FDA Advisory Meetings（７月20日）
公開日時 2009/07/23 04:00
| Recent And Upcoming FDA Advisory Meetings |
| Topic |
Advisory Committee |
Date |
| Discussion of risk management and other possible solutions for reducing liver problems linked to the misuse of acetaminophen in OTC and prescription products |
Nonprescription Drug, Drug Safety and Risk Management and Anesthetic and Life Support Drugs |
June 29-30 |
| Centocor Ortho Biotech Products' Yondelis (trabectedin) for use in combination with Doxil (doxorubicin injection) to treat relapsed ovarian cancer, and the sNDA for Doxil in combination with docetaxel for locally advanced or metastatic breast cancer |
Oncologic Drugs |
15-Jul |
| Discussion of clinical trials to support use of vaccines against the 2009 H1N1 influenza virus |
Vaccines and Related Biological Products |
23-Jul |
| King Pharmaceuticals' binodenoson for use as a short-acting coronary vasodilator in adjunct with noninvasive myocardial imaging tests to detect perfusion abnormalities in patients with known or suspected coronary artery disease |
Cardiovascular and Renal Drugs |
28-Jul |
| Boehringer Ingelheim's telmisartan tablets for reduction in the risk of myocardial infarction, stroke, death from cardiovascular causes or hospitalization for congestive heart failure in high-risk patients 55 years or older |
Cardiovascular and Renal Drugs |
29-Jul |
| Schering-Plough's Saphris (asenapine) for acute treatment of schizophrenia and acute treatment of manic or mixed episodes of bipolar I disorder, both in adults |
Psychopharmacologic Drugs |
30-Jul |
| Discussion of bioequivalence recommendations for oral vancomycin hydrochloride capsule drug products |
Pharmaceutical Science and Clinical Pharmacology Committees |
Aug. 4 |
| Committee will hear status updates from Office of Generic Drugs on bioequivalence for highly variable drugs, presentations from Office of Pharmaceutical Science on the scientific and regulatory challenges of transdermal drug delivery systems, and other issues |
Pharmaceutical Science and Clinical Pharmacology Committees |
Aug. 5 |
| GE Healthcare's radiopharmaceutical DaTSCAN (ioflupane I 123 injection) for a special type of brain imaging in patients with movement disorders |
Peripheral and Central Nervous System Drugs |
Aug. 11 |
| Amgen's Prolia (denosumab) for treatment and prevention of osteoporosis in postmenopausal women, and for treatment and prevention of bone loss in patients undergoing hormone ablation for prostate or breast cancer |
Reproductive Health Drugs |
Aug. 13 |
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