Guidance Page
...Guidance Documents .. Your browser does not seem to support Frames. Either download a.....gov/cder/guidance.htm..
http://www.fda.gov/cder/guidance/ (score=100)

Untitled Document
...Online search of CDRH guidance documents.. Guidance documents from FDA.. CDRH Facts on.....Annual Guidance Document Agenda..   About Guidance.. What is guidance? Abbreviations of CDRH offices producing guidance.....Guidance Documents Home Page....FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index..
http://www.fda.gov/cdrh/guidance.html (score=94)

Guidance for Institutional Review Boards and Clinical Investigators
...This document represents the agency's current guidance on protection of human subjects of.....This guidance document represents an update of the October 1995 revision of the.....It is published as Level 2 guidance in accordance with the FDA "Good Guidance Practices." It does not create or confer any rights..
http://www.fda.gov/oc/ohrt/irbs/default.htm (score=94)

Guidance for Industry - Part 11, Electronic Records; Electronic Signatures...
...draft guidance when that draft guidance may no longer represent our approach under the.....For further guidance on validation of computerized systems, see FDA's guidance for.....This document provides guidance to persons who, in fulfillment of a requirement in a..
http://www.fda.gov/cber/gdlns/prt11elect.pdf (score=86)

General Principles of Software Validation; Final Guidance for Industry and...
...For questions regarding the use or interpretation of this guidance which involve the.....For questions regarding the use or interpretation of this guidance which involve the.....This guidance outlines general validation principles that the Food and Drug Administration..
http://www.fda.gov/cdrh/comp/guidance/938.html (score=81)

Guidance Documents for Drug Applications
...For information on a specific guidance document, please contact the originating office.....Guidance documents represent the Agency's current thinking on a particular subject. These.....Guidance Document for Emergency INDs.. The Guidance for Institutional Review Boards and Clinical Investigators contains information..
http://www.fda.gov/cder/regulatory/applications/guidance.htm (score=79)

http://www.fda.gov/cder/guidance/5900dft.pdf (score=77)

FDA PROPOSES NEW INDUSTRY DRAFT GUIDANCE FOR EVALUATING THE SAFETY OF...
...The Food and Drug Administration is announcing the availability of a draft guidance document entitled "Guidance for.....FDA PROPOSES NEW INDUSTRY DRAFT GUIDANCE FOR EVALUATING THE SAFETY OF ANTIMICROBIAL NEW.....This draft guidance discusses a recommended approach for assessing the safety of..
http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01162.html (score=75)

Guidance for Off-The-Shelf Software Use in Medical Devices
...This guidance document was developed to address the many questions asked by medical device.....documentation described in the Guidance for the Content of Premarket Submissions for.....The guidance provided in this document reflects a safety-based approach to risk management..
http://www.fda.gov/cdrh/ode/guidance/585.pdf (score=75)

Time Stamps Guidance
...1 This draft guidance was prepared under the aegis of the Office of Enforcement by the FDA.....manufacturing process, are beyond the scope of this draft guidance document, but you.....Additional copies of this draft guidance document are available from the Office of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1542_gdl0001.pdf (score=74)

Microsoft Word - 5666fnl.doc
...This document is intended to provide guidance to Federal agencies and to state and local.....2 For purposes of this guidance, end users are consumers who have purchased KI, or.....recommendations in that guidance addressed KI dosage and the projected radiation exposure..
http://www.fda.gov/cder/guidance/5666fnl.pdf (score=74)

Guidance Agenda
...See the Good Guidance Practices (GGPs) regulation on this Web page or 21 CFR 10.115 for.....Regulatory Guidance.. Date created: January 30, 2004.. CDER Home Page | CDER Site Info.....Guidance Agenda: Guidances CDER is Planning to Develop During Fiscal Year 2004..
http://www.fda.gov/cder/guidance/guidance-agenda.htm (score=73)

FDA, Financial Disclosure by Clinical Investigators
...This guidance represents the Food and Drug Administration's current thinking on this topic.....On October 26, 1999, FDA published a draft guidance to provide clarification in.....1 This guidance has been prepared by the Implementation Team for Financial Disclosure..
http://www.fda.gov/oc/guidance/financialdis.html (score=73)

Draft Guidance for Industry
...1 This draft guidance was prepared under the aegis of the Office of Enforcement by the FDA.....guidance also addresses attributes of such electronic copies that make them accurate.....Additional copies of this draft guidance document are available from the Office of..
http://www.fda.gov/OHRMS/DOCKETS/98fr/00d-1540-gdl0001.pdf (score=73)

FDA Issues Final Guidance on Reuse of Single-Use Medical Devices
...FDA today issued final guidance on the practice of reusing medical devices intended to be.....The guidance is designed to protect the public health by assuring that the practice of.....Under the final guidance, FDA will regulate third-party processors and hospitals that..
http://www.fda.gov/bbs/topics/ANSWERS/ANS01027.html (score=72)

Guidance for Industry-ISSE
...This guidance represents the Agency's current thinking on industry-supported scientific.....The agency is providing this guidance to describe the agency's enforcement policy with.....The guidance seeks to clarify the distinction drawn by the agency between scientific and..
http://www.fda.gov/cder/guidance/isse.htm (score=72)

X:\TRANSFER\GUIDANCE\CLIN3.WPD
...This FDA guidance to industry provides suggestions on current approaches to studies in.....the case for all FDA guidance documents, suggestions are not requirements, but are offered.....progressed sufficiently to allow preparation of this guidance, additional work will be..
http://www.fda.gov/cder/guidance/clin3.pdf (score=72)

MQSA Guidance
...Draft guidance is published for public comment and is issued as final only after the.....Guidance is issued as final if it not new, complicated or controversial or has already.....Draft guidance documents that currently are open for public comment may be accessed by..
http://www.fda.gov/cdrh/mammography/guidance-rev.html (score=72)

510(k) Submissions for Coagulation Instruments - Guidance for Industry and...
...The issues identified in this guidance document represent those that we believe need to be.....specific risks to health associated with coagulation analyzers identified in this guidance.....This guidance document identifies the classification regulations and product codes for the..
http://www.fda.gov/cdrh/oivd/guidance/1223.pdf (score=72)

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...1 This guidance has been prepared by the Division of Counter-Terrorism and the Division of.....This guidance first summarizes appropriate nonclinical studies recommended during early.....Next, the guidance focuses on the acquisition of in vivo data through the use of animal..
http://www.fda.gov/cder/guidance/5518dft.pdf (score=71)

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