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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
Several EU member states suspended marketing authorization for therapies that underwent bioequivalence testing at contract research organization GVK Biosciences’ facility in Hyderabad, India, citing serious concerns about deviations from good clinical practice. Read More
Companies developing biosimilars for the European market want regulators to revert to comparing therapies with the reference product based on the amount of active ingredient in a dose, rather than a proposed standard that compares dose with route of administration. Read More
In a preview of how the U.S. Food and Drug Administration’s new Office of Pharmaceutical Quality will speed generic drug approvals, the office is rolling out a framework for filers of abbreviated new drug applications to respond to minor queries regarding chemistry, manufacturing and control early in the review cycle. Read More