Europe – Human medicines: highlights of 2022
In 2022, EMA recommended 89 medicines for marketing authorisation. Of these, 41 had a new active substance which had never been authorised in the European Union (EU)...
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 – 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The US Food and Drug Administration (FDA) on Friday issued a draft guidance to assist sponsors in determining the need to conduct long-term neurodevelopmental...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...
USA – DSCSA: New interoperability ‘blueprint’ released
With less than a year remaining before the Drug Supply Chain Security Act (DSCSA) takes full effect, an industry consortium has published new chapters of a...
