FDA issues a guidance on review times for certain complete response letters during the pandemic.
FDA publishes a question-and-answer guidance on the consumer antiseptic rub final rule.
Washington Legal Foundation asks an appeals court to uphold a lower court decision that a Humira patent settlement between AbbVie and several biosimil...
PhRMA asks FDA to withdraw its request for proposals for reimportation of insulin.
FDA issues a draft guidance to help sponsors develop individualized antisense oligonucleotide drug products.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...