Cystic
Fibrosis Foundation (November 24, 1997)
Link to the Cystic Fibrosis Foundation web site, which has information on
on-going clinical trials involving drugs and gene therapy.
FDA
Reading Room (November 10, 1997)
Link to FDA's "Reading Room" of electronic documents, including
transcripts of advisory committee meetings.
Law Enforced by
the FDA (November 3, 1997)
Compilation of the laws enforced by the FDA and related statutes.
In
Vitro Diagnostic Devices (November 3, 1997)
HHS manual
providing guidance for the preparation of 510(k) submissions,
covering premarket notification requirements for medical devices.
A
Natural System of Gene Families from Complete Genomes (October 27,
1997)
Link to COGs (clusters of orthologous groups) database developed by the
National Center for Biotechnology Information (NCBI) to identify functional
characteristics of unknown genes.
Pediatric
HIV (October 6, 1997)
Health Resources
and Services Administration (HRSA) request for comments on guidelines
for the use of antiretroviral agents in pediatric HIV infection.
International
Association of Physicians In AIDS Care (September 29, 1997)
Homepage for
the group advocating clinical trials of an HIV vaccine composed
of a live attenuated virus.
Stock
Options Accounting (May 27, 1997)
Text of S. 576, "The Ending Double Standards for Stock Options Act,"
introduced by Senators Carl Levin (D-Mich.) and John McCain (R-Ariz.).
See May 27, 1997 BioCentury for a complete story.
EPA
Office of Pollution Prevention and Toxics: Biotechnology Program
(March 3, 1997)
Link to a
new EPA web site focused on regulations, documents and status
reports pertaining to the OPPT's biotechnology program under the
Toxic Substances Control Act (TSCA).
Advanced Technology Program (ATP) homepage (February 24, 1997)
This link
includes an overview of the ATP program, and information about
how to apply for ATP grants.
FDA Guidance
on 510(k) Submissions (February 24, 1997)
Link to an
FDA guidance on "Deciding When to Submit a 510(k) for a Change
to an Existing Device"
2
Links to SBIR Program Documentation (February 3, 1997)
1. National
SBIR Conference Center Web Site. The latest news concerning SBIR
conferences and hot links to information about the National SBIR
Program.
2. The
NIH Office of Extramural Research: Small Business Funding Opportunities
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