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h*******o
发帖数: 4884 | 2 Dont be misleading.
Dietary supplement is a special category that doesn't requrie FDA clearance/
approval for marketing.
And still dietary supplements cannot have disease claim (which most products
in China do)
However, the majority of medical products require, more or less, FDA
approval.
Drugs require 505 (b1/b2/j), Device needs 510k or PMA.
Biologics need BLA, etc. |
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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******d
发帖数: 40 | 5 【 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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b**********t
发帖数: 353 | 6 天士力的复方丹参滴丸通过了FDA的II期临床试验，成为第一个通过FDA II期临床的中
药。
N多年前，天士力的丹参滴丸的国内年销售额就超过了10亿，现在他们门口的石头狮子
可以换更大的了,呵呵 |
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l****z
发帖数: 29846 | 7 当然, 说有效但FDA不会批的就是没见过世面的傻冒.
我用过一种处方漱口水,里面告诉你它含有什么成分,说对什么什么有效.但清楚的写明:
为什么有效的原理是unknown.
只要有效,不一定要知道机理的. FDA也会批准.当然有那个毒性试验先. |
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j*******1
发帖数: 266 | 8 "中医怎么不能双盲？"
我是说中医怎么不能按FDA的标准双盲，FDA要求知道什么是有效成分，中药的成分成百
上千，哪种或哪几种是有效成分？而以科研为目的，看看它们是否有效的双盲实验很多
，你自己google 一下就可发现。
"全世界专利法当中只有中药有保密配方，"
你是无知无畏。什么叫专利？得到专利的基本条件是公开，哪个中药有保密配方？商业
秘密可以保密，如coco cola的配方, 那不是什么专利。 |
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f*******e
发帖数: 5594 | 9 也拜托你不要见风就是雨的，最好等FDA审批通过再说。有人愿意花钱是一回事，FDA审
批通过又是一回事。这方面同是反中医的新语丝就要比你专业多了。
吧。
”。 |
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c**p
发帖数: 1443 | 10 Currently, we have an ORISE fellowship open at our FDA lab in St. Louis MO f
or postdoc or a graduate student to work on an FDA critical path project tit
led "Advanced methods for in vitro testing of inhalation products". The proj
ect mainly involves measuring particle size and velocity of inhalation drugs
using our newly purchased Phase Doppler particle analyzer. Other advance ae
rosol characterization techniques will also be used as parellel studies usin
g facilities in an aerosol lab in Washi |
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w*********s
发帖数: 2136 | 11 【 以下文字转载自 Parenting 讨论区 】
发信人: whiteclouds (/ 参考消息 /), 信区: Parenting
标 题: FDA Recalled Rotarix Vaccine
发信站: BBS 未名空间站 (Sat Apr 17 21:26:46 2010, 美东)
The FDA Shuts Down Common Infant Vaccine After Startling Discovery
Posted by Dr. Mercola | April 17 2010 | 139,215 views
Part 1.
“U.S. federal health authorities recommended … that doctors suspend using
Rotarix, one of two vaccines licensed in the U.S. against rotavirus, saying
the vaccine is contaminated with material from a pig virus,” CNN report |
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f*********7
发帖数: 1040 | 12 我现在是resident.
我想买一些医疗器械online。但是online卖家say
"The sale of this item may be subject to regulation by the U.S. Food and
Drug Administration and state and local regulatory agencies. If the item is
subject to FDA regulation, I will verify your status as an authorized
purchaser of this item before shipping of the item."
什么是FDA authorized purchaser?
怎样才能是authorized purchaser?
thanks |
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b*r
发帖数: 31 | 13 A friend of mine could possibly get a job at FDA.
How about it? I heard that they paid pretty low, compare to
the companies. Is it a good chance to work for FDA?
Does anyone know about it?
Much thanks |
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m**b
发帖数: 617 | 14 I can't believe Genetech would intentionally reduce the amount of antibody.
Anyone in the pharma industry would know it's totally unworthy of the risk
to do some stupid dirty trick like this. FDA often pays unanounced visits
to manufaturing sites and R&D sites to do tests. If a company was found out
to intentionally lower the dose, it will cause them big problem. If you
are really confident about your findings, why not contact FDA?
antibody
as |
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d*********e
发帖数: 15 | 15 I measured original solution without desalting too and uv 280 reading was
consistent with concentration after desalting. Just very very high uv260
reading. What would cause high uv 260 reading ? It is not nucleic acid.
After desalting, uv280 >uv260.(something like uv280 0.4, uv260 0.2.).
Did FDA come to measure protein concentration ? I doubt it.
FDA should measure protein concentration from samples randomly taking from
phamacy.
There are a lot of pharma dirty things exposed before, such as |
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d*********e
发帖数: 15 | 16 I have not yet received responses from either FDA or DNA.
I filled out an online form (non-emergent) in FDA website, and sent an email
to DNA on its website website.
DNA is such huge biotech company that I do not wish to get retaliated.
Anyone would like to confirm it, just check the concentration if you happen
to have one.
Thanks, |
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t******t
发帖数: 22 | 17 小弟知道在美国销售的药品要通过FDA认证，同时也要满足USP标准。另外USP做些认证
和培训的工作。但不是太清楚USP认证到底是怎么操作的？USP和FDA的关系是怎么样的
？有那些差别呢？
请各位前辈赐教。谢谢 |
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d**l
发帖数: 1546 | 19 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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m****n
发帖数: 1066 | 22 想看看FDA的工作机会。
是去FDA的网站？
还是indeed.com?
那个资源多些。
Xiexie。 |
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l*u
发帖数: 2090 | 23 家里有人负责卖广告
有中国国内保健品厂商要买广告版面
声称他们的保健品通过 美国 FDA认证
请问如何调查保健品 “FDA认证”是否属实呢？
多谢指教 ！！ |
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n*****y
发帖数: 237 | 24 国内的朋友对一个FDA批了的药比较感兴趣。想找找FDA当时的申请资料。请问怎么才能
搞到？跪谢阿。 |
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j*******1
发帖数: 266 | 26 “For the type 3 diseases, it is more towards a physician practice
regulation
which FDA has no authority over.”
A physician only can drugs on market, the phase IV clinical or post market
monitoring only apply drugs on market. What I said that the type 3 disease
can be well treated only by a group of medication which did not work
effectively if separately used in the trial, but work in a group or other compounds in the trials. Those kinds of compound will never go into market.
AID is the type 2 di... 阅读全帖 |
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h*******o
发帖数: 4884 | 27 thearetically, physician can almost use anything they have access to and FDA
has no authority over their practices.
of course, no physician will risk their career over something they have no
confidence.
As for combination drugs, of course fDA has guidelines. this is true for
drugs and for drug/device combos, as long as the IND/NDA is clear about
their mechanisms of action or active ingredients.
again, the biggest chanllenge for TCM is QA and GMP, not their synergistic
mechanism of action.
as for... 阅读全帖 |
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j*******1
发帖数: 266 | 28 FDA has no guidelines against combo, however due to high cost of the trials,
no company can afford to do a trial with combo.
If it takes $1.5 billions to have one compound drug into market, how much
does it take to have three compounds drug into market? Which company can
afford that kind of risk?
Do you have any example that a drug company test two more more unknown
compounds in the same trial?
FDA
. |
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j*******1
发帖数: 266 | 29 Where did I say FDA against combo drugs?
Where did I say FDA covering every aspect of the medical
product?
,
medical |
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h*******o
发帖数: 4884 | 30 more over you seem to forget that the biggest cost for a drug is not
manufacture or regulatory fees, not even clinical trials. Sales and
marketing. takes the largest portion of the cost.
FDA's job is to review the risk/benefit profile of the medical product.
Combo or not is not the primary factor to consider.
Also it does not cost much more to conduct trials on combo drug than single
molecule. Again, the problem does not stays on the FDA side, but the R D
strategy. |
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j*******1
发帖数: 266 | 31 YES. That does not mean FDA against combo. FDA does not oppose combo if you
have money to do that, however high cost make it almost impossible.
So far, how much drugs on the market which is developed by testing 2 or 3
NCEs. Fact talks.
Do not tell some trials will start or finish. |
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j*******1
发帖数: 266 | 32 你是应该对自己哭笑不得。
我什么时候说Elvitegravir和cobicistat没啥用？ FDA不要为人民服务，难道人民要为
FDA服务？你以为美国是中国哪 |
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r******0
发帖数: 2753 | 33 开始我还以为我明白你在讲什么，到后面我是越看越糊涂。第三类药很少，这完全是市
场机制造成的，
管FDA什么事啊。那你觉得FDA应该怎么做才对呢？放松对第三类药的要求，让它们更容
易被批准？化学
机理不明或者可以，但要在QA/QC上放松是很难的。 |
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c********g
发帖数: 1106 | 34 对于你的第三类，这不是FDA的问题，是整个生物医学研究和制药公司面临的重大挑
战。难度远远高于单一构成的药。比方说，有确作证据支持某个病由A和B两个信号
通路障碍引起，那修正这两个通路的药物如何配比（1：1，1:x, x:1?）能达到最大
效应，各种配比，各配比的不同剂量，想想临床试验得要多大。
在方法学上，相比于西药研究，中医对第三类毫无优势。中医药唯一优势是几千年
免费临床试验积累下来的丰富知识和庞大数据库。直接强调这个优势就得了，没必
要通过攻击FDA来显示你的观点可靠。 |
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h*****a
发帖数: 871 | 35 LZ 说过type3基本属于机理未知，而需要通过多把钥匙来反推锁的结构。
从FDA的角度来说这类病应该是死了活该，或者病人自己找江湖郎中或中医开药，死活
与FDA及整个health care从经济上或者责任上都无关。
从现实上说是不是block了反推法的研究？就好像是从数学中取消了反证法？ |
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j*******1
发帖数: 266 | 36 是什么市场机制造成的不能生产治第三类病的药？全世界每年有7.5 millions 的人死于癌症，你能说没有需求？我不知道管FDA什么事，我只是说FDA的机制治不了第三类病。 |
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h*******o
发帖数: 4884 | 37 Again, you seem to quite lack basic knowledge of how FDA works.
FDA as a regulatory agency review your medical product profile, not provide
inspiration of your research and development activities.
The sponsor aims to test the efficacy and safety of a combo drug, then it is
a combo drug. Not necessary to test the efficacy and safety of each
components. Otherwise it will be multiple applications for multiple drugs.
In reality, there are cases that a few drugs were marketed first and later
on make ... 阅读全帖 |
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g*******n
发帖数: 74 | 38 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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s*******i
发帖数: 1063 | 39 well said
I think regulatory affair is the way to go, plus CDER or CBER.
If you want to come to big pharms, with your experience in CBER or CDER,
plus the MS degree, you could potentially make a lot of money. The course
itself isn't that interesting. You may consider the certificate. It is a lot
of memory stuff with some practice.
It isn't quite practical to get the experience and work in China. Chinese
system is quite different, and is not appreciated by FDA. Human data used
for FDA approval is... 阅读全帖 |
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c***a
发帖数: 15 | 40 Thanks for your kind advice. I appreciate.
for now, I won't quit my FDA job and go to law firm. ignore the top 10 law
school, I just need a law degree + my FDA experience. I will definitely give
law school a try(LSAT is not EZ), and if I failed, I just go to MS program.
small |
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g********n
发帖数: 4054 | 41 Yes, FDA will only make sure your labeling is correct and monitor your
advertising and promotional materials.
评价药物 is an important direction but so far only some academia-physician
groups promote this idea. I don't think FDA has such an authority. |
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w***u
发帖数: 17713 | 42 1.除了a拿到 orpahan status, FDA只管批，当然副作用造成死伤无数除外。
2.gerneric的批准也需要通过FDA,而且政府对于降低医疗开支还是鼓励的。现在的动向
是biosimilar了。 |
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a******y
发帖数: 44 | 43 要看试验的质量，是不是符合GCP标准。如果是用来在美国注册用，FDA估计首要作
inspection.目前国内的试验水平应该还达不到FDA的要求。国内的clinicial trial平
台大多是为了国内的注册服务的。 |
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l****n
发帖数: 711 | 44 搞质谱和bioinformatics方向的，老板推荐了一个FDA的博后职位，好像是搞食品检测
之类的吧，有没有在FDA做过博后的说说待遇和出路怎么样？ |
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m******8
发帖数: 123 | 45 很多人对fda的工作感兴趣。这里简单介绍，一家之言。
1。正式工，full time employee，各类专业职位都有，中国人比较多的是reviewer或
者是review相关的reseacher。正式工也分AD和GS。GS是真正意义的铁饭碗， AD是几年
一续的。因为两者的pay system一样，而且AD很稳定，可以干到死，很多人工作很长时
间也还不知道自己其实不是所谓的permenant job。 多数中国人都是AD，很多拿了公民
后，会转GS。AD的工作不是非要绿卡，也sponsor h1。说到底人家愿不愿招。
2。fellowship。一种commissioner fellow，要绿卡，其实是full time employee，但
是通常两年到期，走人或是转正，有名没份。orise fellow，其实是一种contractor，
待遇比一般postdoc好得多，不需要绿卡，opt就行，也是一两年转正或走人。我知道有
转正的有到其他地方找到工作的。
至于是fda好还是药厂好，这个不可一概而论，都有利弊，每个人情况不同。 |
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m******8
发帖数: 123 | 46 再多说几句：
1。找fda工作和找药厂工作类似，netwoking，运气，实力。信息无非是推荐，专业会
议，网上专业论坛等。usajob我不熟。
2。fellow转正完全可能，但是受很多因素影响。
3。很多高的职位只有GS，也就是要求公民。更高职位还有其他非GS的类别，GS的上限
低。但是同一级的GS和AD工资一样。
4。钱。对fresh或者没啥经验的人来说，和药厂的entry base差不多。但是这点对于不
同专业情况会不同。一般来说，经验越多，和药厂的收入差距越大。因为fda是按步就
班的一点一点升step，级别高了要几年才升一step。一step也就2，3k，税前。 |
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s******y
发帖数: 188 | 47 继续诚心请教，我博士毕业好几年了，以前的专业和研究和医药一点关系也没有，工作
几年的经验和医药也完全不占边。拿到FDA的工作也是机缘凑巧，现在纠结的是不是要
接。一方面不知道能不能胜任，会不会工作起来很吃力。二是前面有个ID说我这种就是
输在起跑线上（BTW，那个贴子怎么没了，不过感谢那个作者提出中肯的意见），我其
实对工作也没太大野心，能安安稳稳，稳中有升就好。不知道FDA的reviewer的career
path都是怎么样的，希望那里工作的朋友出来说说，谢谢。 |
|
m******8
发帖数: 123 | 48 很多人对fda的工作感兴趣。这里简单介绍，一家之言。
1。正式工，full time employee，各类专业职位都有，中国人比较多的是reviewer或
者是review相关的reseacher。正式工也分AD和GS。GS是真正意义的铁饭碗， AD是几年
一续的。因为两者的pay system一样，而且AD很稳定，可以干到死，很多人工作很长时
间也还不知道自己其实不是所谓的permenant job。 多数中国人都是AD，很多拿了公民
后，会转GS。AD的工作不是非要绿卡，也sponsor h1。说到底人家愿不愿招。
2。fellowship。一种commissioner fellow，要绿卡，其实是full time employee，但
是通常两年到期，走人或是转正，有名没份。orise fellow，其实是一种contractor，
待遇比一般postdoc好得多，不需要绿卡，opt就行，也是一两年转正或走人。我知道有
转正的有到其他地方找到工作的。
至于是fda好还是药厂好，这个不可一概而论，都有利弊，每个人情况不同。 |
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m******8
发帖数: 123 | 49 再多说几句：
1。找fda工作和找药厂工作类似，netwoking，运气，实力。信息无非是推荐，专业会
议，网上专业论坛等。usajob我不熟。
2。fellow转正完全可能，但是受很多因素影响。
3。很多高的职位只有GS，也就是要求公民。更高职位还有其他非GS的类别，GS的上限
低。但是同一级的GS和AD工资一样。
4。钱。对fresh或者没啥经验的人来说，和药厂的entry base差不多。但是这点对于不
同专业情况会不同。一般来说，经验越多，和药厂的收入差距越大。因为fda是按步就
班的一点一点升step，级别高了要几年才升一step。一step也就2，3k，税前。 |
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s******y
发帖数: 188 | 50 继续诚心请教，我博士毕业好几年了，以前的专业和研究和医药一点关系也没有，工作
几年的经验和医药也完全不占边。拿到FDA的工作也是机缘凑巧，现在纠结的是不是要
接。一方面不知道能不能胜任，会不会工作起来很吃力。二是前面有个ID说我这种就是
输在起跑线上（BTW，那个贴子怎么没了，不过感谢那个作者提出中肯的意见），我其
实对工作也没太大野心，能安安稳稳，稳中有升就好。不知道FDA的reviewer的career
path都是怎么样的，希望那里工作的朋友出来说说，谢谢。 |
|
