PDF-Guidance for Industry 

Author : faustina-dinatale | Published Date : 2016-07-14

Clinical Trial Endpoints Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER ClinicalMedical Additional copies are available

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Guidance for Industry : Transcript


Clinical Trial Endpoints Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER ClinicalMedical Additional copies are available from Office of Trainin. Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be subm itted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Sub Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments on the draft guidance to http Comments and suggestions regarding this draft document should be submitted within 60 calendar days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Mana Federal Register Federal Register US Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER March 2014 ClinicalMedical 16617dftdoc 030614 brPage 2br Guidance for Industry Chronic Fatigue Sy Submit one set of either electronic or written comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Submit written omments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic comments to httpwwwregulationsgov Subm This guidance document has been revised to clarify our position on the use of clove oil as an anesthetic for fish This level 2 guidance document provides info rmation regarding the use of clove oil and its components as an anesthetic for fish Commen Comments and suggestions regarding this draft docu ment should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit comments to the Division of Dockets Management H Background. The NRC has a robust program to ensure remediation of radioactivity at NRC licensed power reactor sites. A number of power reactor sites have shutdown and gone into decommissioning, so there is significant industry experience with the process. (OECD Guidance). Due Diligence Audit. Content. Audit definition. Where to find auditors and further guidance. Audit definition. What is the audit process?. As defined in ISO 19011:2011—Guidelines for auditing management systems, an audit is a...

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