rBST
review (December 21, 1998)
Link of the
National Farmers Union of Canada, containing a Health Protection
Branch report on rBST and related documents.
Clinical
holds (December 21, 1998)
Final FDA
rule incorporating FDAMA requirements that the agency respond
to requests for removal of clinical holds.
Risk
assessment (December 21, 1998)
USDA call
for applications for Biotechnology Risk Assessment Research Grants.
Third
Party Reviews (November 2, 1998)
CDRH guidance
for "Implementation of Third Party Programs Under the FDA
Modernization Act of 1997" (PDF file)
Litigation
reform (PDF file) (October 19, 1998)
The Securities
Litigation Uniform Standards Act, passed last week by Congress.
Access
to Research Tools (August 31, 1998)
Report of
the NIH Working Group on Research Tools, pertaining to issues
involving scientific access to patented research tools, including
licensing, royalty and other topics.
HIV,
HTLV and Hepatitis Tests (July 20, 1998)
Updated list
of FDA licensed/approved tests for HIV, HTLV and hepatitis
User Fee
Plan (July 13, 1998)
Links to five
documents regarding FDA's five-year plan for implementing the
Prescription Drug User Fee Act II
Biotechnology
Patents (June 22, 1998)
Request for
comments on interim guidelines for complying with the "Written
Description'' requirement for biotechnological and other patent
applications.
Access
to Research Tools (June 15, 1998)
Report of
the NIH Working Group on Research Tools, pertaining to issues
involving scientific access to patented research tools, including
licensing, royalty and other topics
Cancer
Clinical Trials (May 11, 1998)
The National Cancer Institute's new website resource for cancer clinical
trials information.
Link
on Patent Policy (May
4, 1998)
Biomedical
"Privatization" � Articles and comments from Science
discussing the implications of patent policy on research tools
and other biomedical inventions.
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