| Comment Record |
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Commentor |
Dr. Najib Sehat |
Date/Time |
2003-03-20 09:23:12 |
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Organization |
Merck KGaA |
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Category |
Company |
| Comments for FDA General |
| Questions |
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1. General Comments
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Dear Sir or Madam,
in general we aggree with the drafted implementation guidelines of the bioterrorism act of the US and all activities that might increase the general safety - especially in the supply chain of food and drugs.
However, as we were requested for comments and ideas due to an effective implementation of all necessary activities, we would like to ask the FDA to generate a system for a confidential handling of information.
We do have concerns to disclose all the manufacturers and traders of our substances directly to the customers as this transperancy of the complete market might lead to an abuse of information as well. We would encourrage a system that allows the direct submission of information to the FDA as it is for example already realized by the Drug Master Files-procedure.
Best regards
Najib Sehat
_____________________________
Dr. Najib Sehat
Merck KGaA
Life Science Products
Regulatory Affairs
Frankfurter Strasse 250
D-64293 Darmstadt
+49 (0)6151/72-6060
+49 (0)6151/72-916060
E-Mail: Najib.Sehat@merck.de
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