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C******d
发帖数: 40 | 3 【 以下文字转载自 Pharmaceutical 讨论区 】
发信人: Coldhand (凉), 信区: Pharmaceutical
标 题: 替哥们儿发个广告： FDA招人
发信站: BBS 未名空间站 (Fri Dec 19 10:00:20 2014, 美东)
不负责回答问题，就是单纯替哥们儿发布一下消息(因为觉得挺好的机会还是多留给国
人比较好）：
招人的部门是FDA里Center of Drug Evaluation and Research (CDER)里Office of
Generic Drugs (OGD)。地点在silver spring, MD。
Position是ORISE fellow。这是一个临时性的职位，合同制，不属于政府职员，没有政
府职员的福利，跟博士后差不多，但是工资比一般的博士后要高不少 （不负责任地表
示，听说是大几万的样子）。前面几届的基本上都留下转成正式员工了。没有
benchwork, 工作环境就是办公室，搞文档工作的。
简单的工作广告如下：
Evaluate the relationship of complex drug prod... 阅读全帖 |
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C******d
发帖数: 40 | 4 【 以下文字转载自 Pharmaceutical 讨论区 】
发信人: Coldhand (凉), 信区: Pharmaceutical
标 题: 替哥们儿发个广告： FDA招人
发信站: BBS 未名空间站 (Fri Dec 19 10:00:20 2014, 美东)
不负责回答问题，就是单纯替哥们儿发布一下消息(因为觉得挺好的机会还是多留给国
人比较好）：
招人的部门是FDA里Center of Drug Evaluation and Research (CDER)里Office of
Generic Drugs (OGD)。地点在silver spring, MD。
Position是ORISE fellow。这是一个临时性的职位，合同制，不属于政府职员，没有政
府职员的福利，跟博士后差不多，但是工资比一般的博士后要高不少 （不负责任地表
示，听说是大几万的样子）。前面几届的基本上都留下转成正式员工了。没有
benchwork, 工作环境就是办公室，搞文档工作的。
简单的工作广告如下：
Evaluate the relationship of complex drug prod... 阅读全帖 |
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c**p
发帖数: 1443 | 7 which center are you in?
I know at least CDER and CDRH are good for non-citizen, non-GC, not
contractor, but federal employee. |
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n******p
发帖数: 283 | 8 GSK, PA,
BMS, NJ,
PPD,NC
FDA, CDER
major: statistics,
which one should I choose? |
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g**p
发帖数: 32 | 11 You have to be a US citizen in order for federal agency, unless you work as
a contractor. |
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I*****y
发帖数: 6402 | 12 不过倒是见过有绿卡持有者在CDC全职工作
as |
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g**p
发帖数: 32 | 13 Working at CDC不等于employee of CDC.
连VA medical center的工作都要求是公民. |
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d**l
发帖数: 1546 | 18 请问FDA网站上哪里有已批准的BLA的查询？
就类似CDER的Drugs at FDA? Thank you |
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L******r
发帖数: 522 | 22 楼上的基本都有一定道理。很多资料都是公开的，这是为什么可以file (505)(b)(2)，
但是并不是所有的资料都公开，或者说，我不知道哪里能找到所有的详细的申报资料。
通常的办法是以下几个：
1. 去drugs@fda, http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
查你需要查的 drug name（如果你输入generic name，记得找最原始的brand)，你会看
到一个drug detail的页面，那里有一个链接“Approval History, Letters, Reviews,
and Related Documents”，点击，找到approval history里面最早的那个approval,
一般都会有个"review"的链接，点击进去就可以看到最原始的申请审批材料。不过如前
所述，很多敏感关键的东西都black out了。
2. 你去注意读approved label，会有很多有用信息。
3. 如果这个药在欧洲也被批准，去欧洲找，信息会全面得多，以下这个链接：
http://ww... 阅读全帖 |
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h*******o
发帖数: 4884 | 23 well, somebody I knew just get their IND approved for Phase I and IIa trials
on a combinational formulation, which includes three compounds.
Also, think about drug/device combo,
none of them will likely to work if administered alone. althought a Little
bit more complicated, it is still pretty much the same process. depends on
its primary mechanisms of action, it may go to CDER or CDRH. |
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g*******n
发帖数: 74 | 26 Would you mind sharing with me how you get to work at FDA? Any requirements
? Or if you look at my background and my wife's, can you tell me how much
opportunity do we have to get a position at FDA /CDER?
My wife's:
BS in pharmacy from China pharmaceutical Univ. PhD in pharmacology from
Peking Union Medical College, postdoc training in Neuroscience at Washington
University and Harvard Medical School.
Mine:
BS in pharmacy from Fudan Univ.; M.S in pharmacology from Peking Union
Medical College. ... 阅读全帖 |
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C******d
发帖数: 40 | 28 不负责回答问题，就是单纯替哥们儿发布一下消息(因为觉得挺好的机会还是多留给国
人比较好）：
招人的部门是FDA里Center of Drug Evaluation and Research (CDER)里Office of
Generic Drugs (OGD)。地点在silver spring, MD。
Position是ORISE fellow。这是一个临时性的职位，合同制，不属于政府职员，没有政
府职员的福利，跟博士后差不多，但是工资比一般的博士后要高不少 （不负责任地表
示，听说是大几万的样子）。前面几届的基本上都留下转成正式员工了。没有
benchwork, 工作环境就是办公室，搞文档工作的。
简单的工作广告如下：
Evaluate the relationship of complex drug products' quality and clinical
performance.
Contribute to bioequivalence guidances and postmarketing investigations
Positions open to Ph.D. i... 阅读全帖 |
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j********t
发帖数: 201 | 29 got your message from private box - sorry to reply late:
a few things that might be useful, but please contact your regulatory
department for the final formats:
1) even for non-cdisc compliant submission, it's useful to provide a define.
xml(use proc contents, ods tagsets.excel) and define.pdf (refers to http://www.lexjansen.com/pharmasug/2012/AD/PharmaSUG-2012-AD14.pdf).
2) limit length of variable names to 8 even SAS 9.2 or later goes beyond
that. (label length = 40).
3) make xpt files that le... 阅读全帖 |
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s**********8
发帖数: 25265 | 30 Center for Devices and Radiological Health
From Wikipedia, the free encyclopedia
Jump to: navigation, search
The Center for Devices and Radiological Health (CDRH) is the branch of the
United States Food and Drug Administration (FDA) responsible for the
premarket approval of all medical devices, as well as overseeing the
manufacturing, performance and safety of these devices. The CDRH also
oversees the radiation safety performance of non-medical devices which emit
certain types of electromagnetic... 阅读全帖 |
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s**********8
发帖数: 25265 | 31 CDER and CDRH share responsiblities when combo products are concerned.
emit |
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s**********8
发帖数: 25265 | 32 Frequently Asked Questions About the IRB:
The following is a compilation of questions frequently asked regarding
Institutional Review Boards, human subject protection and compliance with
federal regulations. These questions are organized according to whether they
pertain to:
I. Institutional Review Board regulations;
II. Informed Consent regulations;
III. Clinical investigations involving drugs;
IV. Clinical investigations involving medical devices; and
V. Other
I. INSTITUTIONAL REV... 阅读全帖 |
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s**********8
发帖数: 25265 | 33 Federal Food, Drug, and Cosmetic ActFrom Wikipedia, the free encyclopedia (
Redirected from 510k)
Jump to: navigation, search
This article may require cleanup to meet Wikipedia's quality standards.
Please improve this article if you can. The talk page may contain
suggestions. (February 2011)
Federal Food, Drug, and Cosmetic Act
Acronym FFDCA, "FD&C Act"
Enacted by the 75th United States Congress
Citations
Public Law 75-717
Stat. 52 US Stat. 1040
Codification
U.S.C. sections created 21 U.S.C. §... 阅读全帖 |
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s**********8
发帖数: 25265 | 34 .....FDA regulates all health care products, dont just go with names.
CDER: center for drug evalutation and research, basically small molecule
chemical drug
CBER: center for biologics evaluation and research.
CDRH: center for devices and radigological health |
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s**********8
发帖数: 25265 | 35 European Medicines Agency
The European Medicines Agency (EMA) is a European agency for the evaluation
of medicinal products. From 1995 to 2004, the European Medicines Agency was
known as European Agency for the Evaluation of Medicinal Products.[1]
Roughly parallel to the U.S. Food and Drug Administration (FDA), but without
FDA-style centralization, the European Medicines Agency was set up in 1995
with funding from the European Union and the pharmaceutical industry, as
well as indirect subsidy fr... 阅读全帖 |
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k****i
发帖数: 1126 | 36 see the definition of medical device by FDA.
As long as one of the following is combined with a drug, it is called
combination.
Medical Device Definition
Medical devices range from simple tongue depressors and bedpans to complex
programmable pacemakers with micro-chip technology and laser surgical
devices. In addition, medical devices include in vitro diagnostic products,
such as general purpose lab equipment, reagents, and test kits, which may
include monoclonal antibody technology. Certain ele... 阅读全帖 |
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a*i
发帖数: 1652 | 37 Medical Device Definition
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/O
Medical devices range from simple tongue depressors and bedpans to complex
programmable pacemakers with micro-chip technology and laser surgical
devices. In addition, medical devices include in vitro diagnostic products,
such as general purpose lab equipment, reagents, and test kits, which may
include monoclonal antibody technology. Certain electronic radiation
emitting products3 with medical application an... 阅读全帖 |
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U***J
发帖数: 5998 | 40 I know he is a CMC reviewer from CDER. |
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