FDA Webview
X
about-us-banner

Articles

Home /Articles / FDA Federal Register Notices

Info on PMA Approval Sent to OMB

09/17/2007

Federal Register Notice: FDA has submitted a proposed collection of information, “Premarket Approval of Medical Devices &mda...

Comments Reopened on IVD Assay Guidance

09/17/2007

Federal Register Notice: FDA is reopening until 10/17, the comment period for Draft Guidance for Industry, Clinical Laboratories, ...

Guidance on Commercial Analyte Specific Reagents

09/14/2007

Federal Register Notice: FDA is making available a guidance, Commercially Distributed Analyte Specific Reagents (ASRs): Frequently...

Mammography Advisory Committee to Meet

09/11/2007

Federal Register Notice: FDA’s National Mammography Quality Assurance Advisory Committee will meet 11/5, from 9 a.m. to 5 p....

Pharmacogenomic Data Submissions Guidance Out

08/29/2007

Federal Register Notice: FDA is making available a draft guidance, Pharmacogenomic Data Submissions — Companion Guidance. Th...

Orphan Drugs Info OK’d by OMB

08/29/2007

Federal Register Notice: FDA’s collection of information, “Orphan Drugs” has been approved by the Office of Mana...

FDA Proposes OTC Sunscreen Monograph Change

08/27/2007

Federal Register Proposed rule: FDA is proposing to amend the final monograph for OTC sunscreen drug products as part of the agenc...

FDA Corrects Info on ICH Prep Meeting

08/27/2007

Federal Register Notice: FDA is correcting an 8/13 Federal Register notice that announced a public meeting entitled “Prepara...

Comments Sought on Type A Medicated Articles Recordkeeping

08/16/2007

Federal Register Notice: FDA is seeking public comment on the recordkeeping requirements for current good manufacturing practice (...

FDA Proposes Blood Reg Updates

08/16/2007

Federal Register Proposed rule and direct final rule: FDA is proposing to amend the biologics regulations by removing, revising, o...