 |
 |
 |
 |
 |
 |
||
 |
 |
 |
 |
 |
| 5 | 1/1 | 返回列表 |
| 查看: 1865 | 回復(fù): 2 | ||
| 當(dāng)前只顯示滿足指定條件的回帖，點(diǎn)擊這里查看本話題的所有回帖 | ||
[求助]
美國(guó)FDA認(rèn)證的所有材料的目錄 已有1人參與
|
||
| 美國(guó)FDA認(rèn)證了哪些藥物和材料？請(qǐng)大神告訴到哪里可以查到或者有相關(guān)的目錄？跪謝 |
回復(fù)此樓» 猜你喜歡
丙酮酸激酶的抑制劑和激動(dòng)劑
已經(jīng)有1人回復(fù)
-
家人們做LDH為啥會(huì)出現(xiàn)負(fù)值啊
已經(jīng)有0人回復(fù)
-
藥理學(xué)論文潤(rùn)色/翻譯怎么收費(fèi)?
已經(jīng)有188人回復(fù)
-
求購(gòu)時(shí)間長(zhǎng)一些的硝酸釷
已經(jīng)有0人回復(fù)
-
有償求腸毒素的脆弱擬桿菌（ETBF）
已經(jīng)有0人回復(fù)
» 本主題相關(guān)商家推薦: (我也要在這里推廣)
» 本主題相關(guān)價(jià)值貼推薦，對(duì)您同樣有幫助:
- 請(qǐng)問(wèn)國(guó)外已經(jīng)上市FDA認(rèn)證藥品在國(guó)內(nèi)注冊(cè)按3類申報(bào)總共需要多長(zhǎng)時(shí)間能拿證？
已經(jīng)有5人回復(fù)
- 2011美國(guó)FDA工藝驗(yàn)證指南
已經(jīng)有89人回復(fù)
- 如何在美國(guó)FDA網(wǎng)站上查找新分子實(shí)體藥物？
已經(jīng)有4人回復(fù)
- 請(qǐng)教如何查詢美國(guó)食品藥物管理局(FDA)認(rèn)證過(guò)哪些藥物？
已經(jīng)有5人回復(fù)
- 關(guān)于FDA藥品劑型的問(wèn)題
已經(jīng)有8人回復(fù)
- FDA發(fā)布的最新指導(dǎo)原則201402：藥物分析程序及方法驗(yàn)證指導(dǎo)原則
已經(jīng)有171人回復(fù)
- 經(jīng)過(guò)美國(guó)FDA批準(zhǔn)的中國(guó)藥品匯總
已經(jīng)有25人回復(fù)
- 關(guān)于查詢美國(guó)FDA
已經(jīng)有6人回復(fù)
- 一個(gè)上市多年的藥美國(guó)藥典、歐洲藥典，F(xiàn)DA數(shù)據(jù)庫(kù)里都找不到信息
已經(jīng)有14人回復(fù)
- 方達(dá)醫(yī)藥(中國(guó))臨床研究中心和生物分析實(shí)驗(yàn)室成功通過(guò)美國(guó)FDA檢查
已經(jīng)有13人回復(fù)
- 未通過(guò)FDA認(rèn)證的中國(guó)藥企，能否向美國(guó)FDA提出ANDA(簡(jiǎn)明新藥申請(qǐng))？
已經(jīng)有2人回復(fù)
- 塑料的FDA認(rèn)證
已經(jīng)有5人回復(fù)
- FDA會(huì)認(rèn)可中國(guó)做的數(shù)據(jù)嗎
已經(jīng)有4人回復(fù)
- 如何查詢通過(guò)FDA認(rèn)證的食品添加劑？
已經(jīng)有8人回復(fù)
- 怎樣從美國(guó)FDA網(wǎng)站上查找及下載藥品說(shuō)明書(shū)？
已經(jīng)有11人回復(fù)
- 【求助】藥品DMF編寫(xiě)
已經(jīng)有9人回復(fù)
- 【轉(zhuǎn)帖】美國(guó)FDACGMP現(xiàn)場(chǎng)檢查指南.pdf
已經(jīng)有46人回復(fù)
- 【轉(zhuǎn)帖】海普瑞“獨(dú)家FDA認(rèn)證”的解析
已經(jīng)有9人回復(fù)
3樓2015-04-15 08:41:49
【答案】應(yīng)助回帖
感謝參與，應(yīng)助指數(shù) +1
|
New Molecular Entity and New Therapeutic Biological Product Approvals for 2015 No. Drug Name Active Ingredient Date FDA-approved use on approval date 10. Cholbam cholic acid 3/17/2015 To treat pediatric and adult patients with bile acid synthesis disorders due to single enzyme defects, and for patients with peroxisomal disorders Press Release 9. Unituxin dinutuximab 3/10/2015 To treat pediatric patients with high-risk neuroblastoma Press Release 8. Cresemba capsule injection isavuconazonium sulfate 3/6/2015 To treat adults with invasive aspergillosis and invasive mucormycosis, rare but serious infections Press Release 7. Avycaz ceftazidime-avibactam 2/25/2015 To treat adults with complicated intra-abdominal infections (cIAI), in combination with metronidazole, and complicated urinary tract infections (cUTI), including kidney infections (pyelonephritis), who have limited or no alternative treatment options. Press Release 6. Farydak panobinostat 2/23/2015 To treat patients with multiple myeloma Press Release 5. Lenvima lenvatinib 2/13/2015 To treat patients with progressive, differentiated thyroid cancer (DTC) whose disease progressed despite receiving radioactive iodine therapy (radioactive iodine refractory disease). Press Release 4. Ibrance palbociclib 2/3/2015 To treat advanced (metastatic) breast cancer Press Release 3. Natpara parathyroid horomone 1/23/2015 To control hypocalcemia (low blood calcium levels) in patients with hypoparathyroidism Press Release 2. Cosentyx secukinumab 1/21/2015 To treat adults with moderate-to-severe plaque psoriasis Press Release 1. Savaysa edoxaban 1/8/2015 To reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problem Press Release |
2樓2015-04-14 16:34:23
| 最具人氣熱帖推薦 [查看全部] | 作者 | 回/看 | 最后發(fā)表 | |
|---|---|---|---|---|
