USA – FDA encourages RCTs in accelerated approval guidance for oncology
The US Food and Drug Administration (FDA) issued draft guidance on the design of oncology trials for accelerated approval, calling randomized controlled trials (RCTs)...
USA – NCI official raises concerns about FDA’s cancer drug dose optimization guidance
The head of the National Cancer Institute’s (NCI) investigational drug research branch said that recent draft guidance from the US Food and Administration (FDA)...
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The US Food and Drug Administration (FDA) has issued draft guidance to clarify which pharmacogenomic study findings and data should be included in regulatory...
USA – Advanced manufacturing: GAO, USP reports say regulatory enhancements needed
The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of...
USA – Industry requests more information from FDA on dosage and administration labeling
While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of...
USA – FDA finalizes guidance on suspect products under DSCSA
The US Food and Administrations (FDA) on Thursday finalized guidance defining what constitutes suspect and illegitimate products, as well as what constitutes products that...
USA – FDA issues guidance on developing long-acting local anesthetics
The US Food and Drug Administration (FDA) has issued draft guidance on the development of local anesthetic products with a prolonged duration of effect...
USA – Pharma wants FDA’s IND reporting rule better aligned with ICH E2F
Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with...
USA – FDA revises guidance on electronic systems and signatures in clinical trials
The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance on electronic systems, records and signatures in clinical trials. While the...
USA – Advanced manufacturing: GAO, USP reports say regulatory enhancements needed
The Government Accountability Office (GAO) and the United States Pharmacopeia (USP) asserted in two recent reports that the regulators need to address some of...
