USA – Industry groups: Expand FDA’s RTOR guidance to cell and gene therapies
Stakeholders commenting on the US Food and Drug Administration (FDA) draft guidance with recommendations for applicants submitting New Drug Applications (NDA) and Biologic License...
USA – FDA relaxes EUA advertising limitation for some COVID drugs
The US Food and Drug Administration (FDA) has relaxed a limitation on advertising and promotion for certain COVID-19 drugs with emergency use authorizations (EUAs)....
USA – FDA details approach for finding optimal dosages for new cancer drugs
The US Food and Drug Administration (FDA) has issued a draft guidance to help sponsors identify the optimal dosage for cancer drugs in clinical...
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While the US Food and Drug Administration’s (FDA) latest draft guidance on improving the consistency of information in the dosage and administration section of...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 considers new efficacy endpoint for diabetes drugs
The US Food and Drug Administration (FDA) on Friday released an updated draft guidance to help sponsors demonstrate efficacy for new antidiabetic drugs and...
USA – FDA guidance focuses on Real-Time Oncology Review program
How does a cancer drug cross the FDA finish line 3-5 months before its PDUFA date? That’s where the Real-Time Oncology Review comes in.
For...
USA – FDA addresses alternative inspection tools, expectations for nitrosamine assessments in updated CPGs
The US Food and Drug Administration’s (FDA) has updated two compliance program guides (CPGs) covering pre-approval inspections (PAIs) and routine good manufacturing practice (GMP)...
USA – FDA updates statistical approaches for assessing bioequivalence
The US Food and Drug Administration (FDA) has published a draft guidance updating its principles for assessing in vivo or in vitro bioequivalence studies...
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 – FDA updates guidance on reporting manufacturing disruptions for finished products and APIs
The US Food and Drug Administration (FDA) on Wednesday issued draft guidance that outlines how drugmakers should notify the agency of a discontinuance or...
