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2001 Links Archive
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These links take users to additional information, announcements, and government documents mentioned in BioCentury's publications.

Conflict of interest (PDF file) (December 24, 2001)
General Accounting Office report to Sen. Bill Frist (R-Tenn.) on "HHS Direction Needed to Address Financial Conflicts of Interest" in biomedical research.

Drug import-export (PDF files) (December 24, 2001)
Final FDA rule on the export of products that may not be marketed or sold in the U.S.

Bioterrorism (December 17, 2001)
Outline of seven new programs at HHS to accelerate bioterrorism research.

Stem cells (December 17, 2001)
NIH grant programs to increase the number and enhance the quality of human embryonic stem cells available to researchers, and for studies on the plasticity and behavior of human stem cells (see BioCentury Extra, Tuesday Dec. 11, 2001).

Product documentation (December 17, 2001)
PEG-Intron: Briefing documentation for the Dec. 12, 2001, meeting of the FDA’s Antiviral Drugs Advisory Committee for a post-review update of PEG-Intron powder to treat chronic hepatitis C, from Schering-Plough Corp. (SGP) and Enzon Corp. (ENZN).

PDUFA (December 10, 2001)
FDA's Prescription Drug User Fee Act web page, with links to the text of the law and performance and financial reports (see BioCentury, Dec. 10, 2001).

Product Information (December 10, 2001)
Camptosar: Briefing documentation for the Dec. 6, 2001, meeting of the FDA’s Oncologics Drugs Advisory Committee to discuss post-marketing safety issues for Camptosar irinotecan hydrochloride injection combined with 5FU/leucovorin to treat metastatic colorectal cancer, from Pharmacia Corp. (PHA).
Gliadel: Briefing documentation for the Dec. 6, 2001, meeting of the FDA’s Oncologics Drugs Advisory Committee review of the sNDA for Gliadel wafer carmustine to treat malignant glioma, from Guilford Pharmaceuticals Inc. (GLFD).
Herceptin: Briefing documents for the Dec. 5, 2001, meeting of the FDA’s Oncologic Drugs Advisory Committee review of the sBLA to add a fluorescence in situ hybridization (FISH) assay to the label for Herceptin trastuzumab to treat metastatic breast cancer, from Genentech Inc. (DNA).

Data monitoring (December 3, 2001)
Presentations from the Nov. 27, 2001, workshop on the FDA’s guidance on clinical trial data monitoring committees.

Foreign registration (PDF file) (December 3, 2001)
Final FDA rule for foreign establishment registration and listing of human drugs, animal drugs, biological products and devices.

Labeling (December 3, 2001)
FDA notice that it has reopened the comment period regarding its draft guidance on the content and format section of the clinical studies section of labeling for prescription drugs and biologics, and a link to the draft guidance (PDF file).

Manufacturing (December 3, 2001)
FDA briefing documents for the Nov. 28, 2001, meeting of the agency’s Advisory Committee for Pharmaceutical Science.

Papillomavirus (HPV) (December 3, 2001)
Briefing documents for the Nov. 28-29, 2001, meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee to discuss possible endpoints for licensure of human papillomavirus vaccines.

PDUFA (December 3, 2001)
— FDA background documents for Dec. 7 agency meeting with stakeholders to discuss provisions to the Prescription Drug User Fee Act (PDUFA).

Pediatric trials (PDF file) (December 3, 2001)
FDA questions for the Nov. 28, 2001, meeting of the Pediatric Subcommittee of the Oncologic Drugs Advisory Committee to discuss implementation of the Pediatric Rule of 1998 with regard to study type and design.

Product documentation (December 3, 2001)
Gynecare: FDA review information for Gynecare Intergel to prevent adhesions, from Lifecore Biomedical Inc. (LCBM).

Pediatric drugs (PDF file) (November 19, 2001)
H.R. 2887, passed by the U.S. House of Representatives to reauthorize the pediatric exclusivity provisions of the FDA Modernization Act (see BioCentury, Extra Nov. 16).

Preclinical assessment (November 12, 2001)
Briefing documents for the Nov. 13, 2001 meeting of the nonclinical studies subcommittee of the FDA’s Advisory Committee on Pharmaceutical Science, which is focused on the improvement of the design and application of laboratory-based studies for safety and efficacy assessments.

Stem cells (November 12, 2001)
The NIH Human Embryonic Stem Cell Registry (see BioCentury Extra, Thursday Nov. 8, 2001).

Product documentation (November 5, 2001)
— Beta interferons: Technology appraisal web page by the U.K.’s National Institute for Clinical Excellence (NICE) for the use of beta Interferons and glatiramer to treat multiple sclerosis.
Dermagraft: FDA review documents for Dermagraft human fibroblast skin substitute to treat diabetic foot ulcers, from Advanced Tissue Sciences Inc. (ATIS).

FDA guidance (PDF file) (October 29, 2001)
FDA’s annual comprehensive list of guidance documents.

TSE (October 29, 2001)
— Briefing documents for the FDA’s Transmissable Spongiform Encephalopathies Advisory Committee Oct. 25, 2001, meeting on Creutzfeldt-Jakob Disease (CJD), Variant Creutzfeldt-Jakob Disease (vCJD) and Bovine Spongiform Encephalopathy (BSE).
— Briefing documents for the FDA’s Transmissable Spongiform Encephalopathies Advisory Committee Oct. 26, 2001, meeting on bovine brain, spinal cord, and other neurological tissue in foods, drugs and cosmetics for human use

GM corn (October 22, 2001)
"The StarLink Case: Issues for the Future," a report form the Pew Initiative on Food and Biotechnology.

Industry & the Public (October 22, 2001)
The Affordable Prescription Drugs and Medical Inventions Act (HR 1708), authored by Rep. Sherrod Brown (D-Ohio). (see BioCentury, Oct. 22, 2001). (PDF file)

Registration (PDF files) (October 22, 2001)
FDA guidance, "Organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use," prepared under the auspices of the International Conference on Harmonisation.
— M4: Organization of the CTD
— M4: The CTD — Quality
— M4: The CTD — Efficacy
— M4: The CTD — Safety
— M4: The CTD — Safety Appendices

Product documentation (October 22, 2001)
Xigris: FDA briefing documents the Oct. 16, 2001, Anti-Infective Drugs Advisory Committee Review of Xigris drotrecogin alfa to treat sepsis, from Eli Lilly and Co. (LLY).

Pediatric exclusivity (PDF file) (October 15, 2001)
H.R. 3047, the "Best Pharmaceuticals for Children Act" (see BioCentury, Oct. 15, 2001).

Product Documentation (October 15, 2001)
Diovan: Briefing document for the Cardiovascular and Renal Drugs Advisory Committee review of Diovan valsartan to treat congestive heart failure, from Novartis Pharmaceuticals Corp. (see BioCentury Extra, Thursday Oct. 11, 2001). (PDF file)
QuantiFERON-TB: Briefing documents for the Oct. 12, 2001, FDA Microbiology Devices Panel review of QuantiFERON-TB in vitro diagnostic device as an aid in the diagnosis of latent tuberculosis infection, from Cellestis Ltd.
Endotoxin Activity: CDRH PMA documents for Endotoxin Activity Assay, an in vitro diagnostic to determine endotoxin activity in human blood samples, to rule out Gram negative infection, from Sepsis Inc.

Bioterrorism (PDF files) (October 8, 2001)
— U.S. General Accounting Office report, "Bioterrorism: Federal Research and Preparedness Activities" (see BioCentury, Oct. 8, 2001).

Multiple sclerosis (October 8, 2001)
Progress report on the U.K. National Institute of Clinical Excellence (NICE) appraisal of beta interferon and glatiramer acetate for multiple sclerosis (see BioCentury, Aug. 13, 2001).

NIH funding (October 8, 2001)
NIH announcement of $45 million in funds for biomedical research infrastructure networks, benefiting institutions in states with low participation in past NIH funding efforts.

Product Documentation (October 8, 2001)
Vfend: FDA briefing documents for the Oct. 4, 2001, Antiviral Drugs Advisory Committee review of Vfend voriconazole to treat invasive aspergillosis, serious Candida infections, and other infections, from Pfizer Inc. (PFE).
Viread: FDA briefing documents for the Oct. 3, 2001, Antiviral Drugs Advisory Committee review of Viread tenofovir to treat AIDS, from Gilead Sciences Inc. (GILD) (see BioCentury, Oct. 8, 2001).

Pediatric exclusivity (PDF file) (September 24, 2001)
H. R. 2887, introduced by Rep. Jim Greenwood (R-Penn.), to amend the Federal Food, Drug, and Cosmetic Act to improve the safety and efficacy of pharmaceuticals for children (see BioCentury Extra, Tuesday Sept. 18, 2001)..

Harmonization (PDF file) (September 17, 2001)
FDA notice of a public meeting on Oct. 1 to discuss preparation for Global Harmonization Task Force Conference in Barcelona, Spain.

Product documentation (September 17, 2001)
XiGris: FDA briefing documents for the Anti-Infective Advisory Committee review of XiGris drotrecogin alfa to treat severe sepsis, from Eli Lilly and Co. Note: The meeting, originally scheduled for Sept. 12, has been postponed to a later date (see BioCentury, Sept. 17, 2001). (PDF file)
— Zevalin: FDA review and company briefing documents, with erratum (1) (2) (3), for the Sept. 11, 2001, review of Zevalin ibritumomab tiuxetan to treat relapsed or refractory low grade, follicular or CD20+ transformed B cell non-Hodgkin’s lymphoma, from IDEC Pharmaceuticals Corp. (IDPH) (see BioCentury, Sept. 17, 2001). (PDF files)

Opiates (September 10, 2001)
FDA briefing documents for Sept. 13-14, 2001 meeting of the Anesthetic and Life Support Drugs Advisory Committee to discuss opiate analgesics.

Product documentation (September 10, 2001)
IntraDose: FDA briefing documents for the Sept. 10, 20001, Oncologic Drugs Advisory Committee review of IntraDose cisplatin/epinephrine to treat squamous cell carcinoma of the head and neck, from Matrix Pharmaceutical Inc. (MATX).
Kineret: FDA briefing for the Aug. 16, 2001, Arthitis Drugs Advisory Committee review of Kineret anakinra to treat rheumatoid arthritis, from Amgen Inc. (AMGN).— FDA notice of "Copies of Presiding Officer Reports and Commissioner Decisions on the Eligibility of a Clinical Investigator to Continue to Receive Investigational Products," plus a link to the accompanying index and reports.

Orphan drugs (PDF file) (September 4, 2001)
FDA announcement of expected fiscal 2002 grants to support clinical trials of products for a rare disease or condition.

Clinical trials (August 27, 2001)
— New FDA website, "Good Clinical Practice in FDA-Regulated Clinical Trials," containing clinical trial background and information, including guidances, regulations, and how to report complaints.

Pain products (August 27, 2001)
Briefing documents for the Sept. 13-14 meeting of the FDA’s Anesthetic and Life Support Drugs Advisory Committee on Opiate Analgesics."

Manufacturing (PDF file) (August 20, 2001)
Draft FDA guidance, "Biological Product Deviation Reporting for Licensed Manufacturers of Biological Products Other Than Blood and Blood Components,'' in which the safety, purity, or potency of a distributed product may be affected.

Tissue products (PDF file) (August 20, 2001)
Announcement of Aug. 29 workshop, "FDA Tissue Reference Group—The Process," pertaining to the use of the TRG by sponsors to address issues of jurisdiction, policy, and regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps).

Product documentation (August 20, 2001)
Enbrel/Remicade: Briefing documents for FDA Arthritis Advisory Committee review of side effects associated with TNF blockers Enbrel etanercept and Remicade infliximab to treat rheumatoid arthritis, from Immunex Corp. (IMNX) and Centocor Inc., respectively (see BioCentury, Aug. 20, 2001).
Kineret: Briefing data for the Arthritis Advisory Committee review of Kineret anakinra to treat rheumatoid arthritis, from Amgen Inc. (AMGN) (see BioCentury, Aug. 20, 2001).

Product documentation (July 30, 2001)
FluMist: FDA and company briefing documents for the Vaccines and Related Biological Products Advisory Committee review of FluMist cold adapted influenza vaccine for the prevention of influenza in children, adolescents and adults, from Aviron (AVIR) (see BioCentury, July 30, 2001).
Symlin: FDA and company briefing documents for the Endocrinologic and Metabolic Drugs Advisory Committee review of Symlin pramlintide to treat Diabetes Type I and Type II, from Amylin Pharmaceuticals Inc. (AMLN) (see BioCentury, July 30, 2001).

Johns Hopkins (July 23, 2001)
FDA Inspectional Observations report from June 28, 2001, regarding the Johns Hopkins Asthma & Allergy Clinic (see BioCentury Extra, Friday July 20, 2001).

Clinical trials (PDF file) (July 16, 2001)
Updated draft FDA guidance, "Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Implementation Plan", pertaining to submissions of information to the Clinical Trials Data Bank required by the FDA Modernization Act of 1997.

Pharmacology (PDF file) (July 16, 2001)
International Conference on Harmonisation guidance on topic S7A, "Safety Pharmacology Studies for Human Pharmaceuticals."

Labeling (PDF file) (July 9, 2001)
Draft FDA guidance, "Clinical Studies Section of Labeling for Prescription Drugs and Biologics-Content and Format."

StarLink corn (June 25, 2001)
FDA and CDC reports to the EPA on alleged allergic reactions to Cry9C protein in StarLink corn (see BioCentury Extra, Thursday June 14).

Therapeutic cloning (June 25, 2001)
— H.R. 1644, the "Human Cloning Prohibition Act of 2001,’’ introduced in the U.S. House of Representatives by Rep. Dave Weldon (R-Fla.) and Bart Stupak (D-Mich.). (PDF file)
— H.R. 2172, the "Cloning Prohibition Act of 2001,’’introduced by Rep. James Greenwood (R-Penn.) (see BioCentury, June 25, 2001). (PDF file)

Patents (PDF file) (June 18, 2001)
"A Patent Policy Proposal for Global Diseases", examining the rationale for differential patent protection for drugs in developing nations, published by The Brookings Institution (see BioCentury, June 18, 2001).

Product documentation (June 11, 2001)
— Xyrem: Briefing information and panel questions for the June 6, 2001, FDA Peripheral & Central Nervous System Drugs Advisory Committee review of Xyrem sodium oxybate to reduce the incidence of cataplexy and to improve the symptom of daytime sleepiness for persons with narcolepsy, from Orphan Medical Inc. (ORPH) (see BioCentury, June 11, 2001).

Arthritis (PDF file) (May 29, 2001)
FDA request for assistance on clinical development programs for drugs, biologicals, and devices to treat ankylosing spondylitis (AS – an arthritic condition) and related disorders.

Cholesterol (May 29, 2001)
Guidelines from the National Cholesterol Education Program of the National Heart, Lung and Blood Institute: "Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)" (see BioCentury, May 29, 2001).

Market exclusivity (PDF file) (May 29, 2001)
FDA request for comment on "Issues Associated With the Intersection of 180-Day Generic Drug Exclusivity and Pediatric Exclusivity."

User fees (PDF file) (May 29, 2001)
FDA update of its five-year plan for implementing the Prescription Drug User Fee Act (PDUFA), with updated projections for fiscal 2001 and 2002.

Product documentation (May 29, 2001)
— Natracor: Company and FDA briefing documents, and the agency questions (PDF file) for the Cardiovascular & Renal Drugs Advisory Committee review of Natrecor nesiritide to treat decompensated congestive heart failure (CHF), from Scios Inc. (SCIO) (see BioCentury, May 29, 2001).
— Ketek: Company and FDA briefing documents, slide presentations and the transcript of the April 26, 2001, Anti-Infective Drugs Advisory Committee review of Ketek telithromycin to treat respiratory tract infections, from Aventis S.A. (AVE).

Control groups (PDF file) (May 21, 2001)
FDA guidance prepared under the auspices of the International Conference on Harmonisation (ICH), "El0 Choice of Control Group and Related Issues in Clinical Trials."

Price controls (May 21, 2001)
Ruling by the U.S. Court of Appeals in the suit by the Pharmaceutical Research and Manufacturers of America (PhRMA) against the state of Maine (see BioCentury, May 21, 2001).

Academic publishing (May 14, 2001)
Web site debates on scientific publishing (see BioCentury, May 14, 2001).
Public Library of Science
Science Magazine's online forum on e-publishing
Nature's online debate on web publishing

Advisory committees (PDF file) (May 14, 2001)
FDA request for nominations for members for CDER advisory committees.

Adverse events (PDF file) (May 7, 2001)
FDA notice correcting its previous announcement of funding for studies of adverse effects of marketed drugs.

FDAMA (May 7, 2001)
Draft FDA guidance, "The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles'', pertaining to agency interpretation FDAMA requirements that it take into account the least burdensome means for applicants to demonstrate a device's effectiveness or substantial equivalence.

Hepatitis C (PDF file) (May 7, 2001)
Draft FDA guidance, "Premarket Approval Applications for In Vitro Diagnostic Devices Pertaining to Hepatitis C Viruses (HCV); Assays Intended for Diagnosis, Prognosis, or Monitoring of HCV Infection, Hepatitis C, or Other HCV-Associated Disease".

Natural products (PDF file) (May 7, 2001)
FDA notice of a single source cooperative agreement to support the National Center for Natural Products Research (NCNPR) at the University of Mississippi.

Pediatric studies (PDF file) (May 7, 2001)
Interim FDA rule, "Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products".

Product promotion (PDF file) (May 7, 2001)
Draft FDA guidance, "Using FDA-Approved Patient Labeling in Consumer-Directed Print Advertisements".

Fast track (April 30, 2001)
Center for Drug Evaluation and Research (CDER) reports on their Fast Track performance since March 1998.

IND disclosure (April 30, 2001)
— Proposed FDA rule: "Human drugs and biological products: Human gene therapy or xenotransplantation; data and information disclosure." (PDF file)

Dietary supplements (April 23, 2001)
— HHS Inspector General report, "Adverse Event Reporting System for Dietary Supplements: An Inadequate Safety Valve" (see BioCentury, April 23, 2001). (PDF file)

Product documentation (April 23, 2001)
Aslera: Briefing documents and questions for the FDA Arthritis Advisory Committee meeting on April 19, 2001, to review Aslera prasterone to treat systemic lupus erythematosus in women, from Genelabs Technologies Inc. (GNLB) (see BioCentury, April 23, 2001).

GM foods (PDF file) (April 16, 2001)
Court ruling in Monsanto Canada Inc. v. Percy Schmeiser (see BioCentury, April 16, 2001). (PDF file)
— A website defending Percy Schmeiser

Adverse events (PDF file) (April 9, 2001)
FDA notices of availability of grants to study adverse effects of marketed drugs.

GM foods (PDF file) (April 9, 2001)
FDA notice that it is extending the comment period on its proposed rule for premarket notice concerning bioengineered foods.

Post-marketing studies (PDF file) (April 9, 2001)
Draft FDA guidance, "Reports on the Status of Postmarketing Studies – Implementation of Section 130 of the Food and Drug Administration Modernization Act of 1997".

Cloning (April 2, 2001)
— H.R. 1260, to prohibit the cloning of humans, introduced by Rep. Brian Kerns, (R-Ind.).

Conflict of interest (April 2, 2001)
FDA guidance on "Financial Disclosure by Clinical Investigators" (see BioCentury Extra, Tuesday March 27, 2001).

Drug labeling (PDF file) (April 2, 2001)
FDA notice reopening the comment period on its proposed rule on "Requirements on Content and Format of Labeling for Human Prescription Drugs and Biologics".

Advertising (PDF file) (March 19, 2001)
FDA request for comments on plans to assess physician and patient attitudes toward direct-to-consumer promotion of prescription drugs.

PMA notices (PDF file) (March 19, 2001)
FDA list of approved premarket approval applications (PMAs).

Safety reporting (PDF file) (March 19, 2001)
Draft FDA guidance on "Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines".

Clinical trials (PDF file) (March 12, 2001)
FDA guidance, "Acceptance of Foreign Clinical Studies".

Drug safety (PDF file) (March 12, 2001)
Draft FDA guidance on "Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines".

Dietary supplements (PDF file) (February 26, 2001)
FDA request for comments on the information that should be included in a guidance on applying the regulations on structure/function claims made for dietary supplements.

User fees (PDF file) (February 26, 2001)
Draft FDA guidance, "Separate Marketing Applications and Definition of Clinical Data for Purposes of Assessing User Fees".

Human genome project (February 12, 2001)
"Human Genome Project Working Draft" website at the University of California, Santa Cruz (see BioCentury, Feb. 12, 2001).

Xenotransplant (PDF file) (February 12, 2001)
Draft FDA guidance, "Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans".

London Stock Exchange (PDF file) (February 5, 2001)
U.K. Financial Services Authority "Proposed changes to the Listing Rules", including Chapter 20 listings affecting scientific research-based companies (see BioCentury, Feb. 5, 2001).

Xenotransplant (PDF file)
HHS document, "PHS Guideline on Infectious Disease Issues in Xenotransplantation".

Advisory committees (January 29, 2001)
Final FDA rule for disclosure of documents provided for use by advisory committees prior to or at the time of a panel meeting (see BioCentury, Jan. 29, 2001).

Bioengineered foods (January 22, 2001)
EPA notice that Aventis CropScience has requested cancellation of registration of Bacillus thuringiensis (B.t.) subspecies tolworthi Cry9C and the genetic material necessary for its production in StarLink corn.

Gene patents (January 8, 2001)
Revised U.S. Patent and Trademark Office guidelines for use in assessing "utility" requirements for gene patenting, and revised PTO guidelines for assessing the "written description" requirements (see BioCentury, Jan. 8, 2001).

Women’s health (January 8, 2001)
Report on the scientific research program of the FDA’s Office of Women's Health.

Chemical substances (PDF file) (January 2, 2001)
FDA guidance on "Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, prepared under the International Conference on Harmonisation (ICH).

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