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Republican lawmakers warned the FDA March 4 to expect fiscal year 2016 funding levels to be in line with this year’s $4.4 billion, not the full $4.9 billion requested. Read More
The FDA March 6 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
The House yesterday passed a bill that would allow drugs to be sold before the Drug Enforcement Agency permanently assigns them to a controlled substance schedule. Read More
Details are starting to emerge on how the FDA’s quality metric collection program will be structured, with drugmakers likely being able to submit metrics data electronically to the agency using a downloadable form. Read More