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The European Medicines Agency appears to be backing off promises to protect industry trade secrets in its new clinical trials database, and is developing scenarios under which it would release commercially confidential information. Read More
The European Medicines Agency appears to be backing off promises to protect industry trade secrets in its new clinical trials database, and is developing scenarios under which it would release commercially confidential information. Read More
Sponsors of multisite clinical trials should take greater advantage of their ability to use a single institutional review board, according to a draft policy that requires the practice for all NIH-supported domestic trial sites. Read More
German regulators have published a list of 80 generic medicines whose approvals were yanked after EU authorities expressed concerns with contract research organization GVK Biosciences. Read More
Sponsors of multi-site clinical trials should take greater advantage of their ability to use a single institutional review board, says a draft policy that seeks to require the practice for all NIH-supported domestic trial sites. Read More
Sponsors of novel drug therapies can evaluate their candidates against competing products in the UK without the threat of litigation, thanks to amended patent law that took effect Oct. 2. Read More
New amendments to patent laws in the UK could create a more attractive place for innovator drug companies to conduct clinical trials for novel drugs, experts say. Read More
Indian regulators are reminding drug investigators seeking approval for clinical trials that they must submit information on the unmet medical need and risk-benefit assessments of the proposed drug, as well as comparisons of the innovator product to existing options. Read More
Clinical trial investigators in India must limit their work to no more than three trials at any given time, according to one of the mandates in 14 finalized regulations issued by the Central Drugs Standard Control Organization. Read More
Clinical trial investigators in India must limit their work to no more than three trials at any given time, according to one of the mandates in 14 finalized regulations issued by the Central Drugs Standard Control Organization.
Read More
Clinical trial investigators in India must limit their work to no more than three trials at any given time, according to one of the mandates in 14 finalized regulations issued by the Central Drugs Standard Control Organization. Read More