144K - views

Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses Recommended Practices REVISED DRAFT GUIDANCE This guidance document is being distributed for comment purpo

Published bycalandra-battersby

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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic com ments to httpwwwregulationsgov Su

Tags : Comments and suggestions regarding
Embed :
Pdf Download Link

Download Pdf - The PPT/PDF document "Guidance for Industry Distributing Scien..." is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.

Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses Recommended Practices REVISED DRAFT GUIDANCE This guidance document is being distributed for comment purpo






Presentation on theme: "Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses Recommended Practices REVISED DRAFT GUIDANCE This guidance document is being distributed for comment purpo"— Presentation transcript:

pdf

Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New Uses Recommended Practices REVISED DRAFT GUIDANCE This guidance document is being distributed for comment purpo - Description

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be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance Submit electronic com ments to httpwwwregulationsgov Su ID: 9697 Download Pdf

Similar presentations

Guidance for Industry How to Comply with the Pediatric Research Equity Act DRAFT GUIDANCE This guidance document is being distributed for comment purposes only
Guidance for Industry How to Comply with the Pediatric Research Equity Act DRAFT GUIDANCE This guidance document is being distributed for comment purposes only

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

Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only
Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE This guidance document is being distributed for comment purposes only

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

ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only
ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits Guidance for Industry DRAFT GUIDANCE This guidance document is being distributed for comment purposes only

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

Informed Consent Information Sheet Guidance for IRBs Clinical Investigators and Sponsors DRAFT GUIDANCE This guidance document is being distributed for comment purposes only
Informed Consent Information Sheet Guidance for IRBs Clinical Investigators and Sponsors DRAFT GUIDANCE This guidance document is being distributed for comment purposes only

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

Guidance for Industry Developing Products for Weight Management DRAFT GUIDANCE This guidance document is being di stributed for comment purposes only
Guidance for Industry Developing Products for Weight Management DRAFT GUIDANCE This guidance document is being di stributed for comment purposes only

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 comments to the Division of Dockets Management HF

Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use Qs As DRAFT GUIDANCE This guidance document is being di stributed for comment purposes only
Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use Qs As DRAFT GUIDANCE This guidance document is being di stributed for comment purposes only

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

Guidance for Industry Complicated Intra Abdominal Infections Developing Drugs for Treatment DRAFT GUIDANCE This guidance document is being di stributed for comment purposes only
Guidance for Industry Complicated Intra Abdominal Infections Developing Drugs for Treatment DRAFT GUIDANCE This guidance document is being di stributed for comment purposes only

5741157455574535745357445574545746057459573765744157454574445737657459574615744757447574455745957460574495745557454574595737657458574455744757441574585744457449574545744757376574605744857449574595737657444574585744157446574605737657444

Guidance for Industry Contract Manufacturing Arrangements for Drugs Quality Agreements DRAFT GUIDANCE This guidance document is being di stributed for comment purposes only
Guidance for Industry Contract Manufacturing Arrangements for Drugs Quality Agreements DRAFT GUIDANCE This guidance document is being di stributed for comment purposes only

Comments and suggestions regarding this draft document should be submitted within 60 days of publication in the Federal Register of the not ice announcing the availa bility of the draft guidance Submit electronic comments to httpwwwregulationsgov S

Guidance for Industry Considerations for the Design of Early Phase Clinical Trials of Cellular and Gene Therapy Products DRAFT GUIDANCE This guidance document is for comment purposes only
Guidance for Industry Considerations for the Design of Early Phase Clinical Trials of Cellular and Gene Therapy Products DRAFT GUIDANCE This guidance document is for comment purposes only

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

Guidance for Industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors DRAFT GUIDANCE This guidance document is being di stributed for comment pur
Guidance for Industry Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors DRAFT GUIDANCE This guidance document is being di stributed for comment pur

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