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Home » Rulemaking » International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Availability

International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Availability

Document ID: FDA-2013-D-0369-0001
Document Type: Notice
Agency: Food And Drug Administration
Topics: No Topics associated with this document
Federal Register Number: 2013-08723
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Details Information

Document Subtype: Notice of Availability
Received Date: April 15 2013, at 12:00 AM Eastern Daylight Time
Start-End Page: 22269 - 22270
Page Count: 2
Comment Start Date: April 15 2013, at 12:00 AM Eastern Standard Time
Comment Due Date: June 14 2013, at 11:59 PM Eastern Standard Time

Comments

    View All
Total: 13
Sanofi - Comment
Posted: 06/17/2013     ID: FDA-2013-D-0369-0005

Jun 14,2013 11:59 PM ET
Gilead Sciences Inc - Comment
Posted: 06/06/2013     ID: FDA-2013-D-0369-0002

Jun 14,2013 11:59 PM ET
Merck & Co, Inc. - Comment
Posted: 06/17/2013     ID: FDA-2013-D-0369-0012

Jun 14,2013 11:59 PM ET
Eli Lilly and Company - Comment
Posted: 06/17/2013     ID: FDA-2013-D-0369-0008

Jun 14,2013 11:59 PM ET
Pfizer Inc. - Comment
Posted: 06/17/2013     ID: FDA-2013-D-0369-0014

Jun 14,2013 11:59 PM ET

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