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1999 Links Archive
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These links take users to additional information, announcements, and government documents mentioned in BioCentury's publications.

Genetic testing (December 20, 1999)
NIH announcement of "public consultation" on the oversight of genetic tests.

Post-marketing studies (PDF file) (December 6, 1999)
Proposed FDA rule, "Postmarketing Studies for Human Drugs and Licensed Biological Products; Status Reports", describing the types of postmarketing studies covered by such status reports, the information to be included, and the type of information that FDA would consider appropriate for public disclosure.

Biologics licensing (October 25, 1999)
Final FDA rule, "Implementation of Biologics License; Elimination of Establishment License and Product License".

International Conference on Harmonisation (October 18, 1999)
Electronic Standards for the Transfer of Regulatory Information, prepared under the auspices of theInternational Conference on Harmonisation (ICH).

National Institute for Clinical Excellence (October 11, 1999)
U.K. National Institute for Clinical Excellence website. NICE provides guidance to the National Health Service (NHS) on the use, clinical benefits and costs of new and established health technologies (see BioCentury, Oct. 11, 1999).

PubMed Central (September 7, 1999)
NIH update on its plans to create an internet repository for distribution of life sciences research reports (see BioCentury, Sept. 7, 1999).

Good Manufacturing Practice (September 7, 1999)
Repository of "Human Drug CGMP Notes", comprised of memos for FDA personnel on GMP issues by FDA's Division of Manufacturing and Product Quality.

Airborne GMOs (July 19,1999)
Homepage for GeneWatch UK, which has issued a report about the release of genetically modified micro-organisms into rivers and the atmosphere (see BioCentury, July 19, 1999).

Science scares (June 28, 1999)
— GM food content: Websites for the Center for Ethics and Toxics who is contesting the alleged variability of phytoestrogen content in genetically modified soy (see BioCentury, June 28, 1999).

Medicare drug benefit (June 28, 1999)
Testimony on "Considerations for a Medicare Prescription Drug Benefit", provided to the Senate Finance Committee by representatives of the Biotechnology Industry Organization and others.

Device trials disclosure (June 28, 1999)
Request for comment by FDA's Center for Devices and Radiological Health (CDRH) regarding the feasibility of including information for device investigations for serious or life-threatening diseases and conditions in a public data bank.

Scientific publishing (June 14, 1999)
NIH "Proposal for Electronic Publications in the Biomedical Sciences" (see story, BioCentury, June 14, 1999).

Biomass research (PDF file) (June 1, 1999)
Proposed legislation (S. 935) authorizing U.S. government research funding for the conversion of biomass into "biobased" industrial products (see BioCentury, June 1, 1999).

Bt corn and other GM food issues (May 24, 1999)
GM regulation in Britain: U.K. House of Commons Science and Technology Committee report: "Scientific Advisory System: Genetically Modified Foods".

Sharing research resources (May 24, 1999)
NIH request for comments on "Principles for Recipients of NIH Research Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources" pertaining to the dissemination and use of proprietary research tools.

GMO policy (May 17, 1999)
U.K. Environmental Audit Committee's report, "Genetically Modified Organisms and the Environment: Coordination of Government Policy."

Product documentation (April 19, 1999)
— Biologics approval archives: CBER listing of product approval information arranged alphabetically by the proper name of the product.

Xenografts (April 12, 1999)
FDA guidance "Public Health Issues Posed by the Use of Nonhuman Primate Xenografts in Humans" (see BioCentury, April 14, 1999).

Biosafety negotiations (March 1, 1999)
"Report of the Sixth Session of the Open-Ended Ad Hoc Working Group on Biosafety".

Orphan drugs (March 1, 1999)
List of all products that are currently designated as orphans by FDA's Office of Orphan Products Development.

Tumor vaccines (February 22, 1999)
Transcript of the December FDA-NCI workshop on tumor vaccines

Geriatric labeling (January 25, 1999)
Draft FDA guidance, "Content and Format for Geriatric Labeling".

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