FDA's Advisory Meetings（1月16日）
公開日時 2012/01/19 04:00
| Recent and upcoming FDA advisory committee meetings and a summary of topics covered. |
|
| Topic |
Advisory Committee |
Date |
| Columbia Labs and Watson Labs' Prochieve (progesterone vaginal gel 8%) for reduction of risk of preterm birth in women with short uterine cervical length |
Reproductive Health Drugs |
Jan. 20 |
| Pediatric-focused safety reviews under BPCA and PREA for various drugs |
Pediatric |
Jan. 31 |
| Amgen’s Xgeva (denosumab) for men with castrate-resistant prostate cancer at high risk of developing bone metastases |
Oncologic Drugs |
Feb. 8 |
| Eisai's Dacogen (decitabine) for acute myelogenous leukemia in patients over 65 who aren’t candidates for induction chemotherapy; Cell Therapeutics’ Pixuvri (pixantrone dimaleate) as monotherapy for relapsed or refractory aggressive Non-Hodgkin’s lymphoma |
Oncologic Drugs |
Feb. 9 |
| NeurogesX Inc.'s Qutenza (capsaicin 8%) patch for management of neuropathic pain related to HIV-associated peripheral neuropathy |
Anesthetic and Analgesic Drug Products |
Feb. 9 |
| Updates on research in CBER's Cellular and Tissue Branch |
Cellular, Tissue, and Gene Therapies |
Feb. 10 |
| Vivus’ Qnexa (phentermine/topiramate) as an adjunct to diet and exercise for weight management in patients with a BMI greater than or equal to 30 kg/m2 or a BMI greater than or equal to 27 kg/m2 if accompanied by weight-related comorbidities |
Endocrinologic and Metabolic Drugs |
Feb. 22 |
| Chelsea Therapeutics’ Northera (droxidopa) for symptomatic neurogenic orthostatic hypotension in patients with primary autonomic failure (Parkinson's Disease, Multiple System Atrophy, and Pure Autonomic Failure), Dopamine Beta-Hydroxylase Deficiency and Non-Diabetic Autonomic Neuropathy |
Cardiovascular and Renal Drugs |
Feb. 23 |
| Appropriate clinical evidence for developing anti-inflammatory drugs to treat postoperative inflammation and reduction of eye pain in patients who have undergone ocular surgery, and the appropriateness of marketing a single bottle of ophthalmic product, such as Ista Pharmaceuticals' Bromday (bromfenac ophthalmic solution 0.09%), for use in both eyes post-surgery, given risk of infection |
Dermatologic and Ophthalmic Drugs |
Feb. 27 |
| The 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 |
| Clinical pharmacology aspects of pediatric clinical trial design and dosing to optimize pediatric drug development |
Pharmaceutical Science and Clinical Pharmacology |
14-Mar |
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