FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

2 Finalized eCTD Documents Available for E-Submissions

08/06/2012

Federal Register Notice: FDA is making available final versions of documents that support making regulatory submissions in electro...

Grant Funds Available for Orphan Products

08/06/2012

Federal Register Notice: FDA is announcing the availability of grant funds to support FDA’s Office of Orphan Products Develo...

Info on Labeling Non-Rx Drugs Sent to OMB

07/26/2012

Comments Sought on Generic Drug User Fee Collection of Info

07/26/2012

Pediatric Devices Workshop Slated

07/26/2012

Federal Register Notice: FDA’s Office of Orphan Products Development is will hold the FDA Pediatric Medical Devices Workshop...

Info on Investigator Financial Disclosure Sent to OMB

07/26/2012

Federal Register Notice: FDA’s proposed collection of information, “Financial Disclosure by Clinical Investigators,&rd...

OMB OKs Info on Animal Drug Bioequivalence

06/27/2012

Federal Register Notice: FDA’s collection of information entitled “Waivers of In Vivo Demonstration of Bioequivalence ...

OMB Approves State Enforcement Notifications Info

06/27/2012

Federal Register Notice: FDA’s collection of information entitled “State Enforcement Notifications” has been app...

Info on Postmarket ADERs Sent to OMB

06/27/2012

Federal Register Notice: FDA’s proposed collection of information, “Postmarketing Adverse Drug Experience Reporting &m...

Guidance on Lupus Nephritis Withdrawn

06/27/2012

Federal Register Notice: FDA is withdrawing a 6/22/10 guidance, Lupus Nephritis Caused By Systemic Lupus Erythematosus — Dev...