Product documentation (December 23, 2002)
� Bexxar: FDA briefing documents for the Dec. 17, 2002, meeting of the Oncologic Drugs Advisory Committee (ODAC) to review Bexxar tositumomab to treat non-Hodgkin’s lymphoma, from Corixa Corp. (CRXA) (see BioCentury, Dec. 23, 2002).
� Casodex: FDA briefing documents for Dec. 18, 2002, meeting of the Oncologic Drugs Advisory Committee (ODAC) to review Casodex bicalutamide to treat early stage prostate cancer, from AstraZeneca plc (AZN; LSE:AZN) (see BioCentury Extra, Wednesday Dec. 18, 2002).
� FluMist: FDA briefing documents for the Dec. 17, 2002, meeting of the Vaccines and Related Biological Products Advisory Committee to review FluMist influenza vaccine, from MedImmune Inc. (MEDI) (see BioCentury, Dec. 23, 2002).

Reimbursement (December 16, 2002)
� Report by an advisory committee to the Secretary of HHS on "Bringing Common Sense to Health Care Regulation." (PDF file)

Diabetes (December 9, 2002)
� NICE appraisal consultation document on the clinical and cost effectiveness of glitazones to treat Type 2 diabetes.

Prescription drugs (December 9, 2002)
� Michigan’s Best Pharmaceutical Practices Medicaid drug plan.

Product documentation (December 9, 2002)
� Synagis: Dear Doctor letter on the risk of anaphylaxis upon re-exposure to Synagis palivizumab to prevent respiratory syncytial virus (RSV) in high-risk infants, from MedImmune Inc. (MEDI).(PDF file)

Alzheimer’s disease (November 25, 2002)
FDA briefing documents for the Nov. 18, 2002, meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review the role of brain imaging as an outcome measure in Phase III AD trials.

European biotech (November 25, 2002)
European Commission report outlining a European strategy for life sciences and biotechnology (see BioCentury, Nov. 25, 2002).

Myocardial infarction (November 25, 2002)
Royal College of Physicians report on the hospital treatment of myocardial infarction (MI) in the U.K.

Alzheimer’s disease (November 18, 2002)
Briefing documents and draft agenda for the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee meeting on Nov. 18, 2002, to discuss the role of brain imaging as an outcome measure in Phase III trials of candidate drugs for AD.

Pharming (November 18, 2002)
� USDA’s Animal and Plant Health Inspection Service (APHIS) website on agricultural biotechnology.

Acne (November 11, 2002)
FDA briefing documents for the Nov. 4, 2002, meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee to discuss efficacy in clinical trials to treat acne.

Technology transfer (PDF file) (November 11, 2002)
GAO report on federal agency efforts in transferring and reporting new technology (see BioCentury, Nov. 11, 2002).

CBER-CDER reorganization (PDF file) (November 4, 2002)
Transcript of the Oct. 25, 2002, meeting of the CBER Science Board (see BioCentury, Nov. 4, 2002).

Immunotoxicology (PDF file) (November 4, 2002)
FDA guidance on immunotoxicology evaluation of investigational new drugs, excluding biological products.

Diabetes (October 28, 2002)
NICE appraisal consultation document on the use of continuous subcutaneous insulin infusion to treat diabetes.

Generic drugs (PDF files) (October 28, 2002)
� Proposed HHS rule on patent listing requirements and application of 30-month stays on approval of ANDAs (see BioCentury, Oct. 28, 2002).
� FTC study on generic drug market entry prior to patent expiration.

Pediatric populations (October 21, 2002)
� FDA briefing documents for the Oct. 17, 2002 meeting of the pediatric oncology subcommittee of the Oncologic Drugs Advisory Committee on developing cancer drugs for children.

Product documentation (October 21, 2002)
� Gleevec: NICE final appraisal document on the use of Gleevec imatinib to treat chronic myeloid leukemia, from Novartis AG (NVS SWX:NOVN).

Gene therapy (October 14, 2002)
� Briefing documents for the Oct. 10, 2002, meeting of the FDA’s Biological Response Modifiers Advisory Committee on an adverse event in a French SCID gene therapy patient.

Marketing (PDF file) (October 7, 2002)
HHS Office of Inspector General draft guidance for pharmaceutical manufacturers describing proposed restrictions on discounts to physicians.

Product documentation (September 30, 2002)
� Iressa: Briefing documents for the Sept. 24, 2002, meeting of the FDA’s Oncologic Drugs Advisory Committee to review Iressa gefitinib to treat non-small cell lung cancer, from AstraZeneca plc (AZN) (see BioCentury, Sept. 30, 2002).

Drug imports (PDF file) (September 23, 2002)
Final FDA guidance for FDA regulatory field offices on regulatory procedures for imported products.

Osteoporosis (PDF files) (September 23, 2002)
Final agenda and question list for the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee meeting on Sept. 25, 2002, to discuss clinical trials for new osteoporosis treatments.

Thrombolysis (September 23, 2002)
Final NICE appraisal on drugs for early thrombolysis to treat acute myocardial infarction.

Urological cancer (September 23, 2002)
NICE guidance on improving outcomes in urological cancer.

Bioterrorism (September 16, 2002)
FDA’s information page on the Bioterrorism Act of 2002, which includes the agency’s plans for implementing it.

EPO (PDF file) (September 16, 2002)
American Society of Clinical Oncology and American Society of Hematology guidance on the use of epoetin in patients with cancer.

European research (September 16, 2002)
� Agenda for the upcoming October conference on the establishment of European Research Councils, organized by the Danish Research Council (see BioCentury, Sept. 16, 2002). (PDF file)
� European Research Foundation discussion on the debate to establish European Research Councils (ERC).

Intellectual property (September 16, 2002)
Final report of the U.K. Commission on Intellectual Property Rights on the relationship of IP to the developing world (see BioCentury, Sept. 16, 2002).

Schizophrenia (September 16, 2002)
� NICE call for comment on the treatment and management of schizophrenia.

Toxicity (September 16, 2002)
Meeting documents from the Sept. 9, 2002, meeting of the nonclinical studies subcommittee of the FDA’s Advisory Committee for Pharmaceutical Science on the use of serum troponins as biomarkers of drug-induced cardiac toxicity.

Product documentation (September 16, 2002)
� Spiriva: FDA briefing documents for the Sept. 6, 2002, meeting of the Pulmonary-Allergy Drugs Advisory committee on Spiriva tiotropium to treat chronic obstructive pulmonary disease (COPD), from Boehringer Ingelheim Pharmaceuticals Inc.

Acute coronary syndromes (September 9, 2002)
Revised NICE guidance on the use of glycoprotein IIb/IIIa inhibitors to treat acute coronary syndromes.

Breast cancer (September 3, 2002)
Updated NICE guidance on improving outcomes in breast cancer.

Liposome products (PDF file) (August 26, 2002)
Draft FDA guidance on the chemistry, manufacturing and controls, pharmacokinetics, bioavailability and labeling of liposome drug products.

NICE (August 26, 2002)
� NICE final appraisal document on the clinical and cost effectiveness of long acting insulin analogs to treat diabetes.

Transgenic animals (August 26, 2002)
National Academy of Sciences report, "Animal Biotechnology: Science Based Concerns" (see BioCentury Extra, Wednesday Aug. 21, 2002).

Pediatric trials (PDF file) (August 19, 2002)
FDA request for comments on regulations requiring manufacturers to assess the safety and effectiveness on new drugs and biological products in pediatric patients.

Singapore biotech (August 19, 2002)
� BioMed Singapore homepage.

Generics (PDF files) (August 12, 2002)
� S. 812, the "Greater Access to Affordable Pharmaceuticals Act," passed in the U.S. Senate on July 31 (see BioCentury, Aug, 12, 2002).
� S.2677, the proposed "Consumer Access to Prescription Drugs Improvement Act of 2002," which would direct the Institute of Medicine to analyze the feasibility of generic biologics (see BioCentury, Aug, 12, 2002).

Hepatitis (PDF file) (August 12, 2002)
FDA briefing documents for the Aug. 7, 2002, meeting of the Antiviral Drugs Advisory Committee to discuss clinical trial design issues for drugs to treat chronic hepatitis B.

Product documentation (August 12, 2002)
� Adefovir: FDA briefing documents for the Aug. 6, 2002, meeting of the Antiviral Drugs Advisory Committee to review Adefovir dipivoxil to treat chronic hepatitis B, from Gilead Sciences Inc. (GILD) (see BioCentury, Aug. 12, 2002).

Arthritis (August 5, 2002)
� Briefing documents from the July 29-30, 2002, meeting of CDER’s Arthritis Advisory Committee to dicuss clinical trial issues for arthritis and pain management.

Generic drugs (PDF file) (August 5, 2002)
U.S. Federal Trade Commission study, "Generic Drug Discovery Prior to Patent Expiration" (see BioCentury, Tuesday July 30, 2002).

Scandinavian biotech (August 5, 2002)
� Homepage of BIO Sweden.
� Homepage of Karolinska Institutet.
� Homepage for TEKES, the Finnish National Technology Agency.
� Homepage for Sitra, the Finnish National Fund for Research and Development.

Energy & genomics (July 29, 2002)
Links to the Department of Energy’s Genomes to Life program.

R&D spending (July 29, 2002)
National Science Foundation report, "Changes in Federal and Non-Federal Support for Academic R&D Over the Past Three Decades" (see BioCentury, July 29, 2002).

Patient protection (July 22, 2002)
FDA briefing information for the July 17, 2002, meeting of the Drug Safety and Risk Management Advisory Committee on patient information and education efforts.

Product documentation (July 22, 2002)
� Atacand: FDA briefing documents for the July 18, 2002, meeting of the Cardiovascular and Renal Drugs Advisory committee to discuss a proposed claim of comparative efficacy of Atacand candesartan cilexetil from AstraZeneca plc (AZN) to losartan to treat hypertension.
� Vanlev: FDA briefing documents for the July 19, 2002, meeting of the Cardiovascular and Renal Drugs Advisory committee to review Vanlev omapatrilat to treat hypertension, from Bristol-Myers Squibb Co. (BMY).

Bioequivalence (PDF file) (July 15, 2002)
Draft of a revised FDA guidance on bioavailability and bioequivalence studies for orally administered drug products.

Fast track (July 15, 2002)
Quarterly report on CDER actions on Fast Track applications, and the updated list of approved Fast Track products.

Prescription drugs (July 15, 2002)
HHS report on medical innovation and the considerations posed by prescription drug coverage for senior citizens (see BioCentury, July 15, 2002).

Compulsory licensing (July 8, 2002)
Legal document search engine for World Trade Organization agreements, including documents pertaining to paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (specific search words: IP/C/W/351 - African Group; IP/C/W/352 – EU; IP/C/W/354 - United Arab Emirates; IP/C/W/355 - Bolivia, Brazil, Cuba, China, Dominican Republic, Ecuador, India, Indonesia, Pakistan, Peru, Sri Lanka, Thailand and Venezuela; and IP/C/W/358 - U.S. (see BioCentury, July 8, 2002).

Product documentation (July 8, 2002)
� Camptosar: FDA documentation relating to revised warning label for Camptosar irinotecan to treat metastatic colon cancer, from Pharmacia Corp. (PHA).

Medicare prescription drugs (PDF file) (July 1, 2002)
The Medicare Modernization and Prescription Drug Act of 2002 (H.R. 4954), passed by the House of Representatives last week (see BioCentury, July 1, 2002).

Otitis media (PDF file) (July 1, 2002)
Draft FDA guidance on developing antimicrobial therapies to treat acute otitis media, an ear infection.

Product documentation (July 1, 2002)
� Nolvadex: FDA dear doctor letter for new label warning for Nolvadex tamoxifen to treat breast cancer, from AstraZeneca plc. (AZN). (PDF file)

Drug exports (PDF file) (June 24, 2002)
Proposed FDA rule change on the exportation of unapproved investigational new drugs.

Hungarian EU accession (June 24, 2002)
� Website for the Hungarian Regulatory Affairs Society (HURAS) (see BioCentury, June 24, 2002).
� Website for the Pan-European Federation of Regulatory Affairs Societies (PEFRAS).

Thrombolytics (June 24, 2002)
NICE appraisal consultation document on the use of drugs for early thrombolysis in the treatment of acute myocardial infarction.

Product documentation (June 24, 2002)
� Prilosec: FDA briefing documentation for over-the-counter use of Prilosec omeprazole to treat heartburn, acid indigestion and sour stomach (see BioCentury Extra, Friday June 21).

Commercial speech (PDF file) (June 10, 2002)
FDA guidance for industry on the compliance policy guides manual on pharmacy compounding, developed in response to the recent U.S. Supreme Court in Thompson v. Western States Medical Center (see BioCentury, May 6, 2002).

Orphan drugs (PDF file) (June 10, 2002)
FDA’s cumulative listing of orphan drugs and biological products through Dec. 31, 2001.

Human subject protections (June 3, 2002)
Report by the Inspector General of HHS, "Clinical Trial Web Sties: A Promising Tool to Foster Informed Consent."

Patents (June 3, 2002)
Article 69 of the European Patent Convention, pertaining to the consideration of equivalents (see BioCentury, June 3, 2002). (PDF file)

Psoriasis (May 28, 2002)
Proceedings from the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee meetings on March 20 and Oct. 20, 1998, related to clinical endpoints for assessing efficacy of psoriasis treatments (see BioCentury, May 28, 2002).

Product documentation (May 28, 2002)
� Amevive: Briefing documents for the May 23, 2002, meeting of the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee to review Amevive alefacept to treat psoriasis, from Biogen Inc. (BGEN) (see BioCentury, May 28, 2002).

Human subject protections (PDF file) (May 20, 2002)
The Human Research Subject Protections Act of 2002 (H.R. 4697), requiring disclosure of financial interests of investigators to trial participants (see BioCentury Extra, Tuesday May 14).

Information dissemination (May 20, 2002)
� FDA’s request for comment on constitutional issues related to commercial freedom of speech (see BioCentury, May 20, 2002). (PDF file)
� Draft FDA guidelines related to the quality of information disseminated to the public by the agency.

Gene vectors (May 13, 2002)
Briefing documents for the FDA Biological Response Modifiers Advisory Committee May 10 meeting on inadvertent germline transmission of gene vector transfers.

Neuropathy (May 13, 2002)
Briefing documents for the FDA’s Anesthetic and Life Support Drugs Advisory Committee May 15 meeting on issues regarding regulatory review of drugs to treat peripheral neuropathy and neuropathic pain.

Generics (April 29, 2002)
Federal Trade Commission documentation on its determination that Biovail Corp. (BVF; TSE:BVF) had wrongfully attempted to avoid competition from generic drugs (see BioCentury, April 26, 2002 & BioCentury Extra, Tuesday April 23, 2002).

Product documentation (April 29, 2002)
� Lotronex: FDA briefing material for the April 23, 2002, meeting of the Gastrointestinal Drugs Advisory Committee and drug safety and risk management subcommittee for the reintroduction of Lotronex alosetron to treat to treat women with diarrhea-predominant irritable bowel syndrome, from GlaxoSmithKline plc (GSK; LSE:GSK).

Product documentation (April 15, 2002)
� Cozaar: Briefing information for the April 12, 2002, meeting of the Cardiovascular and Renal Drugs Advisory Committee to review of Cozaar losartan potassium to treat type 2 diabetes patients with nephropathy, from Merck & Co. Inc. (MRK).

Safety reports (PDF file) (April 8, 2002)
FDA guidance on data elements for transmission of individual case safety reports.

Institutional review boards (April 1, 2002)
Maryland House Bill 917, relating to transparency of Institutional Review Boards and other human subject protections (See BioCentury April 1, 2002).

Product documentation (March 25, 2002)
� Picovir: FDA briefing information for the March 19, 2002, Anti-Viral Drugs Advisory Committee review of Picovir pleconaril to treat the common cold, from ViroPharma Inc. (VPHM) (see Biocentury, March 25, 2002).

Bioterrorism (PDF files) (March 18, 2002)
� Draft FDA guidance on developing antimicrobiral drugs to treat inhalational anthrax post-exposure.

Clinical trials (PDF file) (March 18, 2002)
� FDA guidance on its information access program for sponsors submitting data to the Clinical Trials Data Bank mandated the by Food and Drug Modernization Act.

NIH data (March 11, 2002)
Draft NIH statement regarding sharing of final research data from NIH-supported studies for use by other researchers, including requirements for investigator applicants to include a plan for data sharing.

Stem cells (March 4, 2002)
� Report from the House of Lords Select Committee on Stem Cell Research (see BioCentury, March 4, 2002).

Stock options (PDF file) (February 25, 2002)
S. 1940, the "Ending the Double Standard for Stock Options Act’’ (see BioCentury, Feb. 25, 2002).

Bioterrorism (February 11, 2002)
� Draft NIH request for proposals for development and testing of vaccines against anthrax. (PDF File)
� HHS website for the Council on Private Sector Initiatives (CPSI) to improve the security, safety, and quality of health care in the post-September 11 environment and for the solicitation of private sector bioterror proposals.

Product documentation (February 11, 2002)
� Caelyx: Initial recommendations by the National Institute for Clinical Excellence (NICE) on the use of Caelyx peglyated liposomal doxorubicin to treat advanced ovarian cancer, from Schering-Plough Corp (SGP). The product, developed by Johnson & Johnson subsidiary Alza Corp., is sold in the U.S. as Doxil.

Conflict of interest (February 4, 2002)
Draft FDA guidance on disclosing conflicts of interest for advisory committee meeting participants (see BioCentury Extra, Wednesday Jan. 30, 2002).

Beta interferon (January 28, 2002)
� NICE press release on the Appeal Panel’s decision.

Cloning (January 22, 2002)
National Academy of Sciences’ report on therapeutic cloning, "Scientific and Medical Aspects of Human Reproductive Cloning."

User fees (PDF file) (January 22, 2002)
FDA notice on the establishment of PDUFA rates for fiscal 2002.

Xenotransplantation (January 22, 2002)
Briefing documentation for the Campaign for Responsible Transplantation’s suit against FDA, claiming violation of the Freedom of Information Act regarding failure to disclose thousands of pages of agency documents on clinical xenotransplant trials.

HIV (January 14, 2002)
Briefing documents for Jan. 11 meeting of the FDA’s Antiretroviral Drugs Advisory Committee on clinical trial design for antiretroviral agents for HIV.

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