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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
The guidance points out that conventional pharmacokinetic studies that use intensive blood sampling can rarely be used in neonate studies due to their limited circulating blood volume. 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such as a limited amount of circulating blood and rapid and varying rates of maturation, the agency advises in draft guidance.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The FDA released a draft guidance for sponsors of stimulant drugs for treating attention deficit hyperactivity disorder (ADHD) with recommendations for clinical trials and new drug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
The European Medicines Agency released revised guidelines on Monday for stakeholder comment on evaluating drugs for treating bacterial infections. 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
Drugs targeting the central nervous system take significantly longer to develop and get approved than other meds, according to a new analysis. Read More
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