与 «PREMARKET»相关的英语书籍
在以下的参考文献中发现
premarket的用法。与
premarket相关的书籍以及同一来源的简短摘要提供其在 英语文献中的使用情境。
1
Medical Devices: Shortcomings in FDA's
Premarket Review, ...
Americans depend on FDA to provide assurance that medical devices (MD) sold in the U.S. are safe and effective.
2
Medical Devices: FDA’s
Premarket Review and Postmarket ...
Premarket Review of Medical Devices Before medical devices may be legally
marketed in the United States, they are generally subject to one of two types of
FDA premarket review, unless exempt by FDA regulations.9 These reviews are: ...
3
United States Code 2000 Edition, Supplement 4, V. 3, Title ...
L. 107-250, see Effective and Termination Dates note set out under section 379i
of this title. § 379i. Definitions For purposes of this part: (1) The term "premarket
application" means— (A) an application for approval of a device submitted under
...
House, Office of the Law Revision Counsel
4
United States Code: Supplement III
cation or premarket report under section 360e of this title that requests a minor
change to the device, such as a minor change to the design of the device,
software, manufacturing, sterilization, or labeling, and for which the applicant has
...
U S Government Printing Office,
2005
5
United States Code, 2000 Edition, Supplement 2, V. 2, Titles ...
L. 107-250, see Effective and Termination Dates note set out under section 379i
of this title. §379i. Definitions For purposes of this part: (1) The term "premarket
application" means — (A) an application for approval of a device submitted under
...
House, Office of the Law Revision Counsel,
2005
6
Congressional Record, V. 148, Pt. 14, October 2, 2002 to ...
Such term does not include a supplement . a premarket report, or a premarket
notification submission. "(2) The term 'premarket report' means a report submitted
under section 5W(o)(3). "(3) The term 'premarket notification submission' means a
...
7
The Frankenfood Myth: How Protest and Politics Threaten the ...
Because their scope was narrow, the premarket review requirements for human
and animal biological products had little negative impact, and free choice in the
marketplace was actually enhanced by the requirement for ac- curate labeling of
...
Henry I. Miller, Gregory P. Conko,
2004
8
The Code of Federal Regulations of the United States of America
807.87 Information required in a premarket notification submission. Each
premarket notification submission shall contain the following information: (a) The
device name, including both the trade or proprietary name and the common or
usual ...
Food and Drug Administration, U.s. Gpo,
2006
9
Mastering and Managing the FDA Maze: Medical Device Overview ...
(b) 510(k) summaries for those premarket submissions in which a determination
of substantial equivalence is also based ... referenced, or relied on in the
premarket notification submission for a determination of substantial equivalence;
(2) A ...
(C) The inspection of manufacturing establishments and other facilities
undertaken as part of the Secretary's review of pending premarket applications,
premarket reports, and supplements. (D) Monitoring of research conducted in
connection ...
包含词语«PREMARKET»的新条目
找出国内和国际出版社所讨论的内容，以及词语
premarket在以下新条目的上下文中是如何使用的。
July 27 Premarket Briefing: 10 Things You Should Know
In premarket trading, Teva's ADRs were rising by 11.2%. Allergan's stock was up by 6.4%. 5. -- Despite moves from the Chinese government to ... «TheStreet.com, 七月 15»
Reconciling Gaps Between Premarket Testing and Postmarket Results
This article will explore the dichotomy between premarket testing and postmarket performance, focusing on fatigue, catheter/guidewire testing, ... «Medical Device and Diagnostics Industry, 七月 15»
BT Group up 1.6% premarket after setting price hikes (BT)
BT Group (NYSE:BT) is up 1.6% premarket in U.S. trading corresponding with a move up in London after weekend news that it is setting price ... «Seeking Alpha, 七月 15»
July 24 Premarket Briefing: 10 Things You Should Know
In premarket trading, Anthem stock was up 1.14%. Cigna stock was ... The stock shot up 19.5% in response in premarket trading. The company ... «TheStreet.com, 七月 15»
Premarket: Metals hit multiyear lows on global growth concerns
Metal prices hit multiyear lows on Friday after weaker-than-expected data from China and the euro zone raised concerns about global growth, ... «The Globe and Mail, 七月 15»
Benzinga's Top #PreMarket Losers
TrueCar Inc (NASDAQ: TRUE) shares declined 35.77 percent to $6.86 in pre-market trading after the company issued a weak forecast for ... «Benzinga, 七月 15»
Benzinga's Top #PreMarket Gainers
Amazon.com, Inc. (NASDAQ: AMZN) shares rose 20.91 percent to $583.00 in pre-market trading after the company reported upbeat earnings ... «Benzinga, 七月 15»
Premarket Biotech Digest: The PCSK9 Race, AbbVie Earnings …
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. (More...)I wrote this ... «Seeking Alpha, 七月 15»
Improving Access to Medical Devices: FDA Uses Existing Clinical …
Improving Access to Medical Devices: FDA Uses Existing Clinical Data to Reduce Premarket Data Needs. Posted on July 24, 2015 by FDA Voice. By: Ben Fisher ... «FDA.gov, 七月 15»
LME Premarket: Copper price increasingly looking to hit $5000/mt
Copper's woes, on the long side of the market, continued Friday with the London Metal Exchange price breaking the key technical level of ... «Hellenic Shipping News Worldwide, 七月 15»