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The FDA Friday gave a green light to the first U.S. biosimilar, finding Sandoz’s Zarxio clinically comparable to Amgen’s blockbuster chemotherapy product Neupogen. Read More
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