USA – New FDA guidance offers ethical roadmap for including children in clinical trials
The US Food and Drug Administration (FDA) has issued draft guidance outlining a series of ethical considerations for conducting clinical trials that involve children.
The guidance,...
USA – FDA issues guidance documents on labeling drug identity, constituents
The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC)...
USA – FDA finalizes guidance on charging for investigational drugs
The US Food and Drug Administration (FDA) on 14 February finalized guidance specifying the circumstances when sponsors can charge for an investigational drug in...
USA – FDA issues guidances on facility readiness and early DMF assessments under GDUFA...
The US Food and Drug Administration’s (FDA) on 3 October released two draft guidances that implement new enhancements under the new Generic Drug User...
USA – FDA releases guidance on labeling of drug use-related software outputs
The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in...
USA – FDA issues last guidance in patient-focused drug development series
The US Food and Drug Administration (FDA) has published its fourth and final guidance in a series of patient-focused drug development (PFDD) guidances meant...
USA – FDA finalizes guidance on electronic submission of BA/BE adverse event reports to...
The US Food and Drug Administration (FDA) has finalized guidance that spells out how generic drug manufacturers can electronically submit expedited individual case safety...
USA – FDA Approves Prescription Nasal Spray to Reverse Opioid Overdose
Today, the U.S. Food and Drug Administration approved Opvee, the first nalmefene hydrochloride nasal spray for the emergency treatment of known or suspected opioid...
USA – FDA unveils draft guidance on REMS logic models
The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s risk evaluation and mitigation strategy (REMS) logic model.
FDA described...
USA – FDA issues guidance on submission of pharmacogenomic data
The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory...
