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With the launch of the FDA’s new Office of Pharmaceutical Quality, all ANDA filers are now eligible for the OPQ’s new real-time communications program – the quick-turnaround method the agency will use to resolve minor questions about chemistry, manufacturing and controls during ANDA reviews. Read More
The FDA plans to consolidate its 16 districts overseeing pharmaceutical imports into just four or five under a reorganization plan designed to make inspection policies and procedures more uniform across all ports of entry. Read More
The FDA has named Kathleen Uhl permanent director of the Office of Generic Drugs (OGD), where she has served as acting director since March 2013. Read More
The Institute of Medicine is calling on clinical trial sponsors and governments to develop plans for substantially greater sharing of clinical trial data. Read More
The UK’s health cost-benefit watchdog is recommending Gilead Sciences’ blockbuster hepatitis C cure, Sovaldi, be offered through the National Health Service to patients with three additional types of hepatitis C beginning in July. Read More
The FDA is asking drugmakers to evaluate all new psychoactive and other drugs for their potential to impair a patient’s driving ability and provide warning labelling if needed. Read More
India’s health ministry has given the go-ahead for 28 clinical trials, 14 of which are international studies, a continuation of the rebounding number of studies in the country. Read More
Global drug regulators have reduced drug approval times over the last 10 years, and while the FDA remains the fastest at approving new drugs, other regulators are closing the gap. Read More
Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More