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Gilead Sciences Inc - Comment

Document ID: FDA-2013-D-0369-0002
Document Type: Public Submission
Agency: Food And Drug Administration
Received Date: June 05 2013, at 12:00 AM Eastern Daylight Time
Date Posted: June 6 2013, at 12:00 AM Eastern Standard Time
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
Tracking Number: 1jx-85qn-5e79
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This is comment on Notice

International Conference on Harmonisation; Draft Guidance on M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk; Availability

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Please find attached Gilead Sciences Inc.'s comments on this draft guidance. We thank the agency for the opportunity to comment.

Attachments:

Gilead Sciences FDA-2013-D-0369 GSI Comments final June 4 2013

Title:
Gilead Sciences FDA-2013-D-0369 GSI Comments final June 4 2013

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Total: 13

Sanofi - Comment
Public Submission Posted: 06/17/2013 ID: FDA-2013-D-0369-0005

Comment Period Closed
Jun 14,2013 11:59 PM ET

Gilead Sciences Inc - Comment
Public Submission Posted: 06/06/2013 ID: FDA-2013-D-0369-0002

Comment Period Closed
Jun 14,2013 11:59 PM ET

Merck & Co, Inc. - Comment
Public Submission Posted: 06/17/2013 ID: FDA-2013-D-0369-0012

Comment Period Closed
Jun 14,2013 11:59 PM ET

Eli Lilly and Company - Comment
Public Submission Posted: 06/17/2013 ID: FDA-2013-D-0369-0008

Comment Period Closed
Jun 14,2013 11:59 PM ET

Pfizer Inc. - Comment
Public Submission Posted: 06/17/2013 ID: FDA-2013-D-0369-0014

Comment Period Closed
Jun 14,2013 11:59 PM ET