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Advisory Committee |
Date |
| Development of anti-nerve growth factor drugs, including safety issues such as whether reports of joint destruction represent a safety signal and whether the risk-benefit balance favors continued development of these drugs as analgesics |
Arthritis |
12-Mar |
| Appropriate target populations, objectives and designs of trials intended to evaluate products for the control of hyperbilirubinemia in newborns |
Gastrointestinal Drugs |
13-Mar |
| Clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development |
Pharmaceutical Science and Clinical Pharmacology |
14-Mar |
| GlaxoSmithKline's Votrient (pazopanib) for patients with advanced soft tissue sarcoma who have received prior chemotherapy |
Oncologic Drugs |
20-Mar |
| Merck Sharp & Dohme's Taltorvic (ridaforolimus) for metastatic soft tissue sarcoma or bone sarcoma as a maintenance therapy for patients who have completed at least four cycles of chemotherapy without evidence of disease progression |
Oncologic Drugs |
20-Mar |
| Talon Therapeutics’ Marqibo (vincristine sulfate liposomes injection) for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia in second or greater relapse or whose disease has progressed following two or more lines of anti-leukemia therapy |
Oncologic Drugs |
21-Mar |
| Shire Human Genetics Therapies' Replagal (agalsidase alfa) as an enzyme replacement therapy for Fabry disease |
Cardiovascular and Renal Drugs |
27-Mar |
| The role of cardiovascular assessment in the pre- and post-approval settings for obesity drugs and biologics |
Endocrinologic and Metabolic Drugs |
March 28-29 |
| Consumer studies needed to assess proper use of a MedKit containing doxycycline to be taken in the event of anthrax exposure |
Anti-Infective Drugs and Nonprescription Drugs |
2-Apr |
| Development of an animal model of pneumonic plague in African Green Monkeys and its relevance to pneumonic plague in humans resulting from exposure to Yersinia pestis in a bioterrorism event; safety and efficacy of ciprofloxacin to treat pneumonic plague |
Anti-Infective Drugs |
3-Apr |
| Safety and efficacy of Janssen Pharmaceuticals' Levaquin (levofloxacin) to treat pneumonic plague |
Anti-Infective Drugs |
4-Apr |
| Astellas' mirabegron for treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and urinary frequency |
Reproductive Health Drugs |
5-Apr |
| Regeneron Pharmaceuticals' Arcalyst (rilonacept) to prevent gout flares during initiation of uric acid-lowering therapy in adult patients with gout |
Arthritis |
8-May |
| Pfizer’s tofacitinib for adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs |
Arthritis |
9-May |