Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Section Content Menu Skip to Common Links
-

FDA Application

Federal Register
Friday October 9, 2009

Planning to Submit Comments?

Documents and comments received by the Division of Dockets Management may be posted on the Internet. Please do not include personal identifying information, i.e. date of birth, social security number, medical information, etc., in your correspondence.
Submit Electronic Comments

Documents are on display for public inspection at the Division of Dockets Management, 5630 Fishers Lane (Room 1061), HFA-305, Rockville, MD, 20852; 301-827-6860; TTY/TDD Users 1-800-735-2258.

FDA Federal Register Documents

NOTICES-FINAL GUIDANCES

Docket No. FDA-2009-D-0118, CDRH 200842.  Guidances for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Documents: Respiratory Viral Panel Multiplex Nucleic Acid Assay; and Testing for Human Metapneumovirus Using Nucleic Acid Assays; and Testing for Detection and Differentiation of Influenza A Virus Subtypes Using Multiplex Nucleic Acid Assays; Availability.  Pages  52244-52245 [FR Doc. E9-24431]  [OFR PUB]

NOTICES-DRAFT GUIDANCES

Docket No. FDA-2009-D-0448, CDRH 200863.  Draft Guidance for Industry and Food and Drug Administration Staff; the Mammography Quality Standards Act Final Regulations: Modifications and Additions to Policy Guidance Help System #13; Availability.  Pages  52242-52243 [FR Doc. E9-24435]  [OFR PUB] Comments due January 7, 2010

NOTICES

Docket No. FDA-2009-E-0073 and FDA-2009-E-0015, CDER 200950.  Determination of Regulatory Review Period for Purposes of Patent Extension; Entereg; U.S.Patent Nos. 5,250,542 and 5,434,171.  Pages  52241-52242 [FR Doc. E9-24457]  [OFR PUB] Comments due December 8, 2009 Due diligence petitions due April 7, 2010

FINAL RULES

Docket No. FDA-2009-N-0119, CDRH 200843.  Medical Devices; Immunology and Microbiology Devices; Classification of Respiratory Viral Panel Multiplex Nucleic Acid Assay.  Pages  52136-52138 [FR Doc. E9-24432]  [OFR PUB] Effective date November 9, 2009

Table of Contents for Entire Federal Register
Friday, October 9, 2009 [Not Available]

 
-
-
-
-
-