s**********8
发帖数: 25265 | 1 来自主题: MedicalDevice版 - FDA The Food and Drug Administration (FDA or USFDA) is an agency of the United
States Department of Health and Human Services, one of the United States
federal executive departments. The FDA is responsible for protecting and
promoting public health through the regulation and supervision of food
safety, tobacco products, dietary supplements, prescription and over-the-
counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals,
blood transfusions, medical devices, electromagnetic radiati... 阅读全帖 |
|
C*I
发帖数: 4736 | 2 http://rt.com/usa/new-mexico-gmo-food-580/
After defeat in California, New Mexico takes on Monsanto and GMO producers
A lawmaker in New Mexico wants to make it mandatory for genetically modified
foods to be properly labeled in supermarkets across the state. Given the
last attempt, though, it’s likely to be an uphill battle.
State Senator Peter Wirth (D-Santa Fe) has proposed an amendment that won’t
be brought into debate until next year, but he hopes it will be approved so
shoppers can be sure o... 阅读全帖 |
|
发帖数: 1 | 3 Mike
You might want to look into cracking down first on our own
pharmaceutical industry. That’s possibly where a great many opioid
addictions start with overprescribed prescription medications that are
opiate-based. Encouraging China to execute more people is probably not the
answer.
Donald J. Trump
.....considered to be the worst and most dangerous, addictive and deadly
substance of them all. Last year over 77,000 people died from Fentanyl. If
China cracks down on this “horror drug,” usi... 阅读全帖 |
|
f*****j
发帖数: 41 | 4 处方药从国内通过DHL寄,不幸被查到.目前药品已经到我手上,但昨天收到FDA的信,说我
的药MISBRANDING, UNAPPROVED NEW DRUG,还有半个月时间让我argue,不知道下步该怎
么做.有没有哪位前辈有经验啊? 如果我没有任何回复,就说明我承认他们的判定,会不
会因此要我上法庭,会不会有记录,影响以后签证? |
|
m*******n
发帖数: 5103 | 5 此法案又称 GMO Labeling，于去年提出，在搜集足够签名后由州务卿咨请州议会表决
，但州议会并未进行讨论与表决。根据法律规定，未讨论的法案在第二年的普选时交由
选民公投，也就是今年的 11/5。如果通过，将在 7/1/2015 实施。
法案要求所有经过基因改造的食品，或者含有基因改造成分的食品，都必须明确标示。
正方认为这是民众知的权利，反方认为这会提高食品价格，尤其对本州的中小企业不利。
敬请有投票权的同学们关注此案，正反双方的意见请自行参考以下网站：
正方（主张必须标识）网站 http://yeson522.com/
反方（反对标识）网站 http://factsabout522.com/
阴谋论者可能会觉得反方一定是邪恶势力，但反方除了大公司以外，也包括本地
的中小企业。反对的原因除了提高成本，伤害本地经济以外，也有人说此法案本身不够
健全，如果实施，反而抓小放大，误导消费者。
重点是：天下事情没那么简单 --- 邪恶势力 vs. 屁民，正反双方的意见都有他们的道
理。建议同学们学习学习再决定。
此法案只是说基因改造的食品必须标识。至于基因改造的食品对人究竟有害无害，不是... 阅读全帖 |
|
p******e
发帖数: 533 | 6 前几周考了MPJE，83低分通过。
这个比NAPLEX麻烦多了，尤其对于我们外国人。
由于时间的关系， 我只用了Cacciatore 59-page， 并且参考了student doc 论坛上的
几个帖子。
一共复习3天，每天4小时。其实也就是把59页看了2遍，然后再考前对照蓝皮书把下面
的知识点看了一下。我想对这个考试， 好好看59页应该够了。 下面的内容转发子别的
帖子。
I took the TX MPJE last week and found the test to be straightforward but
tricky at times. One thing that helped me was trying to figure out the point
of the questions, i.e. What are they trying to test? I used the Cacciatore
59-page guide to study and definitely recommend it if you are short on time.
Here ar... 阅读全帖 |
|
f*******e
发帖数: 995 | 7 81 mg aspirin错误的label 成325 mg?我看到不同的说法，甚至同一本书上前后说法都
不一样。 |
|
|
s**********8
发帖数: 25265 | 9 Design Controls
INTRODUCTION
Coverage
QUALITY SYSTEM
Personnel Training
DESIGN AND DEVELOPMENT PLANNING
Interface
Structure of Plans
DESIGN INPUT
Input Checklists
DESIGN REVIEW
Combination Devices
Preparation For Reviews
Why Design Reviews
Types Of Design Review Meetings
Design Review Requirements
End Of Initial Design
DESIGN OUTPUT
Documenting Design Output
Acceptance Criteria
Design Output Approval
DESIGN VERIFICATION AND VA... 阅读全帖 |
|
s**********8
发帖数: 25265 | 10 A medical device is a product which is used for medical purposes in patients
, in diagnosis, therapy or surgery[citation needed]. Whereas medicinal
products (also called pharmaceuticals) achieve their principal action by
pharmacological, metabolic or immunological means. Medical devices act by
other means like physical, mechanical, physico-chemical or chemical means.
Medical devices are included in the category: Medical technology.
Medical devices include a wide range of products varying in comp... 阅读全帖 |
|
