A five-month legal battle over the duties of trial sponsors to publish results has ended with a judge ruling the UK regulator acted unlawfully and sponsors will not be required to publicly register UK Phase I adult trials which began before September...
What may seem to be relatively minor changes between the FDA’s draft and final guidance on delaying, denying, limiting or refusing a facility inspection could actually be more major as two lawyers called the final guidance, “critically vague and legally...
Evotec has taken legal action to recover €3.4m ($4.4m) in milestone payments from Andromeda Biotech which was found to have faked data in a Phase III trial.
New Human Medicines Regulations came into effect this morning, overhauling the UK's regulations on drug manufacturing, importation, distribution, packaging and pharmacovigilance.
The shipping requirements of drugs means the TSA’s new law poses unique problems to the pharma industry, according to DHL, but experience of tight regulations should help companies achieve compliance.
US eClinical firm Phase Forward has created the new executive role, “chief privacy officer,” to ensure it complies with the latest data protection and privacy regulations governing the trial sector.
Contracting giant Patheon has started legal action to restrict the voting rights of private equity group JLL Holdings, in the latest move of an increasingly acrimonious takeover battle.
China is a big market with a lot of potential but many pharma
industry firms still avoid doing business in the country because of
fears that their intellectual property (IP) cannot be protected.
