Research and Development

FDA and NIIMBL Team Up on Advanced Biopharma Manufacturing

Following an agency-wide e-mail from the Acting FDA Commissioner marking an increased focus on emerging technologies, the agency has forged a research partnership with the National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) to spur innovation in advanced manufacturing. Read More

FDA Offers Advice to Sponsors of ADHD Drugs

The FDA released a draft guidance for sponsors of stimulant drugs for treating attention deficit hyperactivity disorder (ADHD) with recommendations for clinical trials and new drug applications. Read More

FDA Asked How to Unblind Blood Cancer Trials

Drug companies and a contract research organization are urging the FDA to sharpen its recommendations on how to reveal to blood cancer patients whether they’re taking placebos or the real thing in clinical trials. Read More