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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
The European Medicines Agency wants biosimilars makers to use pharmacodynamic markers alongside pharmacokinetic data to demonstrate biosimilarity. Read More
Drugs approved by regulators such as the FDA, European Medicines Agency, Heath Canada and the UK’s Medicines and Healthcare products Regulatory Agency would be deemed approved in Australia with only minimal in-country review under a proposal being pushed by the drug industry. Read More
The FDA plans to survey 1,500 adult patients to assess how people perceive prescription drug risks in direct-to-consumer television advertisements. Read More