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2004 Links Archive
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These links take users to additional information, announcements, and government documents mentioned in BioCentury's publications.

Pharmacovigilance (December 20, 2004)
— A January 2003 summary of an EMEA ad hoc working group on establishing a European risk management strategy (see BioCentury, Dec. 17). (PDF file)
Newly posted files from FDA’s Adverse Events Reporting System (AERS), covering 1Q04.

Product documentation (December 20, 2004)
Celebrex: FDA information page listing alerts, statements and patient information for Celebrex celecoxib, from Pfizer Inc. (PFE) (see BioCentury, Dec. 17).
Procrit: Dear Healthcare Professional letter, posted by FDA this month, concerning changes to safety and dosing information for Procrit epoetin alfa, from Johnson & Johnson (JNJ). (PDF file)

CalPERS records (December 13, 2004)
CalPERS settlement with the California First Amendment Coalition, and records of fees and profits resulting from participation in private equity funds.

Depression (December 13, 2004)
NICE guidances on improving the treatment for depression and anxiety.

Disclosure (December 13, 2004)
Online clinical trial registry for results of all marketed products and initiation of all Phase II - Phase IV trials, from Eli Lilly and Co. (LLY).

Drug ratings (December 13, 2004)
Consumers Union drug rating web site intended to provide comparisons of the price, effectiveness and safety of prescription drugs (see BioCentury Extra, Thursday Dec. 9).

GMO crops (PDF file) (December 13, 2004)
University of Minnesota report summarizing international research and development of genetically modified crops.

HIV (PDF files) (December 6, 2004)
— FDA draft guidance on the role of HIV drugs resistance testing during antiretroviral drug development.

Toxicology (PDF file) (December 6, 2004)
FDA draft guidance on approaches to integrating genetic toxicology assay results during drug development.

Product documentation (December 6, 2004)
— Clolar: Briefing documents for the Dec. 1 meeting of FDA's Oncologic Drugs Advisory Committee to discuss the NDA for Clolar clofarabine to treat refractory or relapsed acute lymphocytic leukemia (ALL) and acute myelogenous leukemia (AML) in pediatric patients, from Ilex Oncology Inc. (ILXO).
— Marqibo: Briefing documents for the Dec. 1 meeting of FDA's Oncologic Drugs Advisory Committee to discuss the NDA for Marqibo vincristine to treat relapsed, aggressive non-Hodgkin's lymphoma (NHL), from Enzon Pharmaceuticals Inc. (ENZN) and Inex Pharmaceuticals Corp. (TSE:IEX).

Cancer drugs (PDF file) (November 22, 2004)
Notice of Dec. 1 meeting of FDA's Oncologic Drugs Advisory Committee (ODAC) to review NDAs for Clolar clofarabine to treat refractory or relapsed acute leukemias, from Ilex Oncology Inc. (ILXO), and Marquibo vincristine to treat third-line non-Hodgkin's lymphoma (NHL), from Inex Pharmaceuticals Corp. (TSE:IEX).

Drug safety (November 22, 2004)
ICH guideline E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions.

GMO safety (PDF file) (November 22, 2004)
FDA draft guidance discussing an approach for assessing the food safety of new proteins produced by bioengineered plant varieties (see BioCentury Extra, Friday Nov. 19).

Human tissue (November 22, 2004)
FDA final regulations (PDF file) for current good tissue practice (cGTP) for the manufacture of human cell, tissue, and cellular- and tissue-based products.

Flu vaccine (November 15, 2004)
HHS pandemic influenza response and preparedness plan.

GM crops (PDF file) (November 15, 2004)
Report from NAFTA’s Commission for Environmental Cooperation that advocates a continued moratorium on commercial planting transgenic corn in Mexico.

Product documentation (PDF files) (November 15, 2004)
Humira: Dear Healthcare Professional letter describing new warnings for drug interactions, hypersensitivity reactions and hematologic events for Humira adalimumab to treat rheumatoid arthritis (RA), from Abbott Laboratories (ABT).

Reimbursement (November 8, 2004)
Centers for Medicare & Medicaid Services (CMS) draft decision to reimburse off-label use of four marketed cancer drugs in trials sponsored by the National Cancer Institute.

Product documentation (November 8, 2004)
— Camptosar: Briefing information for the Nov. 3-4 meeting of the clinical pharmacology subcommittee of FDA's Advisory Committee for Pharmaceutical Science to discuss toxicities associated with advanced colorectal cancer drug Camptosar irinotecan, from Pfizer Inc. (PFE).

Reimportation (PDF file) (November 1, 2004)
Opinion of the Advocate General of the European Court of Justice, in a case brought by Greece against GlaxoSmithKline, regarding the ability of pharma companies to limit sales in some markets in order to restrict parallel trade.

Post-marketing studies (November 1, 2004)
Quarterly updated FDA website on Phase IV commitments.

Product documentation (November 1, 2004)
— Glivec: NICE guidance on use of Glivec (Gleevec) imatinib to treat gastrointestinal stromal tumors (GISTs), from Novartis AG (SWX:NOVN; NVS).

Agricultural biotechnology (October 25, 2004)
USDA database identifying U.S. utility patents on inventions in biotechnology and changes in patent ownership due to mergers, acquisitions and spinoffs.

Critical Path initiative (October 18, 2004)
Slides from CBER's Oct. 7 workshop on FDA's Critical Path initiative on drug development.

Manufacturing (October 18, 2004)
Briefing information for the Oct. 19-20 meeting of FDA's Advisory Committee for Pharmaceutical Science.

Product documentation (October 18, 2004)
— Remicade: FDA "Dear Healthcare Professional" letter on safety information concerning malignancies associated with use of Remicade infliximab to treat rheumatoid arthritis and Crohn's disease, from Johnson & Johnson (JNJ) (see BioCentury Extra, Friday Oct. 15). (PDF file)

Anti-infectives (PDF file) (October 11, 2004)
Briefing documents for the Oct. 16 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss catheter-related bloodstream infections.

Manufacturing (PDF files) (October 11, 2004)
— FDA guidance on the cGMP for sterile drug products produced by aseptic processing.
— FDA guidance on processing analytical technology (PAT) in pharmaceutical development.

Product documentation (October 11, 2004)
—Levoxyl: Dear Healthcare Professional letter about new safety labeling for Levoxyl levothyroxine for thyroid hormone replacement or supplemental therapy for hypothyroidism, from King Pharmaceuticals Inc. (KING). (PDF file)
—Rituxan: Dear Healthcare Professional letter about revisions to the warnings section of the prescribing information due to reports of hepatitis B (HBV) reactivation among some patients given Rituxin rituximab to treat non—Hodgkin's lymphoma, from Genentech Inc. (DNA) and Biogen Idec Inc. (BIIB). (PDF file)

International Conference on Harmonization (October 4, 2004)
FDA announcement of an Oct. 19 public meeting to discuss the ICH process and the Nov. 15-18 meeting of the ICH in Yokohama, Japan. (PDF file)

Manufacturing (October 4, 2004)
Final FDA report on its Pharmaceutical Current Good Manufacturing Practices for the 21st Century initiative. (PDF file)
FDA draft guidance on good manufacturing practice for combination products.
FDA white paper on the role of quality systems in pharmaceutical cGMP regulations. (PDF file)

HIV vaccines (September 27, 2004)
— NIH information for researchers on conducting preclinical toxicology testing and development for HIV vaccines.
Briefing information for September 22-23 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to review an IND for a study in Thailand of an HIV-1 vaccine composed of ALVAC from Sanofi-Aventis S.A. (Euronext:SAN; SNY) boosted by gp120 from VaxGen Inc. (VXGN) (see BioCentury, Jan. 19, 2004).

Serological assays (PDF file) (September 27, 2004)
FDA Class II special controls guidance on the development of serological assays to detect beta-glucans for fungal infections.

Product Documentation (September 27, 2004)
— Menactra: FDA briefing documents for Sept. 22 meeting of FDA's Vaccines and Related Biological Products Advisory Committee to review Menactra meninogococcal polysaccharide diptheria toxoid conjugate vaccine, from Aventis Pasteur Inc.

Antidepressants (September 20, 2004)
— Briefing information for the Sept. 13-14 joint meeting of FDA's Psychopharmacologic Drugs and Pediatric Drugs advisory committees to discuss the use of antidepressants in children.

Anti-infective drugs (PDF file) (September 20, 2004)
Notice of Oct. 14 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss design of clinical studies of bacteremia.

Pharmaceutical science (PDF file) (September 20, 2004)
Notice of Oct. 19-20 meeting of FDA's Advisory Committee for Pharmaceutical Science to discuss the agency's Critical Path initiative and other topics.

Antidepressants (September 13, 2004)
Notice of amended meeting procedure for the Sept. 13-14 joint meeting of FDA's Psychopharmacologic Drugs and Pediatric Drugs advisory committees to discuss the use of antidepressants in children.

Clinical trial registries (PDF file) (September 13, 2004)
Statement of The International Committee of Medical Journal Editors, published in the New England Journal of Medicine, announcing that its 11 member journals will require registration in a public trials registry for clinical efficacy studies beginning after July 1, 2005, as a condition of consideration for publication (see BioCentury Extra, Sept. 8, 2004).

Obesity drugs (September 13, 2004)
Briefing documents for the Sept. 8 meeting of FDA's Endocrinologic and Metabolic Drugs Advisory Committee to discuss a draft guidance on the clinical evaluation of weight-control drugs.

Product Documentation (September 13, 2004)
— Exanta: Briefing documents from the Sept. 10 meeting of FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss an NDA for anticoagulant Exanta ximelagatran, from AstraZeneca plc (LSE:AZN; AZN).

Clinical trial disclosure (September 6, 2004)
Clinical trials registry providing summary results of trials sponsored by GlaxoSmithKline plc (GSK) (see BioCentury Extra, Wednesday, Sept. 1).

Human subject protections (PDF file) (September 6, 2004)
HHS Office of Human Research Protections guidance on when research involving coded private information or biological specimens is research involving human subjects.

Pediatric research (September 6, 2004)
Notice of the Sept. 10 meeting of the pediatric ethics subcommittee of FDA’s Pediatric Advisory Committee to discuss an IRB for a proposed clinical trial involving a single dose of dextroamphetamine for children with attention deficit hyperactivity disorder (ADHD).

Weight-control drugs (September 6, 2004)
Notice of the Sept. 8 meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee to discuss a draft guidance on weight-control drugs.

Product Documentation (September 6, 2004)
Exanta: Notice of Sept. 10 meeting of FDA’s Cardiovascular and Renal Drugs Advisory Committee meeting to discuss the NDA for Exanta ximelagatran to prevent venous throboembolism (VTE), from AstraZeneca plc (AZN).
Geodon: Dear Healthcare Practitioner letter warning of the risk of hyperglycemia and diabetes related to Geodon ziprasidone to treat schizophrenia and acute bipolar mania, from Pfizer Inc. (PFE). (PDF file)

Atopic eczema (August 30, 2004)
NICE guidance on the use of Protopic tacrolimus, from Fujisawa Pharmaceutical Co. Ltd., and Elidel pimecrolimus, from Novartis AG (NVS; SWX:NOVN), and advice on how frequently topical corticosteroids should be applied for atopic eczema.

Dyspepsia (August 30, 2004)
NICE guidance on management of dyspepsia in adults.

Hypertension (August 30, 2004)
NICE guidance on management of hypertension in adults.

Product Documentation (August 30, 2004)
Macugen: FDA briefing documents from the Dermatologic and Ophthalmic Drugs Advisory Committee meeting on Aug. 27 to discuss an NDA for Macugen pegaptanib to treat wet age-related macular degeneration, from Eyetech Pharmaceuticals Inc. (EYET) and Pfizer Inc. (PFE) (see BioCentury, August 30).
Remicade: Dear Healthcare Professional letter warning of hematologic and neurologic events related to Remicade infliximab to treat rheumatoid arthritis and Crohn’s disease, from Johnson & Johnson (JNJ) (PDF file) (see BioCentury, August 30).

Follow-on biologics (PDF file) (August 23, 2004)
FDA announcement of a Sept. 14-15, public workshop on scientific considerations related to developing follow-on protein products. FDA is seeking comments on manufacturing issues, characterization of protein products, immunogenecity, preclinical and clinical development, and terminology.

Reimportation (August 23, 2004)
Complaint (PDF file) by the State of Vermont against FDA, seeking a declaratory judgment to authorize the importation of prescription drugs from Canada, and a response from FDA (see BioCentury Extra, Friday Aug. 20).

Product documentation (PDF files) (August 16, 2004)
— Avastin: Dear Healthcare Provider letter warning of an increased risk of serious arterial thromboembolic events related to the use of Avastin bevacizumb to treat colorectal cancer, from Genentech Inc. (DNA).

User fee rates (PDF file) (August 9, 2004)
FDA announcement of the rates for prescription drug user fees for 2005.

PDUFA (PDF file) (August 2, 2004)
FDA's PDUFA user fee rates for fiscal 2005.

Product documentation (August 2, 2004)
— Alimta: Briefing documents for the July 27 meeting of FDA's Oncology Drugs Advisory Committee to review Alimta pemetrexed to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) refractory to chemotherapy, from Eli Lilly and Co. (LLY).

Animal drugs (PDF file) (July 26, 2004)
The Minor Use and Minor Species Animal Health Act of 2003 (S. 741), passed by the U.S. Senate to provide incentives for developing drugs for animals (see BioCentury Extra, Wednesday July 21).

Bioshield (PDF file) (July 26, 2004)
The Project Bioshield Act of 2004, as signed into law by President Bush (see BioCentury Extra, Wednesday July 21).

Guidance documents (PDF file) (July 26, 2004)
FDA announcement of the withdrawal of six clinical guidances because they are out of date.

Product documentation (July 26, 2004)
Alimta: Briefing documents for the July 27 meeting of FDA’s Oncologic Drugs Advisory Committee to discuss the NDA for Alimta pemetrexed to treat malignant pleural mesothelioma and non-small cell lung cancer (NSCLC), from Eli Lilly and Co. (LLY).

Pharmacogenomic products (PDF file) (July 19, 2004)
Notice of July 29 meeting of FDA and the Drug Information Association on pharmacogenomic combination products.

Product documentation (July 19, 2004)
— GEM 21S: FDA briefing documents from the July 13 meeting of the Medical Devices Advisory Committee of the Dental Products Panel to review GEM 21S to treat bone defects of the jaw in patients with advanced periodontal disease, as well as other cranio-maxillofacial (CMF) indications, from BioMimetic Pharmaceuticals Inc. (see BioCentury Extra, Wednesday July 14).
— Tazoral: FDA briefing documents from the July 12 meeting of the Dermatologic & Ophthalmic Drugs Advisory Committee to review Tazoral oral tazarotene to treat moderate to severe psoriasis, from Allergan Inc. (AGN) (see BioCentury Extra, Tuesday July 13).
— Zelnorm: FDA briefing documents for the July 14 meeting of the Gastrointestinal Drugs Advisory Committee to review an sNDA for Zelnorm tegaserod to treat chronic constipation, from Novartis AG (NVS; SWX:NOVN).

Product documentation (July 12, 2004)
— Zelnorm: Notice of July 14 meeting of FDA's Gastrointestinal Drugs Advisory Committee to review an NDA for Zelnorm tegaserod to treat patients with chronic constipation and relief of associated symptoms of straining, hard or lumpy stools, and infrequent defecation, from Novartis AG (NVS; SWX:NOVN).

Product documentation (July 5, 2004)
Effexor: Dear Doctor letter warning of clinical worsening and suicide risk associated with Effexor venlafaxine to treat depression, from Wyeth (WYE). (PDF file)

Mode of action (PDF file) (June 28, 2004)
FDA notice of extension of the comment period for a proposed rule to define the primary mode of action of combination drug products.

Product documentation (June 28, 2004)
— Alimta: Notice of July 27 meeting of FDA's Oncologic Drugs Advisory committee to review the NDA for Alimta pemetrexed to treat locally advanced or metastatic non-small cell lung cancer, from Eli Lilly and Co. (LLY). (PDF file)

EBE (June 21, 2004)
Website of the European trade organization Emerging Biotechnology Enterprises (see BioCentury, June 21).

Pediatric studies (PDF file) (June 21, 2004)
FDA notice of availability of summaries of medical and clinical pharmacology reviews of pediatric studies.

Pulmonary-Allergy drugs (June 21, 2004)
Documents from the May 10 meeting of FDA’s Pulmonary-Allergy Drugs Advisory Committee on the use of ozone-depleting substances in drug products.

Botanical products (PDF file) (June 14, 2004)
FDA guidance explaining when a botanical drug may be marketed under an OTC monograph and when an NDA is required, and advising on the submission of INDs for botanical drug products.

Gout (June 14, 2004)
Slides presented at the June 2 meeting of FDA's Arthritis Drugs Advisory Committee to discuss clinical trial design and endpoints for drugs to treat gout.

International Conference on Harmonisation (PDF file) (June 14, 2004)
Guidance on how to use stability data generated in accordance with ICH guidance Q1A9(R2) Stability Testing of New Drug Substances and Products.

Gout (June 7, 2004)
Documents for the the June 2 meeting of FDA's Arthritis Drugs Advisory Committee to discuss an NDA for Oxypurinol capsules from Cardiome Pharma Corp. (TSE:COM; COMRF) and clinical trial design and endpoints for drugs to treat gout

Pediatric drugs (June 7, 2004)
Notice of June 9 meeting of FDA's pediatric subcommittee of the Anti-Infective Drugs Advisory Committee to discuss adverse event reporting as mandated by the Best Pharmaceuticals for Children Act.

Reimportation (PDF file) (June 7, 2004)
Proposed FDA rule revision concerning type of notification and record-keeping for exported products.

Orphan drugs (PDF files) (May 31, 2004)
FDA cumulative list of Orphan Drugs and orphan designations as of Dec. 31, 2003.

PMA submissions (PDF file) (May 31, 2004)
FDA guidance for industry on user fees and refunds for 510(k) premarket notification submissions.

Tracking survey (PDF file) (May 31, 2004)
FDA notice on proposed national tracking survey of prescription drug information.

Agbiotech (May 24, 2004)
Federal and state legislative activity in 2003 related to agricultural biotechnology.

510(k) submissions (PDF file) (May 24, 2004)
FDA guidance on how certain regulatory events affect the review clock and assessment.

HIV/AIDS (PDF file) (May 24, 2004)
FDA draft guidance on an expedited review process for approving fixed-dose combinations of approved HIV drugs (see BioCentury Extra, Monday, May 17, 2004).

Innovation (PDF file) (May 24, 2004)
HHS announcement seeking public comment on how agencies can work together to stimulate innovation in medical technologies.

Product documentation (May 24, 2004)
Glivec: NICE appraisal consultation document for Glivec (Gleevec) imatinib to treat unrespectable an/or metastatic gastrointestinal stromal tumors, from Novartis AG (NVS; SWX:NOVN).

EU Networks of Excellence (May 17, 2004)
— Descriptions of projects under the European Vascular Genomics Network.

Product documentation (May 17, 2004)
Desyrel: Dear Doctor letter for Desyrel trazodone for depression from Bristol-Myers Squibb Co. (BMY), warning of label revisions citing potential drug interactions when given with CYP3A4 inhibitors ketoconazole, ritonavir, and idinavir. (PDF file)

Conflict of interest (PDF file) (May 10, 2004)
NIH Blue Ribbon Panel draft report on conflict of interest in research.

Osteoporosis (May 10, 2004)
NICE appraisal consultation document for compounds for the secondary prevention of osteoporotic fractures in postmenopausal women.

Product documentation (May 10, 2004)
— Oxandrin: Dear Doctor letter for Oxandrin oxandrolone from Savient Pharmaceuticals Inc. (SVNT), regarding concurrent dosing with the anticoagulant warfarin. Oxandrin is indicated to treat involuntary weight loss.
— Tequin: Notice of May 10 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss NDA for oral suspension of Tequin gatifloxacin to treat recurrent bacterial otitis media and failures of acute bacterial otitis media in pediatric patients, from Bristol-Myers Squibb Co. (BMY). (PDF file)

Product Documentation (May 3, 2004)
Genasense: Briefing documents for the May 3-4 meeting of FDA’s Oncologic Drugs Advisory Committee (ODAC) to discuss the NDA for Genasense oblimersen sodium to treat advanced malignant melanoma, from Genta (GNTA).
RSR13: Briefing documents for the May 3-4 meeting of FDA’s ODAC to discuss the NDA for RSR13 efaproxiral to treat brain metastases originating from breast cancer, from Allos Therapeutics Inc. (ALTH).

Patents (April 26, 2004)
National Academy of Sciences report, "A Patent System for the 21st Century".

SEC (April 26, 2004)
Guidance regarding the Management's Discussion & Analysis of Financial Condition and Results of Operations (MD&A) sections of SEC filings.

FDA communications (PDF file) (April 19, 2004)
Notice of a May 11-13 meeting on improving FDA-industry communications throughout the drug development process.

Foot infections (April 19, 2004)
Briefing documents for the May 6-7 joint meeting of the Nonprescription Drugs Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee to discuss trial design and product labeling for tinea pedis and dermatophyte infections.

Price controls (April 12, 2004) (April 12, 2004)
The state website for pharmacy benefits for Medicaid fee-for-service, State Medical Program, and Children’s Special Health Care Services fee-for-service (see BioCentury, April 12).

CBER (April 5, 2004)
— Presentations from CBER 101: Introduction to the Center for Biologics Evaluation and Research, held March 22-24, 2004.

Gene transfer (April 5, 2004)
Website for FDA and NIH's GeMCRIS human gene transfer research data system.

Gene therapy (March 29, 2004)
— Announcement from NIH and FDA of the Genetic Modification Clinical Research Information System (GeMCRIS) - a web-accessible database on human gene transfer.

Factor V Leiden (DOC file) (March 22, 2004)
FDA Class II special controls guidance on Factor V Leiden DNA mutation detection systems.

Manufacturing (March 22, 2004)
FDA guidance outlining a new compliance policy for pharmaceutical manufacturing processes (see BioCentury Extra, Thursday March 18).

Regulatory science (PDF file) (March 22, 2004)
FDA white paper, “Innovation or Stagnation? Challenge and Opportunity on the Critical Path to New Medical Products” (see BioCentury, March 22).

Reimportation (March 22, 2004)
List of members of the newly formed HHS Task Force on Drug Reimportation (see BioCentury Extra, Tuesday, March 16).

Product documentation (March 22, 2004)
Xigris: NICE appraisal consultation document on Xigris drotrecogin alfa to treat severe sepsis, from Eli Lilly and Co. (LLY).

Cardiovascular disease (PDF file) (March 15, 2004)
Notice of a March 18-19 meeting of FDA's Biological Response Modifiers Advisory Committee to discuss early phase clinical trials of cellular therapies for the treatment of cardiac diseases.

Pediatric drugs (PDF files) (March 15, 2004)
Notice of March 17 meeting of FDA's oncology subcommittee of the Oncologic Drugs Advisory Committee (ODAC) to discuss safety monitoring of cancer studies involving children and the use of supplemental nonclinical data to evaluate cancer therapies.

SEC rules (March 15, 2004)
Securities and Exchange Commission's proposed amendments to adopt additional reporting requirements for filing a Form 8-K.

Generics (March 8, 2004)
— FDA request for comments on regulatory actions needed to approve ANDAs. (PDF file)

Reimports (PDF file) (March 8, 2004)
S. 2137, The Pharmaceutical Market Access Act of 2003, authorizing the Secretary of HHS to promulgate regulations for the reimportation of prescription drugs.

Atopic eczema (March 1, 2004)
NICE appraisal consultation document on the frequency of application of topical corticosteroids for atopic eczema.

Counterfeit drugs (February 23, 2004)
Final report from FDA's Counterfeit Drug Task Force to identify ways to combat counterfeit prescription drugs in the U.S.

Reimbursement (PDF file) (February 23, 2004)
The U.S. Court of Appeals for the District of Columbia Circuit decision in a lawsuit filed by Amgen Inc. against the Center for Medicare & Medicaid Services (CMS) regarding reimbursement for Aranesp darbepoetin alfa (see Ax).

Product documentation (February 23, 2004)
— Accutane: Briefing documents for the Feb. 26-27 joint meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee to discuss the risk management program for the prevention of fetal exposure to Accutane isotretinoin, an anti-acne drug from Roche (SWX:ROCZ).

Estrogen products (February 16, 2004)
— FDA draft guidance on labeling of noncontraceptive estrogen products to treat vasomotor symptoms and vulvar and vaginal atrophy symptoms. (PDF file)

CBER (February 9, 2004)
Updated organizational overview for CBER.

TSE (February 9, 2004)
Briefing documents for the Feb. 12-13 meeting of FDA’s Transmissible Spongiform Encephalopathies Advisory Committee to discuss minimizing the risk of TSE agents in medicinal products. (1) (2)

Clinical trials (PDF file) (February 2, 2004)
Draft FDA guidance on submitting information to the Clinical Trials Data Bank for serious or life-threatening diseases.

Pediatrics (February 2, 2004)
Briefing information for the Feb. 2 meeting of FDA's Psychopharmacologic Drugs Advisory Committee and the Anti-Infective Drugs Advisory Committee to discuss use of antidepressants in children.
— Briefing information for the Feb. 3-4 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss the use of imaging drugs to diagnose and manage cardiac disease in children.

Biodefense (January 26, 2004)
Memorandum of understanding between FDA and EPA on collaborative R&D and emergency response efforts for homeland security. (PDF file)

Drug approvals (January 26, 2004)
— Eight FDA new drug approval reports are listed in CDER's "Whats New" page for Jan. 21.

CMC submissions (PDF file) (January 12, 2004)
FDA draft guidance on the chemistry, manufacturing and controls (CMC) information for drug substances that should be submitted to support NDAs and ANDAs.

Durus, Esperion (January 12, 2004)
13D filing by Durus Capital Management to the SEC on July, 29, 2003, documenting its trading activity in Esperion Therapeutics Inc. (ESPR) (see BioCentury, Jan. 12).

PDUFA performance (January 12, 2004)
FDA performance on Fast Track designation requests.

Antipsychotics (PDF file) (January 5, 2004)
FDA draft guidance on designing bioequivalence studies for generic clozapine products.

FDA advisory committees (PDF file) (January 5, 2004)
Tentative schedule of FDA advisory committee meetings for 2004.

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