Federal Register notice: FDA makes available a draft guidance entitled Definitions of Suspect Product and Illegitimate Product for Verification Obliga...
Federal Register notice: FDA seeks comments on post-marketing pediatric-focused safety reviews of products posted between 10/23/2017 and 3/16 on its W...
An FDA review of cancer drugs that used the accelerated approval program finds that very few of the resulting indications failed to verify clinical be...
CDER promotes Office of Strategic Programs director Theresa Mullin to a new position in Center director Janet Woodcocks immediate office associate di...
FDA approves an Otonomy NDA for Otiprio (ciprofloxacin otic suspension) 6% for treating acute otitis externa (swimmers ear) caused by Pseudomonas aeru...
FDA Review posts the latest Federal Register notices for the week ending 3/2/2018.
Federal Register notice: FDA makes available a draft guidance on Standardization of Data and Documentation Practices for Product Tracing.
Federal Register notice: FDA makes available a guidance entitled E18 Genomic Sampling and Management of Genomic Data.