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Letters, Testimony & Comments

Comments regarding Changes to an Approved NDA or Abbreviated NDA
February 17, 2004
February 17, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No. 2000N-1449, Federal Register: December 19, 2003 (Volume 68, Number 244, Pages 70813-70815)...
2004 Special 301 Submission
February 13, 2004
BIO Testimony Opposing Hawaii House Bill 2034
February 12, 2004
Testimony of the Biotechnology Industry Organization Submitted to the House Economic Development and Business Concerns Committee February 12, 2004 Regarding House Bill 2034:The Prohibition of Bioprospecting on Public Lands On behalf of the...
BIO Testimony Opposing Hawaii House Bill 2034
February 12, 2004
HB 2034 proposes a ban on bioprospecting on public lands (Feb. 12, 2004).
Comments on Race and Ethnicity on MedWatch forms
February 6, 2004
Response to Notice 227 Patents Amendment Bill, 2004
February 5, 2004
Letter, Conference of the Parties of the Convention on Biological Diversity
February 5, 2004
Letter regarding the Conference of the Parties of the Convention on Biological Diversity
February 5, 2004
BIO/BayBIO/BIOCOMM
February 4, 2004
RE: Decision not to exempt transgenic ornamental fish from the resticted species list in Section 671, Title 14 California Code of Regulations Dear Mr. Flores: On behalf of BayBIO, BIOCOM and the Biotechnology Industry Organization (BIO), we...
BIO/BayBIO/BIOCOMM
February 4, 2004
Letter to California Fish and Game Commission: regarding a decision not to exempt transgenic ornamental fish from the restricted species list (Feb. 4, 2004).
BIO Comments on Pharmacogenomic Data Submissions
February 2, 2004
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...
Comments regarding Pharmacogenomic Data Submissions
February 2, 2004
February 2, 2004 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, Maryland 20852 Re: Docket No. 2003D-0497, Federal Register: November 4, 2003 (Volume 68, Number 213, Page 62461-62463) Dear...
BIO letter supporting the goals of H.R. 2391, the Cooperative Research and Technology Enhancement (CREATE) Act
January 21, 2004
BIO Comments on FDA's draft Guidance for Reviewers
December 22, 2003
On Providing Regulatory Submissions in Electronic Format - General Considerations.
Amgen v. Scully
December 12, 2003
Letter, Hon. Robert Zoellick, U.S. Trade Representative, in support of CAFTA
December 10, 2003
Letter from 30 Congressmembers urging Chairman Manzullo and Chairwoman Snowe to include a correction in SBA Reauthorization legislation (S. 1375/HR 2802)
December 10, 2003
Comments on FDA's draft Guidance for Reviewers
December 5, 2003
CMC for Human Somatic Cell Therapy INDs
Letter to James E. Rogan on Unity of Invention
December 5, 2003
Comments on FDA's draft Guidance for Industry
December 4, 2003
Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information.