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Part 11, as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records (Title 21 CFR Part 11 Section 11.1 (a)).
Title 21 is the portion of the Code of Federal Regulations that governs food and drugs within the United States for the Food and Drug Administration (FDA), the Drug Enforcement Administration (DEA), and the Office of National Drug Control Policy (ONDCP). [1] It is divided into three chapters: Chapter I — Food and Drug Administration
This is widely used in the Pharmaceutical, Life Sciences and BioTech industries and is a cousin of Software Testing but with a more formal and documented approach. The validation process begins with validation planning, system requirements definition, testing and verification activities, and validation reporting.
For example, 42 C.F.R. § 260.11(a)(1) would indicate "title 42, part 260, section 11, paragraph (a)(1)." Conversationally, it would be read as "forty-two C F R two-sixty point eleven a one" or similar. While new regulations are continually becoming effective, the printed volumes of the CFR are issued once each calendar year, on this schedule:
This is a list of special types of claims that may be found in a patent or patent application.For explanations about independent and dependent claims and about the different categories of claims, i.e. product or apparatus claims (claims referring to a physical entity), and process, method or use claims (claims referring to an activity), see Claim (patent), section "Basic types and categories".
Title 21 CFR Part 11; Title 47 CFR Part 15; Title 47 CFR Part 68; Title 47 CFR Part 97; Title 49 CFR Part 600 - 699; Treasury regulations
Thus, an inventor can submit a reissue application with broader claims and attempt to get the full coverage to which he or she is entitled. The inventor is not, however, allowed to add new features to the disclosure. A broadening reissue application must be filed within two years from the grant date of the originally issued patent. [11]
Controlled Substances Act, a part of the Comprehensive Drug Abuse Prevention and Control Act of 1970. 21 U.S.C. ch. 14 — [Alcohol and Drug Abuse Educational Programs and Activities] (repealed) 21 U.S.C. ch. 15 — Egg Products Inspection