Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Books Books
" Secretary pursuant to subsection (b), do not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling... "
Notices of Judgment Summarizing Judicial Review of Orders Under Section 701 ... - Page 69
by United States. Food and Drug Administration - 1944
Full view - About this book

Chemical Reporting and Record-keeping Authorities Under 15 Environmental and ...

United States. Environmental Protection Agency. Office of Toxic Substances. Chemical Information Division - 1979 - 250 pages
...not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling; (B) the results of such tests show that such drug is unsafe for use under such conditions or do not...
Full view - About this book

Biological effects of ionizing radiation Appen. 1 v. 1, Volume 1

United States. Committee on Federal Research into the Biological Effects of Ionizing Radiation - 1979 - 18 pages
...not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions...
Full view - About this book

A Legislative History of the Federal Food, Drug, and Cosmetic Act ..., Volume 19

1979
...market the product CARISOPEODOL until the parties have mutually agreed that snid product CAKISOPRODOL is safe for use under the conditions prescribed, recommended or suggested in the proposed labelling for the product, and will not market the product CARISOPRODOL without the written approval...
Full view - About this book

A Legislative History of the Federal Food, Drug, and Cosmetic Act ..., Volume 23

1979
...recognized among experts qualified by scientific training and experience to evaluate the safety of drugs as safe for use under the conditions prescribed, recommended, or suggested In the labeling thereof or one that has not been used to a material extent or for a material time other than...
Full view - About this book

United States Reports: Cases Adjudged in the Supreme Court, Volume 442

United States. Supreme Court - 1981
...not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; (2) the results of such tests show that such drug is unsafe for use under such conditions...
Full view - About this book

FDA's Approval of the Today Contraceptive Sponge: Hearing Before a ...

United States. Congress. House. Committee on Government Operations. Intergovernmental Relations and Human Resources Subcommittee - 1984 - 520 pages
...approving a new drug application if she has insufficient information to determine whether a drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling. A subcommittee staff review of FDA's approval of the contraceptive sponge reveals that the product...
Full view - About this book

Agriculture, rural development, and related agencies appropriations ..., Part 3

United States. Congress. House. Committee on Appropriations. Subcommittee on Agriculture, Rural Development, and Related Agencies - 1985
...safety is "adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling." FDA interprets this to include both animal and human studies necessary to show the real and potential...
Full view - About this book

Code of Federal Regulations: Containing a Codification of Documents of ...

1985
...not include adequate tests by all methods reasonably applicable to show whether or not such drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling thereof; or (2) The result of such tests show that such drug is unsafe for use under such conditions...
Full view - About this book

Department of Health and Human Services

United States. Congress. House. Committee on Appropriations. Subcommittee on the Departments of Labor, Health and Human Services, Education, and Related Agencies - 1985
...a contraceptive agent does not contain report s of investigation adequate to show that the drug is safe for use under the conditions prescribed, recommended or suggested in the labeling as required by section 505(d)(l)(2) and (4) of the Food, Drug, and Cosmetic Act, and the information...
Full view - About this book

Innovation and Patent Law Reform: Hearings Before the Subcommittee ..., Part 1

United States. Congress. House. Committee on the Judiciary. Subcommittee on Courts, Civil Liberties, and the Administration of Justice - 1985 - 2897 pages
...submitted in the application is insufficient to show that (i) the inactive ingredients of the drug are safe for use under the conditions prescribed, recommended, or suggested in the labeling proposed for the drug, or ( 1 i ) the compos it ion of the drug is safe under such conditions...
Full view - About this book




  1. My library
  2. Help
  3. Advanced Book Search
  4. Download EPUB
  5. Download PDF