Comments Sought on Tobacco Substantial Equivalence Requirements
12/19/2013
OMB OKs Info on Device ID
12/19/2013
Federal Register Notice: FDA’s collection of information entitled “Unique Device Identification System,” has bee...
OMB OKs Info on Cardiovascular Labeling
12/19/2013
Federal Register Notice: FDA’s collection of information entitled “Guidance for Industry on Hypertension Indication: D...
Info on Device Communications Sent to OMB
12/19/2013
Workshop on Endpoints on Intraocular Lenses
12/19/2013
Federal Register Notice: FDA will hold a public workshop 3/28/14 entitled “FDA/American Academy of Ophthalmology (AAO) Works...
FDA Modernizes Citizen Petition Regs to Include E-Submissions
12/19/2013
Federal Register Final rule: FDA is modernizing its administrative regulations on submitting citizen petitions to explicitly provi...
FDA, CMS Extend Parallel Review Pilot
12/18/2013
Federal Register Notice: FDA and the Centers for Medicare and Medicaid Services have decided to extend the “Pilot Program fo...
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Federal Register Notice: FDA is making available a draft guidance for industry, Certification Process for Designated Medical Gases...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 ...
