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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
The Brazilian government is providing more clarity around a voluntary program that encourages public-private partnerships to expand access to affordable drugs, but questions remain about the program’s transparency and how the market would be divided among competing partnerships. Read More
Sponsors submitting pediatric study plans should consider whether a product affects adults and children similarly when choosing an approach, the FDA says. Read More
Indian authorities issued a number of clinical trial regulations last month, covering compensation for trial injuries, exemptions for local Phase III trials and penalties for conducting trials without permission. Read More
An updated FDA guide on electronically submitting clinical study data, released last month, clarifies a number of requirements for preparing data sets and reviewers’ guides. Read More
Last year saw major strides in increasing transparency around clinical trial data in the EU and trial safety and compensation in India. An international group also set the gears in motion for a harmonized guideline on multiregional clinical studies.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 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