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In a preview of how the FDA’s Office of Pharmaceutical Quality will speed approval of generic drugs, the office is rolling out a framework for ANDA filers to respond to minor agency queries involving chemistry, manufacturing and control issues early in the review cycle. Read More
The UK’s health cost-benefit watchdog is recommending coverage of Janssen’s drug Olysio as a treatment option for people with both genotype 1 and genotype 4 hepatitis C. Read More
Manufacturers that combine drugs with either medical devices or cellular or tissue-based products must determine which category the product falls under before filing a marketing application in Japan, the Pharmaceutical and Medical Devices Agency says. Read More
Ebola vaccine manufacturers Janssen, GlaxoSmithKline and NewLink Genetics will be sheltered from legal liability under a law that protects companies that produce treatments to combat public health emergencies, the U.S. government says. Read More
New Zealand’s regulatory authority is updating its uniform recall procedure for drugs, following a recent decision not to pursue a joint authority with Australia. Read More
Brand drugmakers in Europe are calling on the European Commission to implement a system to facilitate the resolution of patent disputes before a generic version is launched, a move they say would curb inefficiencies in the current patent litigation system. Read More
The FDA is considering a new inspections scoring system that would, for the first time, recognize drugmakers that go beyond normal compliance with good manufacturing practices. Read More
India’s drug pricing authority has placed 52 additional drugs under price control, including treatments for cancer, skin disorders and infection, as part of a program to provide life-saving and essential medicines to the public. Read More
India’s Central Drugs Standard Control Organization has proposed accreditation and ethics standards for clinical trial sites, investigators and ethics committees. Read More