We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
Unauthorized knock-offs of Gilead’s pricey blockbuster hepatitis C therapy, Sovaldi, may soon hit the market in India after the government refused to grant it patent protection. Read More
Hikma Pharmaceuticals will launch its gout treatment, Mitigare, after a federal court rejected Takeda’s arguments to block the product, which would compete with Takeda’s drug Colcrys. Read More
Beginning yesterday, 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