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Comments Sought on CVM Electronic Submissions

05/16/2013

Federal Register Notice: FDA is seeking public comment on the existing reporting requests in CVM Guidance 108, How to Register wit...

FDA Classifies Ingestible Event Marker into Class 2

05/16/2013

Federal Register Final order: FDA is classifying the ingestible event marker into Class 2 (special controls) in order to provide a...

Comments Sought on Ruminant Feed Recordkeeping

05/16/2013

Federal Register Notice: FDA is seeking public comment on a proposed collection of information on extending OMB approval on the ex...

OMB OKs Info on Informed Consent for IVD Device Studies

05/10/2013

Comments Sought on Authorized Generic Drugs Reporting

05/10/2013

Federal Register Notice: FDA is seeking comments on the information collection contained in the requirements for reporting informa...

Panel to Discuss Organon NDA for Neuromuscular Blockade

05/10/2013

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Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...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