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Guidance on Enrichment Strategies in Trials for NDAs, BLAs

12/17/2012

Comments Sought on HDE Applications

12/17/2012

Federal Register Notice: FDA is seeking public comment on information to accompany humanitarian device exemption applications and ...

Guide on RFID Studies is Extended

12/17/2012

Info on Tobacco Industry Meeting Guidance Sent to OMB

12/13/2012

Guidance Out on Design Considerations for Home Use Devices

12/13/2012

Guidance on Product Design Safety Considerations

12/13/2012

Device Product Name Corrected

12/13/2012

OMB OKs Info on Disease Info in Branded Promos

12/12/2012

Federal Register Notice: FDA’s collection of information entitled “Experimental Study: Disease Information in Branded ...

Small Business Guidance on OTC Sunscreen Product

12/06/2012

Guidance on Limiting Phthalates as Excipients in Drugs/Biologics

12/06/2012