Product documentation (December 18, 2000)
� Femara: FDA reviews and company briefing documents for Femara letrozole as a first line treatment for breast cancer, from Novartis Pharmaceuticals Corp. (Note: Documents located at top of linked page).
� Maxamine: FDA reviews and company briefing documents for Maxamine histamine hydrochloride for use in metastatic melanoma, from Maxim Pharmaceuticals Inc. (MAXM; SSE:MAXM) (Note: Documents located at bottom of linked page) (see BioCentury, Dec. 18, 2000).

User fees (PDF file) (December 18, 2000)
FDA announcement of prescription drug user fee rates for fiscal 2001

Pediatric drugs (PDF file) (December 4, 2000)
Draft FDA guidance on "Recommendations for Complying With the Pediatric Rule".

Gene therapy (November 20, 2000)
Briefing documents for the meeting of the FDA’s Biological Response Modifiers Advisory Committee on Nov. 16-17, 2000, to discuss oversight and long-term tracking of gene therapy clinical trial subjects (see BioCentury, Nov. 20, 2000).

Gene therapy (November 13, 2000)
Agenda (PDF file) and briefing documents for Nov. 16-17 meeting of the FDA’s Biological Response Modifiers Advisory Committee to discuss issues related to clinical trials of gene therapies.

Biologics manufacturing (PDF file) (November 6, 2000)
Final FDA rule, "Biological Products: Reporting of Biological Product Deviations in Manufacturing".

Small business assistance (November 6, 2000)
Center for Drug Evaluation and Research (CDER) website for small business assistance.

Maine drug rebates (PDf file) (October 30, 2000)
Preliminary injunction issued by the U.S. District Court in the action by the Pharmaceutical Research and Manufacturers of America (PhRMA) against the state of Maine (see BioCentury Extra, Friday Oct. 27, 2000).

Biological patents (PDF file) (October 23, 2000)
U.S. Government Accounting Office (GAO) report, "Intellectual Property: Deposits of Biological Materials in Support of Certain Patent Applications", investigating the risk to the biotech industry of biological deposits made in connection with patent grants.

Electronic regulatory submissions (July 10, 2000)
CDER’s Electronic Regulatory Submissions and Review homepage.

Medicare & clinical trials (June 12, 2000)
Institute of Medicine of the National Academy of Sciences report on "Extending Medicare Reimbursement in Clinical Trials", with recommendations for Medicare clinical trial reimbursement (see BioCentury, June 12, 2000).

Access to drugs (May 22, 2000)
Materials from an on-line conference "Anti-Retroviral (ARV) Treatment in Developing Countries: Questions of Economics, Equity and Ethics", hosted by the AIDS Economics web site and sponsored by UNAIDS and The World Bank (see BioCentury, May 22, 2000).

Prince Charles on progress (May 22, 2000)
The Reith Lecture by the Prince of Wales, including comments on reengineering nature and the precautionary principle (see BioCentury, May 22, 2000).

White House prescription drug plan (May 15, 2000)
Congressional testimony by William Scanlon (PDF file), director of health financing and public health issues at the General Accounting Office (GAO), and by Dan Crippen, director of the Congressional Budget Office (CBO), on the Clinton administration’s Medicare prescription drug proposal (see BioCentury, May 15, 2000).

Advisory panel documentation (May 15, 2000)
Agenda (PDF file) and briefing documents for the May 11-12, 2000 meeting of the FDA’s Vaccines and Related Biologicals Products Advisory Committee.

GM foods regulation (May 8, 2000)
Clinton administration announcements on oversight of genetically modified foods (see BioCentury, May 8, 2000, & BioCentury Extra, Wednesday, May 3, 2000).
� USDA announcement on plans to standardize identification of biotechnology-derived grains.

Accelerated approvals (May 1, 2000)
Updated list of sNDAs receiving accelerated at FDA.

Biotechnology, food safety & nutrition (April 24, 2000)
Remarks by Secretary of Agriculture Dan Glickman to the Consumer Federation of America 2000 National Food Policy Conference (see BioCentury, April 24, 2000).

Product safety (April 17, 2000)
New CBER web page consolidating product safety announcements.

NAS report on GM plants (April 10, 2000)
National Academy of Sciences report on "Genetically Modified Pest Protected Plants" (see BioCentury Extra, Wednesday April 5, 2000 & BioCentury, April 10, 2000).

Product safety (April 10, 2000)
New CBER web page consolidating product safety announcements.

Islet cell transplantation (April 3, 2000)
Agenda and briefing documents for the March 20 meeting of the Biological Response Modifiers Advisory Committee, to discuss islet cell transplantation.

Product documentation (March 20, 2000)
� Mylotarg: Review documents and presentations for March 17, 2000, FDA Oncologic Drugs Advisory Committee review of Mylotarg (gemtuzumab zogamicin) for relapsed acute myelogenous leukemia, from Wyeth-Ayerst Research and Celltech Group plc (LSE:CCH; CLL) (see BioCentury, March 20, 2000).

Biotech foods & society (see BioCentury, March 13, 2000) (March 13, 2000)
� "Agricultural Biotechnology and the Poor", proceedings from a World Bank conference organized by the Consultative Group on International Agricultural Research (CGIAR) and the National Academy of Sciences (NAS), and cosponsored by: the Biotechnology Industry Organization (BIO), among others.
� Third Report of the UK Agriculture Select Committee: The Segregation of Genetically Modified Foods. Vol. 1: Report & Proceedings; Vol. 2: Evidence & Appendicies

Off-label regulation (March 6, 2000)
Ruling by U.S. Court of Appeals in the suit by the Washington Legal Foundation challenging FDA’s regulation of the dissemination of information about off-label drug use (see BioCentury, March 6, 2000).

NIH clinical trials database (March 6, 2000)
NIH’s ClinicalTrials.gov database on more than 4,000 federal and private clinical studies (see BioCentury Extra, Feb. 29, 2000).

NDA submissions (PDF file) (February 28, 2000)
Detailed FDA checklist for submitting electronic NDAs.

Price controls/Prescription drugs (February 22, 2000)
� Congressional testimony by the General Accounting Office on Medicare prescription drug benefits. (PDF file)

St. John’s wort warnings (February 14, 2000)
� NIH announcement, "Clinical Center Study Demonstrates Dangerous Interaction between St. John's wort and an HIV Protease Inhibitor".

Transdermal Drugs (February 7, 2000)
FDA guidance, "Skin Irritation and Sensitization Testing of Generic Transdermal Drug Products".

Product documentation (January 31, 2000)
� Intergel: Transcript of the Jan. 12 FDA General and Plastic Surgery Devices Panel review of Intergel ferric hyaluronate adhesion prevention solution, from Lifecore Biomedical Inc. (LCBM).
� Novantrone: FDA advisory committee briefing information for Novantrone mitoxantrone to treat multiple sclerosis, from Immunex Corp. (IMNX) (see BioCentury Jan. 31, 2000).

Xenotransplantation(January 31, 2000)
Transcript of the Jan. 13 meeting of the xenotransplantation subcommittee of the FDA's Biological Response Modifiers Advisory Committee (see BioCentury, Jan. 17, 2000).

Xenotransplant (January 24, 2000)
CBER "Action Plan" outlining FDA's approach to the regulation of xenotransplantation

Xenotransplantation (January 17, 2000)
Briefing documents for the Jan. 13 meeting of the xenotransplantation subcommittee of the FDA's Biological Response Modifiers Advisory Committee (see BioCentury, Jan. 17, 2000).

Dietary supplements (January 10, 2000)
Final FDA rule on "Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body" (see BioCentury, Jan., 10, 2000).

PDUFA fees (January 4, 2000)
FDA's prescription drug user fee rates for fiscal 2000.

TOP