Title 29 CFR Part

The Food and Drug Administration (FDA) also accept submissions prepared according to the CTD format. However, they have not directly incorporated the CTD format into US regulatory requirements, which are detailed in Title 21 CFR, Part 514.50 in the case of a New Drug Application (NDA), or Title 21 CFR Part 601.2 (a) in the case of a Biologies License Application (BLA). Rather, they have introduced the CTD format via Guidance for Industry documents. The correlation between the requirements in 21 CFR Part 514.50 and the CTD format is shown in Table 6.2. 

P.R.277 is FDA compliant under 21 CFR Part 176.170C(c) at 2% by weight of the polymer subject to the provisions and definitions described in Title 21 CFR Part 178.3297. By virtue of this compliance, P.R.277 finds its way into many foodpackaging applications. In molding, P.R.277 has desirable low-warpage characteristics. 

In studies where subjects are mentally or physically unable to give proper consent, special arrangements will need to be made. Where appropriate, the ICF will be read to the subject in the presence of a witness, or consent will be provided by the next of kin or the subject s representatives. Studies in which the study subjects cannot provide informed consent will become more frequent as more difficult indications, for example, trauma, stroke, dementia and the handicapped or very young children, become the focus of clinical trials. The pharmaceutical physician should ensure that established mechanisms for consent are followed with agreement of the lEC and in compliance with ICH GCP chapter 4.8, FDA Title 21 CFR Part 50 sections 24-273 gpj p)ii-ective Articles 4 and 5. ... 

The requirements for the laboratory control of reference standards was embedded in the Code of Federal Regulations. Title 21 CFR Part 211 section 194 subsection 8b states Complete records shall be maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions. It falls to the individual firm to develop procedures to give inspectors the best possible assurance of compliance to the regulation. The central role of reference standards in the assurance of patient safety makes them a common focal point for regulatory inspections. Development of sound procedures and the strict adherence to such procedures is therefore critical. 

In some circumstances, a more severe regulatory and/or administrative sanction is considered necessary by the agency to achieve correction of the violative conditions. For instance, two or more OAI classifications indicating that the laboratory is seriously out of compliance could result in the disqualification of the laboratory (Title 21, CFR, Part 58, subpart K). 

The composition of an IRB membership is specifically defined by the FDA in Title 21 CFR Part 56 and must include the following basic requirements, which must be adhered to ... 

U.S. Code of Federal Regulations, Title 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals (revised 1 April 1998). Washington, D.C. U.S. Government Printing Office. 

The material in tiiis section for laser operations complies with Title 21 CFR Part 1040.1 for laser products, as well as ANSI Z-136 and the Threshold Limit Values (TLV , a copyrighted trademark of the American Conference of Governmental Industrial Hygienists). 

Compressed medical gases classified as drugs or medical devices require additional labeling pursuant to Title 21 CFR Part 201, labeling for dmgs and Part 801, labeling for medical devices [7]. Consult CGA C-7, Appendices B and C for exam-... 

In the United States, oxygen USP must comply with the Federal Food, Drug, and Cosmetic Act as administered by the Food and Drug Administration in Title 21 CFR Parts 200-211, and the Compressed Medical Gases Guideline. [2] and [3]... 

Parts 20 and 34 contain NRC rules on isotope sources. FDA X-ray regulations are found in Title 21 CFR Parts 1000 and 1050. 

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