USA – FDA issues 80 guidances for topical products
The FDA has issued eight new product-specific draft guidances and 72 revised draft guidances for sponsors of topical products applied to the skin or...
USA – FDA finalizes multiple endpoints guidance
The US Food and Drug Administration’s (FDA) on Thursday finalized guidance to sponsors on managing multiple endpoints in clinical trials to minimize the likelihood...
USA – Generic manufacturers call for changes to list of major deficiencies
Generic drug manufacturers are urging the US Food and Drug Administration (FDA) to revise its guidance on amendments to Abbreviated New Drug Applications (ANDA)...
USA – FDA starts PDUFA VII programs for real-world evidence, innovative trial designs
The US Food and Drug Administration (FDA) on Tuesday provided updates on two programs negotiated under the Prescription Drug User Fee Act (PDUFA VII)...
USA – Pharma industry making some headway in DSCSA implementation
The pharmaceutical industry and its trading partners are making “some progress” in implementing the necessary systems to comply with the Drug Supply Chain Security Act (DSCSA),...
USA – Comparability protocols: Final guidance incorporates ICH Q12, allows for API supplier changes
The US Food and Drug Administration’s (FDA) last week released a final guidance to assist the pharmaceutical industry in submitting comparability protocols for postapproval...
USA – FDA issues final guidance on AML drug development, two oncology draft guidances
The US Food and Drug Administration has published a final guidance and two draft guidances that detail its thinking on developing certain types of...
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 releases discussion paper on distributed and point-of-care manufacturing
The US Food and Drug Administration (FDA) has released a discussion paper on emerging and advanced manufacturing technologies concerning the distributed manufacturing (DM) and...
USA – FDA expands bivalent COVID boosters to kids as young as 5
The US Food and Drug Administration (FDA) has updated the emergency use authorizations (EUA) for the bivalent Pfizer-BioNTech and Moderna COVID-19 boosters to expand...
