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2003 Links Archive
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These links take users to additional information, announcements, and government documents mentioned in BioCentury's publications.

Biogenerics (PDF files) (December 22, 2003)
Amendments to the EU's pharmaceutical legislation adopted by the Parliament on Dec. 17, 2003 (see BioCentury, Dec. 22).

Osteoporosis (December 22, 2003)
NICE appraisal consultation document for technologies to prevent and treat osteoporosis and to prevent osteoporotic fractures in postmenopausal women.

Post-marketing (PDF file) (December 22, 2003)
Request for comments on FDA guidance, "Changes to an Approved New Drug Application or Abbreviated New Drug Application."

Reproductive health
Contraceptives
(December 22, 2003)
FDA briefing documents for the Dec. 15 meeting of the Advisory Committee for Reproductive Health Drugs to discuss the safety and potential clinical benefit of combining folic acid and an oral contraceptive in a single product.

Product documentation (December 22, 2003)
— Plan B: FDA briefing information from the Dec. 16 meeting of the Nonprescription Drugs Advisory Committee and the Advisory Committee for Reproductive Health Drugs to consider the safety and efficacy of over-the-counter use of Plan B levonorgestrel from Women's Capital Corp. for reducing the chance of pregnancy after unprotected sex.

Electronic regulatory submissions (December 15, 2003)
Final FDA rule requiring NDA and certain BLA sponsors to submit in electronic format the content of the package insert or professional labeling.

Patent legislation (PDF file) (December 15, 2003)
H.R. 1561, in the U.S. House of Representatives, on user fees for patent applications (see BioCentury, Dec. 15).

Product documentation (December 15, 2003)
— Ranexa: Briefing documents from the Dec. 9 meeting of the FDA's Cardiovascular and Renal Drugs Advisory Committee to review Ranexa ranolizine to treat chronic angina, from CV Therapeutics Inc. (CVTX) (see BioCentury, Dec. 15).

Aspirin (December 8, 2003)
Briefing documents for the Dec. 8 meeting of FDA’s Cardiovascular and Renal Drugs Advisory Committee to discuss whether aspirin should be recommended for primary prevention of myocardial infarction.

Cancer (December 8, 2003)
Briefing documents for the Dec. 16 meeting of the Oncologic Drugs Advisory Committee to discuss general issues on endpoints for cancer drugs, and for lung cancer in particular.

Drug screening (DOC file) (December 8, 2003)
FDA draft guidance on premarket submission and labeling recommendations for assays intended to screen for drugs of abuse.

Glaxo (PDF file) (December 8, 2003)
Product pipeline update from GlaxoSmithKline plc (LSE:GSK; GSK) (see BioCentury, Dec. 8).

Pediatric drugs (PDF file) (December 8, 2003)
The Pediatric Research Equity Act of 2003 as passed by the U.S. Senate.

Sound-alike names (December 8, 2003)
Briefing documents for the Dec. 4 meeting of the Drug Safety and Risk Management Advisory Committee to discuss reducing errors resulting from look-alike and sound-alike names.

Product documentation (December 8, 2003)
Arava: Updated prescribing information for Arava leflunomide to treat rheumatoid arthritis (RA), from Aventis S.A. (AVE). (PDF file)
Cialis: FDA approval documents for Cialis tadalafil to treat erectile dysfunction (ED), from Icos Corp. (ICOS) and Eli Lilly and Co. (LLY).
Plenaxis: FDA approval documents for Plenaxis abarelix and the PLUS risk-management program from Praecis Pharmaceuticals Inc. (PRCS).

Medicare (PDF files) (November 24, 2003)
Summary of the House-Senate conference agreement on Medicare.

Regional development (November 24, 2003)
"BioScience 2015,” a report on the future of U.K. biotech by the Bioscience Innovation and Growth Team (see BioCentury, Nov. 24).

Product documentation (November 24, 2003)
Taxus: Briefing documents from the Nov. 20, 2003, Circulatory System Devices Panel meeting to review the Taxus paxclitaxel-eluting stent from Boston Scientific Corp. (BSX) and Angiotech Pharmaceuticals Inc. (TSE:ANP; ANPI) (see BioCentury, Nov. 24, 2003).

Cancer (November 17, 2003)
Announcement by the joint FDA and NCI Interagency Oncology Task Force on new initiatives to improve development of cancer therapeutics.
Link to the Interagency Oncology Task Force system for submitting INDs electronically under the Cancer Biomedical Informatics Grid (caBIG) project.

Pharmacogenetics (November 17, 2003)
Briefing documents for the Nov. 17-18 meeting of the clinical pharmacology subcommittee of the FDA's Advisory Committee for Pharmaceutical Science to discuss quantitative analysis using exposure-response, pediatric bridging, drug interactions and pharmacogenetics.

Human subject protections (PDF file) (November 10, 2003)
FDA guidance on authorizations provided to research subjects prior to enrolling in clinical investigations.

Modular PMAs (November 10, 2003)
FDA guidance on procedures for submitting or reviewing a modular pre-market approval application.

Conflict of interest (PDF file) (November 3, 2003)
Proposals by the U.K. Financial Services Authority (FAS) to limit analyst conflict of interest (see BioCentury, Nov. 3, 2003)

Generics (PDF file) (November 3, 2003)
Changes and updates to FDA guidances concerning generic drugs.

Product recalls (PDF file) (November 3, 2003)
FDA guidance on product recalls, including removals and corrections.

West Nile virus (PDF file) (November 3, 2003)
FDA guidance regarding Class II special controls on serological reagents for the laboratory diagnosis of West Nile virus.

Product documentation (November 3, 2003)
Cypher: FDA Talk Paper advising physicians of adverse events associated with Cypher coronary stents from Johnson & Johnson (JNJ, New Brunswick, N.J.) (see BioCentury, Nov. 3, 2003).

Acute sinusitis (October 27, 2003)
Briefing documents for the Oct. 28-29 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss clinical trial design in acute bacterial sinusitis.

Atopic dermatitis (October 27, 2003)
Briefing documents for the Oct. 29-30 meeting of FDA's Anti-Infective Drugs Advisory Committee pediatric subcommittee to consider the risks associated with two classes of drugs approved to treat atopic dermatitis (AD) and similar conditions in pediatric patients.

Diabetic foot infection (October 27, 2003)
Briefing documents for the Oct. 28 meeting of FDA's Anti-Infective Drugs Advisory Committee to discuss the design of clinical trials for diabetic foot infections (DFIs).

FDA performance review (October 27, 2003)
FDA request for comment (PDF file) that will lead to a request for proposal for a contractor to evaluate FDA's conduct of first cycle reviews of NDAs, BLAs and efficacy supplements (see BioCentury, June 30 & Oct. 30).

Unapproved drugs (PDF file) (October 27, 2003)
FDA draft guidance on its plan to ensure safety and efficacy of certain unapproved but widely marketed drugs.

Electronic regulatory submissions (PDF file) (October 20, 2003)
Notice that FDA has re-opened the comment period for its draft guidance on providing regulatory submissions in electronic format.

Medicare (PDF file) (October 20, 2003)
The Medicare Prescription Drug Price Negotiation Act (HR 3299) introduced into the House by Rep. John Larson (D-Conn.) (see BioCentury Extra, Thursday Oct. 16).

Manufacturing (October 20, 2003)
Briefing documents for the Oct. 21-22, 2003, meeting of the Advisory Committee for Pharmaceutical Science.

University of California (PDF file) (October 20, 2003)
The University of California’s court-ordered reporting of its investments in private equity funds, and their performance (see BioCentury, Oct. 20, 2003).

Regulatory review (PDF files) (October 13, 2003)
— FDA guidance on the effect on the agency actions on the review clock and performance assessment for premarket approval applications (PMAs).

Patents (October 13, 2003)
The U.S. Patent and Trademark Office initiative to improve the review of biotechnology, pharmaceutical and organic chemistry patent applications that claim more than one invention (see BioCentury Extra, October 6, 2003).

Product documentation (October 13, 2003)
— Prempro/Premphase: Briefing documents for the Oct. 7, 2003, meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to discuss implications for postmenopausal hormone therapy with estrogen/progestin for the prevention and treatment of psteoporosis, from Wyeth (WYE).

Fertility (October 6, 2003)
FDA briefing documents for the Sept. 29, 2003, meeting of the Advisory Committee for Reproductive Health Drugs on study design and outcome measures for clinical trials in induction of ovulation and pregnancy in anovulatory, infertile women, and development of multiple follicles and pregnancy in ovulatory women in assisted reproductive technology (ART) programs.

Hormone therapy and osteoporosis (October 6, 2003)
Briefing documents for the Oct. 7, 2003, meeting of the FDA's Endocrinologic and Metabolic Drugs Advisory Committee on the Women's Health Initiative and implications for postmenopausal hormone therapy with estrogen/progestin in women to prevent and treat osteoporosis.

Lupus (PDF file) (October 6, 2003)
FDA briefing documents for the Sept. 29-30, 2003, meeting of the Arthritis Advisory Committee to develop a concept paper for creating a guidance for the development of drugs, biologics, and devices to treat systemic lupus erythematosis (SLE).

Pediatric cancer drugs (October 6, 2003)
Briefing documents for the Oct. 9, 2003, meeting of FDA's Oncologic Drugs Advisory Committee pediatric subcommittee to discuss cancer drugs for children and cancer pharmacology in infants and young children.

Reimports (October 6, 2003)
— FDA Counterfeit Drug Task Force interim report listing potential options to combat counterfeit drugs. (PDF file)

Product documentation (October 6, 2003)
— Luveris: FDA briefing documents for the Sept. 30, 2003, meeting of the Advisory Committee for Reproductive Health Drugs to review Luveris lutropin alfa from Serono S.A. (SWX:SEO; SRA), combined with recombinant human follicle stimulating hormone (r-hFSH), for induction of ovulation in infertile women.

Advertising (PDF file) (September 29, 2003)
Fair Balance Prescription Drug Advertisement Act of 2003 (H.R. 3155) introduced by Rep. Pete Stark (D-Calif.) (see BioCentury Extra, Tuesday Sept. 23, 2003).

Myopia (PDF file) (September 29, 2003)
Briefing documents for the Sept. 25, 2003, meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee on study design in clinical trials for myopia.

Product documentation (September 29, 2003)
Memantine: FDA briefing documents for the Sept. 24, 2003, meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review an Memantine to treat moderate to severe AD, from Forest Laboratories Inc. (FRX) (see BioCentury, Sept. 29, 2003).
Provigil: FDA briefing documents for the Sept. 25, 2003, meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to review an sNDA for Provigil modafinil to improve wakefulness in patients with excessive sleepiness associated with disorders of sleep and wakefulness, from Cephalon Inc. (CEPH) (see BioCentury, Sept. 29, 2003).

Drug names (September 22, 2003)
Briefing documents for the Sept. 19, 2003 meeting of the Drug Safety and Risk Management Advisory Committee on screening methods to assess sound alike and look alike proprietary drug names.

FP6 funding (September 22, 2003)
Selected presentations of the EBE Emerging Biopharmaceutical Enterprises workshop on 6th Framework Program (see BioCentury, Sept. 22, 2003).

Safety (PDF file) (September 22, 2003)
ICH draft guidance on post-approval safety data management: Standards for expedited reporting.

Fast track (PDF file) (September 15, 2003)
FDA notice of intention to develop a guidance on "Continuous Marketing Applications: Pilot 2 - Scientific Feedback and Interactions During Development of Fast Track Products Under the Prescription Drug User Fee Act."

Product Documentation (September 15, 2003)
— Metvix: Briefing documents for the Sept. 10, 2003, meeting of FDA's Dermatologic and Ophthalmic Drugs Advisory Committee to review Metvix photodynamic therapy to treat basal cell carcinoma (BCC), from PhotoCure ASA (OSE:PHO) (see BioCentury, Sept. 15, 2003).
— Raptiva: Briefing documents for the Sept. 9, 2003, meeting of FDA's Dermatologic and Ophthalmic Drugs Advisory Committee to review Raptiva efalizumab to treat psoriasis, from Genentech Inc. (DNA) and Xoma Ltd. (XOMA) (see BioCentury, Sept. 15, 2003).
— Visudyne: Briefing documents for the Sept. 9, 2003, meeting of the Medicare Coverage Advisory Committee (MCAC) to review the use of Visudyne verteporfin to treat occult choroidal neovascularization (CNV) due to age-related macular degeneration (AMD), from QLT Inc. (TSE:QLT; QLTI, Vancouver, B.C.) (see BioCentury, Sept. 15, 2003).

Drug pricing (September 8, 2003)
Health care reform proposals of VFA, the German Association of Research-Based Pharmaceutical Companies (see BioCentury, Sept. 8, 2003).

Manufacturing (September 8, 2003)
FDA’s “Pharmaceutical cGMPS for the 21st Century — A Risk-Based Approach” (see BioCentury Extra, Wednesday Sept. 3, 2003).

UK biotech (PDF file) (September 8, 2003)
The 12th report on the UK biotechnology industry by the House of Commons Trade and Industry Committee (see BioCentury, Sept. 8, 2003).

Product documentation (September 8, 2003)
Ariflo: Briefing documents for the Sept. 5, 2003, meeting of FDA’s Pulmonary-Allergy Drugs Advisory Committee to review Ariflo cilomilast to treat chronic obstructive pulmonary disease (COPD), from GlaxoSmithKline plc (LSE:GSK, GSK) (see BioCentury, Sept. 8, 2003).

HIV (August 25, 2003)
Briefing documents and questions for the Aug. 20, 2003, meeting of FDA’s Antiviral Drugs Advisory Committee on developing topical microbicides against HIV.

Cell therapy (PDF file) (August 18, 2003)
FDA draft guidance for chemistry, manufacturing, and control (CMC) reviews of INDs for human somatic cell therapies.

Reimbursement (PDF files) (August 18, 2003)
— House bill H.R. 2700, the Medicare Patient Access to Drugs for Rare Diseases Act of 2003.

Product documentation (August 18, 2003)
— Rebetol: NICE appraisal consultation document on the use of pegylated and non-pegylated interferon alpha in combination with Rebetol ribavirin from Schering-Plough Corp. (SGP).

Generics (PDF file) (August 4, 2003)
FDA guidance on 180-day exclusivity when multiple ANDAs are submitted on the same day.

PDUFA (July 28, 2003)
Draft FDA guidance on good review management principles for Prescription Drug User Fee Act products (see BioCentury Extra, Friday July 25, 2003). (PDF file)

Pediatric trials (July 28, 2003)
S. 650, The Pediatric Research Equity Act, passed by the Senate giving FDA the authority to require sponsors to conduct pediatric trials of experimental compounds (see BioCentury Extra, Thursday July 24, 2003). (PDF file)

Counterfeiting (July 21, 2003)
FDA initiative against counterfeit drugs.

Clinical microarrays (July 14, 2003)
— Centers for Medicare and Medicaid Services clinical laboratory improvement amendments (CLIA).

Technology transfer (PDF file) (July 14, 2003)
GAO report on the rights of government agencies to federally sponsored biomedical inventions.

Product documentation (July 14, 2003)
— Crestor: FDA briefing documents for the July 9, 2003 meeting of the Endocrinologic and Metabolic Drugs Advisory committee to review Crestor rosuvastatin to treat hypercholesterolemia, from AstraZeneca plc (AZN; LSE:AZN) (see BioCentury Extra, Wednesday July 9, 2003).

Epilepsy (June 30, 2003)
NICE appraisal consultation documents on newer drugs to treat epilepsy in children and adults.

Product documentation (June 30, 2003)
— Enbrel: FDA briefing documents from the June 24, 2003 Arthritis Advisory Committee meeting on Enbrel etanercept to treat ankylosing spondylitis, from Amgen Inc. (AMGN) (see BioCentury Extra, Tuesday June 24, 2003).
— Photofrin: FDA briefing documents from the June 26, 2003 Gastrointestinal Advisory Committee meeting for Photofrin porfirmer photodynamic therapy to treat high grade dysplasia associated with Barrett's esophagus, from Axcan Pharma Inc. (TSE:AXP; AXCA) (see BioCentury Extra, Friday June 27, 2003).
— Serostim: FDA briefing documents from the June 25, 2003 Gastrointestinal Advisory Committee meeting for Serostim somatropin to treat short bowel syndrome, from Serono S.A. (SWX:SEO; SRA) (see BioCentury Extra, Wednesday June 25, 2003).

FDA product approvals (June 16, 2003)
NDA and NME approvals through May 2003.

Medicare prescription drugs (PDF files) (June 16, 2003)
Senate Bill 1, The Prescription Drug and Medicare Improvements Act of 2003, as passed out of the Finance Committee, and the proposed House legislation: the Medicare Prescription Drug and Modernization Act of 2003 (see BioCentury, June 16, 2003).

Product documentation (June 16, 2003)
Gleevec: NICE appraisal consultation document recommending Gleevec imatinib as first-line treatment in patients with Philadelphia-chromosome-positive chronic myeloid leukaemia (CML) in the chronic phase, from Novartis AG (NVS; SWX:NOVN).

Medical Research Council (PDF files) (June 9, 2003)
House of Commons assessment of the MRC's performance by the U.K.'s Department of Trade and Industries (see BioCentury, June 6, 2003).

Pediatric expertise (June 9, 2003)
FDA guidance on pediatric expertise for advisory panels for premarket approval or 501k applications for devices.

Technology transfer (PDF file) (June 9, 2003)
GAO report analyzing the relationship between NIH and Bristol-Myers Squibb Co. (BMY) in the development of Taxol paclitaxel to treat cancer (see BioCentury Extra, Friday June 3, 2003).

Colorectal cancer (June 2, 2003)
NICE appraisal documents on the use of capecitabine or tegafur with uracil to treat advanced colorectal cancer.

QT prolongation (June 2, 2003)
Briefing documents for the May 29, 2003, meeting of FDA’s Cardiovascular and Renal Drugs Advisory Committee to review QT prolongation in general, and in relation to erectile dysfunction drug Levitra vardenafil, from Bayer AG (FSE:BAYG; BAY) and GlaxoSmithKline plc (LSE:GSK;GSK), and benign prostatic hyperplasia drug UroXatral, from Sanofi-Synthelabo S.A. (Euronext:SNYNF; SNY) (see BioCentury, June 2, 2003).

Clinical development (PDF file) (May 26, 2003)
FDA guidance on the chemistry, manufacturing and controls information for filing INDs for Phase II and Phase III development.

Product documentation (May 26, 2003)
— MabThera (Rituxan): NICE appraisal consultation document on the use of MabThera rituximab to treat aggressive non-Hodgkin’s lymphoma (NHL), from Idec Pharmaceuticals Inc. (IDPH) and Roche (SWX:ROCX) (see BioCentury Extra, Friday May 23, 2003).

Influenza vaccines (May 19, 2003)
NICE appraisal consultation document on the use of Tamiflu oseltamivir from Gilead Sciences Inc. (GILD) and Roche (SWX:ROCZ), and amantadine to prevent influenza.

Mass spectrometry (DOC file) (May 19, 2003)
FDA guidance on the use of mass spectrometry to identify animal drug residues.

Product documentation (May 19, 2003)
Reyataz: FDA briefing documents for the May 13, 2003 Antiviral Drugs Advisory Committee review of an NDA for Reyataz atazanavir to treat HIV, from Bristol-Myers Squibb Co. (BMY).
Xolair: FDA briefing documents for the May 15, 2003 Pulmonary-Allergy Drugs Advisory Committee review of Xolair omalizumab to treat allergic asthma, from Genentech Inc. (DNA), Novartis AG (NVS; SWX:NOVN) and Tanox Inc. (TNOX)

CBER (May 12, 2003)
Slide presentations from a March 24-26, 2003 workshop, "CBER 101 – An Introduction to the Center for Biologics Evaluation and Research."

Clinical trials (PDF file) (May 12, 2003)
Draft FDA guidance on the use of independent consultants for biotechnology clinical trial protocols (see BioCentury Extra, Tuesday May 6, 2003).

Clinical trials (PDF file) (April 21, 2003)
FDA request for comments on procedures for requesting removal of clinical holds.

Product documentation (April 21, 2003)
Kineret: NICE initial appraisal of the use of Kineret anakinra to treat rheumatoid arthritis, from Amgen Inc. (AMGN).

Bipolar disorder (April 14, 2003)
NICE appraisal consulation document on the use of Zyprexa olanzapine, from Eli Lilly and Co. (LLY), and valproate to treat acute mania associated with bipolar disorder.

Embryo research (April 14, 2003)
The European Parliament's decision on the proposal for standards of quality and safety of human tissues and cells (see BioCentury, April 14, 2003).

Medicare (April 14, 2003)
Congressional testimony on Medicare by David Walker (PDF file), U.S. comptroller genera (see BioCentury, April 14, 2003).

Nasal drug delivery (PDF file) (April 7, 2003)
Draft FDA guidance on the bioavailability and bioequivalence studies for nasal aerosols and nasal sprays for local action.

Medical Research Council (March 31, 2003)
House of Commons report (PDF file), "The Work of the Medical Research Council." (see BioCentury, March 31, 2003).

PDUFA (PDF file) (March 31, 2003)
HHS Inspector General’s report on the effects of mandated deadlines on FDA’s performance of NDA reviews (see BioCentury, March 31, 2003).

FDA regulatory metrics (March 24, 2003)
— Number of original INDs received and the number of active INDs at the close of calendar years 1986-2002 (see BioCentury Extra, Wednesday March 19).
— NDA approvals in 2003.

Diagnostics (PDF file) (March 17, 2003)
FDA draft guidance on reporting statistical results from studies evaluating diagnostic tests.

Multiple sclerosis (March 17, 2003)
NICE points to consider for a second consultation on a clinical practice guideline for multiple sclerosis.

Human growth hormone (March 10, 2003) 
NICE appraisal consultation document on the use of hGH to treat human growth deficiency.

Manufacturing (February 24, 2003)
— FDA progress report on its "risk-based approach" to cGMP.

Gene therapy trials (February 17, 2003)
The Afssaps French health authority statement relating aberrant LM0-2 function in two gene therapy patients in a French trial in X-linked severe combined immunodeficiency (X-SCID) (see BioCentury Extra, Thursday Feb. 13).

Antibacterial drugs (PDF file) (February 10, 2003)
Final FDA rule on the labeling requirements for systemic antibacterial drug products for human use to reduce development of antibiotic-resistant bacterial strains.

Estrogen therapies (PDF file) (February 10, 2003)
FDA draft guidance on prescribing and labeling for noncontraceptive estrogen drug products for vasomotor symptoms and vulvar and vaginal atrophy symptoms.

Pediatric trials (PDF file) (February 10, 2003)
FDA draft guidance on nonclinical safety evaluation of pediatric drug products.

Bioavailability (PDF file) (February 3, 2003)
FDA guidance on food-effect bioavailability and fed bioequivalence studies.

Drug access (PDF files) (February 3, 2003)
University of Erlangen-Nuremberg study "Diffusion of Medicines in Europe" and a summary presentation (see BioCentury, Feb. 3, 2003).

Product documentation (January 20, 2003)
— Aldurazyme: FDA briefing documents and questions for the Jan. 15, 2003, meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to review Aldurazyme laronidase to treat Mucopolysaccharidosis I, from BioMarin Pharmaceutical Inc. (BMRN; SWX:BMRN) and Genzyme General (GENZ).
— Fabrazyme: FDA briefing documents and questions for the Jan. 13, 2003, meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to review Fabrazyme agalsidase beta to treat Fabry's disease, from Genzyme General (GENZ) (see BioCentury, Jan. 20, 2003).
— Replagal: FDA briefing documents and questions for the Jan. 14, 2003, meeting of the Endocrinologic and Metabolic Drugs Advisory Committee to review Replagal agalsidase alfa to treat Fabry's disease, from Transkaryotic Therapies Inc. (TKTX) (see BioCentury, Jan. 20, 2003).

Amgen v Transkaryotic (January 13, 2003)
Ruling by the U.S. Court of Appeals for the Federal Circuit in the patent litigation between Amgen Inc. and Transkaryotic Therapies Inc. regarding erythropoietin (EPO) (see BioCentury, Jan. 13, 2003).

Drug approvals (January 13, 2003)
NDAs approved by CDER in 2002.
New molecular entities (NMEs) approved by CDER in 2002.

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