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In two years’ time, manufacturers must submit applications for NDAs, ANDAs, INDs and BLAs using a set of approved electronic formatting standards, which the FDA finalized last month. Read More
Regulators, sponsors and clinical investigators wrestled with trial data transparency and reporting requirements for the second year in a row, with the European Medicines Agency trying to pin down the most effective ways to require sponsors to share the results of their studies. U.S. officials were primarily concerned with stimulating development of new antibiotics, encouraging sponsors and investigators to more deeply analyze subgroup outcomes and promoting the use of biomarkers in drug trials. 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
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
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More
Investigators conducting clinical trials in India could for the first time face up to five years in jail for trial violations if lawmakers approve a proposed bill, a possibility that could further hinder the country’s clinical trials industry, one expert says. Read More
China has agreed to streamline its regulatory processes and cut red tape for imports of new drugs, a move that should benefit the U.S. pharmaceutical industry, the U.S. Commerce Department says. Read More
Drug industry groups are urging the European Commission to invest more in research and development, streamline regulatory systems and accelerate recently approved clinical trial reforms as ways to bolster the EU’s pharmaceutical industry. Read More
Novartis’ cancer drug Afinitor failed to significantly increase survival rates for patients with a rare type of advanced breast cancer, casting further doubt on the drugmaker’s efforts to expand uses of the blockbuster therapy. Read More
Investigators have temporarily halted a trial of NewLink Genetics’ experimental Ebola vaccine after several patients reported unexpected side effects. Read More
The FDA is requesting industry feedback on the burdens related to its regulation of clinical safety and efficacy trials of unapproved new drugs and biologics. Read More
India’s Central Drugs Standard Control Organization has a released a draft document outlining accreditation and ethics standards for clinical trial sites, investigators and ethics committees. Read More