FDA issues a draft guidance to help sponsors develop individualized antisense oligonucleotide drug products.
Federal Register notices published the week ending 1/01/2021 while we were on our annual holiday break.
Federal Register notices published the week ending 12/25/2020 while we were on our annual holiday break.
FDA Webview posts the latest Warning Letters that were released the weeks ending 12/25/2020 and 1/1/2021 while we were on our annual holiday break and...
FDA approves 53 new molecular entities in 2020, which is five (10%) more than it approved in 2019 despite challenges from balancing resources to navig...
FDA releases the FDA-483 with five observations from an inspection at Legacy Pharmaceutical Packaging, a medical device contract manufacturer.
FDA posts a draft guidance entitled Dry Eye: Developing Drugs for Treatment that is intended to provide recommendations to sponsors about eligibility ...