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Indian officials are accusing FDA investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for Indian regulators to tag along on FDA drug manufacturing inspections as observers. Read More
Indian companies that export active pharmaceutical ingredients to the EU can use six months of long-term stability data to show conformity with good manufacturing practices, rather than the previously required 12 months of data. Read More
From now on, all NDAs will undergo a risk assessment by a team of FDA reviewers that will follow the drug from preapproval through manufacturing and into any eventual generic forms in an effort to ensure quality throughout a product’s lifecycle. Read More
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
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
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
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