Guidance on Electrosurgical Device 510(k)s
03/24/2014
Federal Register Notice: FDA is making available a draft guidance entitled Premarket Notification (510(k)) Submissions for Electro...
Guidance on Vessel Sealer 510(k)s
03/24/2014
Federal Register Notice: FDA is making available a draft guidance entitled Premarket Notification (510(k)) Submissions for Bipolar...
Panel to Discuss 1st Immediate-Release Opiod Combo
03/24/2014
Selectors/Nominations Sought for Advisory Panel Consumer Reps
03/24/2014
Federal Register Notice: FDA is requesting that any consumer organizations interested in participating in the selection of voting ...
Comments Sought on Drug Approval Requirements
03/24/2014
OMB OKs Info on New Dietary Ingredient
03/18/2014
Federal Register Notice: FDA’s collection of information entitled “Premarket Notification for a New Dietary Ingredient...
Guidance on BA/BE Studies in NDAs/INDs
03/18/2014
Federal Register Notice: FDA is making available a draft guidance for industry entitled Bioavailability and Bioequivalence Studies...
Q&A Guidance on Humanitarian Device Exemption
03/18/2014
Info on Importer’s Entry Notice Sent to OMB
03/13/2014
Federal Register Notice: FDA’s proposed collection of information, “Importer’s Entry Notice,” has been sub...
Zefazone Not Withdrawn for S&E
03/10/2014
Federal Register Notice: FDA has determined that Zefazone (cefmetazole sodium) Injection, equivalent (EQ) to 1 g base/vial and EQ ...
