USA – Study: One-fifth of recent FDA approved drugs not authorized, reimbursed in other...
More than one-fifth of drugs recently approved by the US Food and Drug Administration (FDA) were not approved or recommended for public reimbursement in...
USA – Study: Extrapolation used in more than half of pediatric drug labeling changes
Some form of data extrapolation – either full or partial – was used in making more than 63% of pediatric labeling changes in the...
USA – Top FDA official interested in ‘Project Orbis’ for cell and gene therapies
A top official from the US Food and Drug Administration (FDA) said he wants to see something similar to the agency’s Project Orbis program...
Europe – Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 6 – 9...
EMA’s safety committee (PRAC) has started a review of medicines containing pseudoephedrine following concerns about the risk of posterior reversible encephalopathy syndrome (PRES) and...
USA – HHS prioritizing FDA labeling, DTC advertising, and compounded drug rules
The US Department of Health and Human Services (HHS) on Tuesday published a list of regulations its agencies will prioritize over the coming year....
UK – NICE publishes final draft guidance recommending three COVID-19 treatments
This includes those who are immunosuppressed, or who have other conditions such as heart disease, respiratory disease, diabetes or neurological disorders.
The agency’s latest guidance...
USA – FDA outlines criteria for conducting long-term neurodevelopmental safety studies in neonates
The US Food and Drug Administration (FDA) on Friday issued a draft guidance to assist sponsors in determining the need to conduct long-term neurodevelopmental...
UK – NICE fails to recommend Boehringer Ingelheim and Lilly Alliance’s empagliflozin
In a blow to patients who currently lack recommended treatment options for chronic heart failure with preserved or mildly reduced ejection fraction, Boehringer Ingelheim...
USA – FDA officials offer advice on gene therapy trials
Officials from the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) Office of Tissues and Advanced Therapies (OTAT) asserted...
International – ICH guideline M13A on bioequivalence for immediate-release solid oral dosage forms ICH...
ICH M13A Guideline is intended to provide recommendations on conducting bioequivalence (BE) studies during both development and post approval phases for orally administered immediate-release (IR) solid oral...
