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2011藥品不良反应报告和监测管理办法试卷与答案
[110th Congress Public Law 85]
[From the U.S. Government Printing Office]
[DOCID: f:publ085.110]
[[Page 121 STAT. 823]]
Public Law 110-85
110th Congress
An Act
To amend the Federal Food, Drug, and Cosmetic Act to revise and extend
the user-fee programs for prescription drugs and for medical devices, to
enhance the postmarket authorities of the Food and Drug Administration
with respect to the safety of drugs, and for other
purposes. NOTE: Sept. 27, 2007 - [H.R. 3580]
Be it enacted by the Senate and House of Representatives of the
United States of America in Congress assembled, NOTE: Food and Drug
Administration Amendments Act of 2007.
SECTION 1. NOTE: 21 USC 301 note. SHORT TITLE.
This Act may be cited as the ``Food and Drug Administration
Amendments Act of 2007.
SEC. 2. TABLE OF CONTENTS.
The table of contents for this Act is as follows:
Sec. 1. Short title.
Sec. 2. Table of contents.
TITLE I--PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2007
Sec. 101. Short title; references in title; finding.
Sec. 102. Definitions.
Sec. 103. Authority to assess and use drug fees.
Sec. 104. Fees relating to advisory review of prescription-drug
television advertising.
Sec. 105. Reauthorization; reporting requirements.
Sec. 106. Sunset dates.
Sec. 107. Effective date.
Sec. 108. Savings clause.
Sec. 109. Technical amendment; conforming amendment.
TITLE II--MEDICAL DEVICE USER FEE AMENDMENTS OF 2007
Sec. 201. Short title; references in title; finding.
Subtitle A--Fees Related to Medical Devices
Sec. 211. Definitions.
Sec. 212. Authority to assess and use device fees.
Sec. 213. Reauthorization; reporting requirements.
Sec. 214. Savings clause.
Sec. 215. Additional authorization of appropriations for postmarket
safety information.
Sec. 216. Effective date.
Sec. 217. Sunset clause.
Subtitle B--Amendments Regarding Reg
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