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Two state legislatures are considering biosimilar substitution bills, but are taking opposite approaches to the issues of prescriber notification and patient consent. Read More
Republican lawmakers warned the FDA on Wednesday to expect fiscal year 2016 funding levels to be in line with this year’s $4.4 billion, not the full $4.9 billion in funding that President Barack Obama asked for in his budget request. Read More
The SEC is urging drugmakers to include details of FDA correspondence about products in 8-K disclosure filings, or to post portions of them on their websites, to make sure shareholder communications are accurate. Read More
The FDA will hold a June 5 public hearing at its White Oak, Md., campus to discuss FY 2016 regulatory science research priorities for generic drugs. Read More
Sponsors of clinical trials that rely on data from x-ray and other images should send those images to a centralized reading facility to prevent accidental unblinding or bias that may occur at trial sites, the FDA says. Read More
Sponsors of clinical trials in India must begin reporting all deaths that occur “in clinical trials,” under final guidance issued Tuesday by the Central Drugs Standard Control Organization. Read More
Brand and generic drugmakers want the FDA to take responsibility for safety labeling changes to all drugs with at least one generic equivalent and scrap its proposed rule to give generics firms the ability to update label safety information independently. Read More
Chinese leaders want drugmakers to stop using third-party distributors and sell directly to hospitals in an effort to curb corruption in the supply chain. Read More