Research and Development

FDA Gets Ready for ‘Data-Rich’ Future

The FDA released a new plan on Wednesday for using data to help bridge the “persistent gap” between scientific innovations and the technology needed to develop them into therapies. Read More

FDA and NIIMBL Team Up on Advanced 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 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The FDA released a draft guidance for sponsors of stimulant drugs for treating attention deficit hyperactivity disorder (ADHD) with recommendations for clinical trials and new drug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