Letters, Testimony & Comments

December 22, 2003
On Providing Regulatory Submissions in Electronic Format - General Considerations.
December 12, 2003
December 5, 2003
CMC for Human Somatic Cell Therapy INDs
December 4, 2003
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information.
November 19, 2003
The bill proposes a five year ban on open-air plantings of plant-made pharmaceuticals (Nov. 19, 2003).
November 17, 2003
Dear Sir/Madam: The following comments are provided by the Biotechnology Industry Organization (BIO). BIO represents more than 1,000 biotechnology companies, academic institutions, state biotechnology centers and related organizations in all 50...
November 5, 2003
November 5, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No. 2003D-0380, Federal Register: September 5, 2003 (Volume 68, Number 172, pp. 52781-52782...
November 5, 2003
November 4, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No. 2003D-0382, Federal Register: September 5, 2003 (Volume 68, Number 172, pp. 52782-52783...
November 4, 2003
To Hector Barreto, Administrator, U.S. Small Business Administration
November 3, 2003
November 3rd, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No. 2003N-0361, Federal Register: August 26, 2003 (Volume 68, Number 165, p. 51270) Dear...
October 24, 2003
Dear House Leadership: On behalf of the Biotechnology Industry Organization (BIO), I urge you to seek prompt passage of H.R. 1561, the United States Patent and Trademark Fee Modernization Act of 2003. This legislation would assist in enhancing...
October 21, 2003
To Hector Barreto, Administrator, U.S. Small Business Administration
October 13, 2003
October 13, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No. 00N-1484, Federal Register: March 14, 2003 (Volume 68, Number 50, Pages 12406-12497)...
September 25, 2003
Thanks very much. And thanks for giving me a good reason to come back to Texas. I love this state -mostly because it's built on energy. I don't mean oil. I mean entrepreneurial energy. If you've lived here a while, you may not feel how...
September 17, 2003
The Honorable James Greenwood 2436 Rayburn House Office Building U.S. House of Representatives Washington, DC 20515 The Honorable Anna Eshoo 205 Cannon House Office Building U.S. House of Representatives Washington, DC 20515 The...