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Guidance for Antibacterial Therapies

07/08/2013

Comments Sought on Lung Cancer Drug Info

07/08/2013

Guidance on Certification for Medical Gases

12/18/2012

Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...

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