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Panel to Discuss Contact Lens Postmarket Use

05/22/2008

Federal Register Notice: FDA’s Ophthalmic Devices Panel of the Medical Devices Advisory Committee will meet 6/10, from 8 a.m...

Panel to Discuss Bladder Cancer Combo Product

05/22/2008

Federal Register Notice: FDA’s Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee will mee...

Guidance on Requalifying Blood Donors

05/21/2008

Federal Register Notice: FDA is making available a draft document, Guidance for Industry: Requalification Method for Reentry of Bl...

FDA OKs Minrad Canine Anesthetic

05/07/2008

Federal Register Final rule: FDA is amending the animal drug regulations to reflect approval of a Minrad Inc. ANADA that provides ...

CLIA Categorization Guidance

05/07/2008

Federal Register Notice: FDA is making available a guidance, Administrative Procedures for CLIA Categorization. It describes the a...

Comments Sought on Health/Nutrient Content Claims

05/07/2008

Federal Register Notice: FDA solicits comments on the collection of information associated with submitting notifications of health...

Info on Device Electronic Registration Sent to OMB

05/07/2008

Federal Register Notice: FDA’s proposed collection of information on the requirements that device establishments must submit...

Review Period Set for Tekturna

05/02/2008

Federal Register Notice: FDA has determined the regulatory review period for Novartis Corp.’s Tekturna (aliskiren hemifumara...

Comments Sought on Pet Food Labeling Survey

04/30/2008

Federal Register Notice: FDA is seeking public comment on its “Health and Diet Survey; Pet Food Labeling Survey.” The ...

Info on Device Registration and Listing Sent to OMB

04/30/2008

Federal Register Notice: FDA’s proposed collection of information, “Additional Listing Information for Medical Device ...