USA – FDA updates guidance on evaluating out-of-specification results for drugs
The US Food and Drug Administration (FDA) has revised its 16-year-old final guidance on procedures for reviewing out-of-specification (OOS) results in the laboratory, including...
USA – Experts discuss red flags that can trigger legal action against drug and...
Legal observers discussed some of the red flags that can trigger legal actions against healthcare product manufacturers, as well as some of the lessons...
USA – FDA to form task force, public-private partnership on rare neurodegenerative diseases
The US Food and Drug Administration (FDA) released a five-year action plan for accelerating drug development for rare neurodegenerative diseases, such as amyotrophic lateral...
USA – FDA issues draft guidance on pulmonary tuberculosis drugs
The US Food and Drug Administration (FDA) has released new draft guidance on developing drugs for pulmonary tuberculosis.
FDA’s latest draft guidance is intended to...
USA – FDA: Genome editing therapies may use accelerated approval pathway
The US Food and Drug Administration (FDA) has finalized guidance to assist sponsors developing gene therapy products that incorporate genome editing (GE) of human...
USA – Data Integrity for In Vivo Bioavailability and Bioequivalence Studies: Guidance for Industry
The purpose of this guidance is to provide recommendations to applicants and testing site
management on achieving and maintaining data integrity for the clinical and...
USA – FDA expands scope of off-label guidance to include presentations from reprints
The US Food and Drug Administration (FDA) has revised draft guidance on the dissemination of information to health care providers (HCPs) regarding off-label uses...
USA – Psychedelic drug trial guidance: Commenters see vital role for psychotherapy
Commenters on the US Food and Drug Administration’s (FDA) first guidance on clinical investigations and drug development programs for psychedelic drugs raised concerns about...
USA – FDA sets acceptable intake limits for nitrosamines in drugs
The US Food and Drug Administration (FDA) on Friday issued a final guidance that outlines a framework for predicting the mutagenic and carcinogenic risk...
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While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of...
