacturing lapses. 

India amps up clinical trial consent regulations

India is on its way to requiring clinical trial participants to state their consent to a video camera before undergoing treatment, a move aimed to reduce the number of patients deluded into studies with false information.

UPDATED: FDA tracking down new outbreak tied to compounded drug

Call it FDA déjà vu. While Congress continues to spar with the FDA over its oversight of compounding pharmacies, agency officials are running down yet another outbreak of possible infections tied to a potentially contaminated steroid manufactured by a compounding pharmacy.

Alexion snags latest 'breakthrough' coup with PhIII rare-disease drug

Already handed an orphan drug designation alongside fast-track status, the FDA has added the highly sought after "breakthrough drug" designation for the therapy, which could further shave some time off the development schedule.

Pharmaxis slashes staff after FDA red-flags cystic fibrosis treatment

The biotech says it will cut 48 jobs, or about a third of its workforce, as it gets ready to try to satisfy regulators with another study of the therapy, which is marketed in Europe.

FDA sticks 'deadly' tag on Cook's stent recall

The FDA has affixed its most serious warning to Cook Medical's recall of the Zilver PTX stent, warning that problems with the device's delivery catheter could lead to thrombosis, amputation or death.

FDA responds to one small piece of Avandia criticism

The FDA yesterday responded to a Forbes op-ed from Steven Nissen, Chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic, published earlier that day. In it, Nissen railed the...

Novartis apologizes over Diovan study as probe shows employee involvement in trials

Novartis' blood pressure Diovan is on the wane as its expects generics next quarter to begin eating at its blockbuster status. But even as it comes under attack by generics, so does its reputation, as a probe by Novartis reveals that not everything in its trials in Japan followed accepted protocol.

Roche wins FDA approval for novel diabetes Dx

Roche won the FDA's blessing to market a hemoglobin-based diabetes diagnostic, the latest advance in testing for the disease and the first assay of its kind approved in the U.S.