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Comments Sought on CLIA Waivers

09/14/2012

Federal Register Notice: FDA is seeking public comment on collections of information associated with Clinical Laboratory Improveme...

Meeting on Study Data Exchange Standards

08/14/2012

Federal Register Announcement of meeting: “Regulatory New Drug Review: Solutions for Study Data Exchange Standards” to...

Animal Drug Sponsor Changed to Elanco

08/06/2012

Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for two NADAs, for Stresni...

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 ...