2. 仿制药(Generic Drug):仿制药是对已经获得FDA批准的原创药物的合成副本。仿制药需要提交通用药物申请(Abbreviated New Drug Application,ANDA),证明其与原创药在质量、安全性和效力方面的相似性。 3. 生物制品(Biological Products):这包括基因工程药物、生物类似物和血液制品等药物。生物制品需要通过生物制品许可申请...
42 U.S. Code § 262 - Regulation of biological products | U.S. Code | US Law | LII / Legal Information Institute (cornell.edu) Biologies Price Competition and Innovation Act of 2009 上文提到的《生物制品价格竞争与创新法案》(BPCIA),依据此法案可互换生物类似药与其参照产品生物类似,并且“可以预...
根据美国FDA紫皮书(Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations),在2000-2023年期间,共计98款原研生物药械组合产品被批准上市,其中包括16款胰岛素产品,19款疫苗产品及63款其他生物制品(单抗,双抗,细胞因子等)。胰岛素产品的注射通常采用可...
1.https://www.fda.gov/drugs/new-drugs-fda-cders-new-molecular-entities-and-new-therapeutic-biological-products/novel-drug-approvals-2023 2.https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/2023-biological-license-application-a...
美国FDA下属的药品评价与研究中心(CDER)2023年批准的55个新药中共有17个新的生物药,美国FDA下属的生物制品评价及研究中心(CBER)2023年批准的25个生物制品中共有18个新的生物药。 这35个新生物药按解剖学治疗学及化学(ATC)分类,则包括抗肿瘤和免疫机能调节用药,系统性抗感染用药,血液及血液形成器官用药,消化道及代...
笔者根据美国FDA官网的公开信息[1],解读2024年2月获FDA药物评估和研究中心(CDER)批准上市的药物。2024年2月FDA批准上市了2款药物:治疗复杂性尿路感染的Exblifep和肉毒杆菌毒素Letybo。以下文字内容大多参考自FDA官方的药物说明书,部分的数据除非特别引用,一般是参考维基百科和...
. The chosen biological indicator provides a means to measure the lethality of the process through the selection of biological indicator population and resistance. The sterilization process duration should not be adapted to accommodate the specifics of any biological indicator.应选择适合所选灭菌过程及其...
FDA-Regulated Products in Importation Jan 17, 2025 The U.S. Food and Drug Administration (FDA) plays a crucial role in regulating a significant portion of imports, overseeing about 40% of the U.S. GDP. FDA regulations impact various product categories, including: Food Products: FDA regulates...
correspondingtoaconcentrationlimitof5000ppmfordailydosesnotgreaterthan10goftheproductIfthemonographallowsforaconcentrationresultinginmorethan50mg/day,Class3solventsmustbeidentifiedandquantified.FDA对药物杂质的控制要求Table3.Class3ResidualSolventsAceticAcidEthylacetateMethyliobutylketoneAcetoneEthylether2-Methyl-1-...
. The FDA was established when the Pure Food and Drugs Act was passed in 1906.1The agency has different divisions that oversee a majority of the organization's obligations involving food, drugs, cosmetics, animal food, dietary supplements, medical devices, biological goods, and blood products.2...