FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

Guidance on Evaluating Generic Opioid Abuse Deterrence

03/25/2016

Federal Register Notice: FDA is making available a draft guidance: General Principles for Evaluating the Abuse Deterrence of Gener...

CDRH Seeks Participants for Training Program

03/10/2016

Federal Register Notice: CDRH will sponsor the 2016 Experiential Learning Program (ELP). The training component is intended to pro...

Comments Sought on Info in ‘Dear Health Care Provider’ Guidance

03/10/2016

Federal Register Notice: FDA seeks public comments on the information collection associated with the guidance for industry and FDA...

FDA Sends Info on IDE Reports to OMB

03/10/2016

Federal Register Notice: FDA proposed collection of information “Investigational Device Exemptions Reports and Records,&rdqu...

FDA Sends Info on Emergency Use Authorizations to OMB

03/10/2016

Federal Register Notice: FDA’s proposed collection of information, “Emergency Use Authorization of Medical Products an...

Review Period Set for Opsumit

03/10/2016

Federal Register Notice: FDA has determined the regulatory review period for Actelion Pharmaceuticals’ Opsumit (macitentan) ...

FDA Proposes Cervical Screw Systems into Class 2

03/10/2016

Federal Register Proposed rule: FDA is proposing to classify posterior cervical screw systems into Class 2 (special controls) and ...

FDA Seeks Nominations, Selectors for Device Panels

02/18/2016

Federal Register Notice: FDA is requesting that any industry organizations interested in participating in the selecting nonvoting ...

FDA Submits Info on GRAS Notification to OMB

02/18/2016

Federal Register Notice: FDA’s proposed collection of information, “Substances Generally Recognized as Safe: Notificat...

FDA Requires PMA/PDP for Metal Hip Joint Prosthesis

02/18/2016

Federal Register Final order: FDA is issuing a final order to require the filing of a PMA or a notice of completion of a product d...