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    FDA issues final guidance on pediatric anti-infective development

    The US Food and Drug Administration (FDA) on Thursday issued a final guidance to assist sponsors in developing anti-infective drugs for the pediatric population. The guidance revises the draft version by providing more information on safety data collection and juvenile toxicity studies.   The guidance provides recommendations for developing anti-infective drugs, including antibacterials, antifungals, and antiparasitic products, for pediatric populations. A dra...
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    FDA shares research to improve dose selection in pediatric drug development

    Dose selection is a significant challenge in pediatric drug development; commonly used renal function equations can overestimate glomerular filtration rates and result in inaccurate predictions of drug elimination.   In a Regulatory Science in Action article , scientists from the US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) shared findings about how adjustments to the estimated glomerular filtration rate (eGFR) equations could help ...
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    FDA authorizes Pfizer COVID vaccine for younger kids

    The first US emergency use authorization (EUA) for younger children to receive a COVID-19 vaccine has been issued, the US Food and Drug Administration (FDA) announced Friday afternoon.   The mRNA vaccine developed by Pfizer in conjunction with the German firm BioNTech is now authorized for use in children aged 5-11 years. The Centers for Disease Control and Prevention (CDC) will convene a meeting of its immunization advisory committee next week to review clinical param...
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    Near-unanimous adcomm nod on Pfizer COVID vaccine for younger kids

    Younger school-aged children in the US came a step closer on Tuesday to having a COVID-19 vaccine available, with a positive vote from the US Food and Drug Administration's (FDA's) vaccines advisory committee for a reduced dose of Pfizer’s mRNA vaccine.   The vote was near-unanimous, with just one abstention and no “nays” among the 18 voting members of FDA’s Vaccines and Related Biological Products advisory committee (VRBPAC). Overall, the committee judged that the ben...
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    Tips for avoiding regulatory pitfalls in pediatric drug development

    Developers can improve their chances of success in getting pediatric drugs to market by consulting early with regulators in the US and the EU, understanding regulatory precedence and current context, and having a clearly defined clinical study design, experts advised at RAPS Convergence 2021.   One of the common hurdles in developing a pediatric drug product is navigating the different regulatory requirements in the US and Europe, said Linda McBride, a regulatory consu...
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    FDA, with academic and community partners, launches first pediatric ECG warehouse

    Pediatric electrocardiogram (ECG) data being collected by the US Food and Drug Administration are now available in a first-of-kind data warehouse.   The warehouse, a mirror of a similar data warehouse for adult ECG data, collects and makes available a rich store of information “to enhance cardiac safety review for therapeutic product development for children,” according to a new FDA Spotlight article announcing the launch of the warehouse.   One prong of the wo...