testing (December 20, 1999)
of "public consultation" on the oversight of genetic tests.
studies (PDF file) (December
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
licensing (October 25, 1999)
rule, "Implementation of Biologics License; Elimination of Establishment
License and Product License".
Conference on Harmonisation (October 18, 1999)
Standards for the Transfer of Regulatory Information, prepared under
the auspices of theInternational Conference on Harmonisation (ICH).
Institute for Clinical Excellence (October 11, 1999)
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).
Central (September 7, 1999)
on its plans to create an internet repository for distribution of life
sciences research reports (see BioCentury, Sept. 7, 1999).
Manufacturing Practice (September 7, 1999)
of "Human Drug CGMP Notes", comprised of memos for FDA personnel
on GMP issues by FDA's Division of Manufacturing and Product Quality.
GMOs (July 19,1999)
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).
— 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).
drug benefit (June 28, 1999)
on "Considerations for a Medicare Prescription Drug Benefit",
provided to the Senate Finance Committee by representatives of the Biotechnology
Industry Organization and others.
trials disclosure (June 28, 1999)
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
publishing (June 14, 1999)
for Electronic Publications in the Biomedical Sciences" (see
story, BioCentury, June 14, 1999).
research (PDF file) (June 1, 1999)
legislation (S. 935) authorizing U.S. government research funding for
the conversion of biomass into "biobased" industrial products
(see BioCentury, June 1, 1999).
corn and other GM food issues (May 24,
GM regulation in Britain: U.K. House of Commons Science and Technology
Committee report: "Scientific Advisory System: Genetically Modified
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
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.
(April 12, 1999)
"Public Health Issues Posed by the Use of Nonhuman Primate Xenografts
in Humans" (see BioCentury, April 14, 1999).
negotiations (March 1, 1999)
of the Sixth Session of the Open-Ended Ad Hoc Working Group on Biosafety".
drugs (March 1, 1999)
List of all
products that are currently designated as orphans by FDA's Office of
Orphan Products Development.
vaccines (February 22, 1999)
of the December FDA-NCI workshop on tumor vaccines
labeling (January 25, 1999)
guidance, "Content and Format for Geriatric Labeling".