The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device 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
Researchers should use innovative approaches and all information available when designing a neonatal study, as neonates come with serious considerations, such as a limited amount of circulating blood and rapid and varying rates of maturation, the agency advises in draft guidance. Read More
The FDA released a draft guidance for sponsors of stimulant drugs for treating attention deficit hyperactivity disorder (ADHD) with recommendations for clinical trials and new drug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
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