| 2003D-0571 - Submitting Supporting Documentation in Drug Applications for the Manufacture of Drug Substances|
|FDA Comment Number :||EC1|
|Submitter :||Dr. Siegfried Throm||Date & Time:||06/10/2004 05:06:56|
|Organization :||German Assoc. of Research-Based Pharm. Companies|
| Dear Sirs
Please, find enclosed the VFA Comments on the draft "FDA Guidance for Industry - Drug substance - Chemistry, Manufacturing and Controls Information Draft Guidance - January 2004, Docket No. 2003D-0571".
The VFA represents the interests of 41 of the world`s leading research-based pharmaceutical companies in Germany. The VFA members, i.a. all the major US firms, make up about two-thirds of the German pharmaceutical market and are highly active in exporting drug substances and drugs i.a. into the US. Therefore VFA is very interested to actively contribute to the creation of adequate regulations covering these acitivities.
For further questions or comments please do not hesitate to contact us.
GERMAN ASSOCIATION OF RESEARCH-BASED PHARMACEUTICAL COMPANIES (VFA)
Dr. Siegfried Throm
Director Research, Development and Innovation
10117 Berlin / Germany