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...
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The US Food and Drug Administration (FDA) on Friday issued a draft guidance to assist sponsors in determining the need to conduct long-term neurodevelopmental...
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...
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...
USA – FDA releases FY 2022 generic drug research summary
The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) on Tuesday released a report summarizing its research activities in fiscal year...
USA – FDA draft guidance addresses clinical development of drugs to treat early Lyme...
The US Food and Drug Administration (FDA) Center for Drug Evaluation Research (CDER) has issued a draft guidance to help sponsors develop new drugs...
USA – FDA draft guidance addresses use of external controls to assess effectiveness of...
The FDA Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) have issued draft guidance describing sponsors...
USA – FDA issues draft guidance on developing drugs for acromegaly
The US Food and Drug Administration (FDA) has issued a draft guidance to assist sponsors develop acromegaly treatments for patients who have either not...
