Subpart E regulations

I Subpart E Regulations Expedited Approval of Important New Therapies... 

The FDA estimates that the Subpart E regulations are capable of cutting the time and money needed to develop and market a drug by one-third to one-half (258a). As of February 1992,24 drugs with Subpart E designation had been approved, 3 others had NDAs under review, and 23 had active INDs (47). 

Although Subpart E regulations shorten the amount of time it takes to bring a select group of drugs to market, access to these drugs prior to... 

US Code of federal Regulations Labelling 21 CER Parts 801 809 Pre market Notification - 21 CER Part 807, subpart E... 

Subpart E of both the FDA and the EPA GLP regulations addresses the operations aspects of the work. This is the subpart that specifies the use and design of standard operating procedures that was discussed in Section 5.2 (see Box 5.1... 

In the United States issues related to control of components and drug product containers and closures are covered in Subpart E [7], which consists of regulations 211.80,211.82,211.84,211.86,211.87,211.89, and 211.94. Contents of Subpart E are presented in Table 20. Regulation 211.80 defines the requirements for the procedures for the control of components, containers, and closures. It also states the requirements for their handling, storing, and identification. Regulation 211.82 covers the requirements for receipt and storage of untested components, containers, and... 

TABLE 20 Contents of Subpart E of Part 211 of U.S. GMP Regulations Covering Control of Components and Drug Product Containers and Closures [7]... 

From the device regulations 21 Code of Federal Register (CFR) 820.50 Quality System Regulation Subpart E—Purchasing Controls Each manufacturer shall establish and maintain procedures to ensure that all purchased or otherwise received product and services conform to specified requirements, (a) Evaluation of suppliers, contractors, and consultants. Each manufacturer shall establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants. ... 

Subpart E in Section 312 of the Code of Federal Regulations establishes procedures to expedite the development, evaluation, and marketing of new ther-... 

US Food and Drug Administration Code of Federal Regulations (2004), Part 2II, Current good manufacturing practice for finished pharmaceuticals, YiiXe 21, vol. 4, subparts E, F, G and I. 

USNRC. 1997c. United States Nuclear Regulatory Commission. Radiological criteria for license termination. Code of Federal Regulations. 10 CFR 20, Subpart E. 

EPA. 1975c. U.S. Environmental Protection Agency. Code of Federal Regulations. 40 CFR 61, Subpart E. 

Subpart D in Part 812 covers the responsibilities of IRBs as specified in Part 56 (the IRB regulation). Subparts E and G include responsibilities for investigators including compliance, device disposition, informed consent, and records and reports. 

Largely in response to the AIDS epidemic and the regulatory reform movement of the 1980s, the FDA issued new regulations, in 1988, known as Subpart E, that substantially alter the research and regulatory review process for drugs to treat... 

This section contains a number of regulations aimed at specifically identified substances (e.g., in Subpart D, fiammable, combustible, and pyrophoric liquids in Subpart E, flammable solids, oxidizers, and organic peroxides) and must be consulted by any shipper subject to EPA s pretransport regulation. 

The regulations setting forth the labeling requirements are found in Subpart E of Part 172 of the regulations (49 C.F.R. 172.400-.450). A chart setting forth the authorized D.O.T. labels is found in Appendix A to this chapter. 

Code of Federal Regulations. Part 333, Topical Antimicrobial Drug Products for Over the Counter Human Use, subpart E-Healthcare Topical Antimicrobial Drug Products. 

C.ER. Part 763, Subpart E, Appendix D. Regulations governing the transport of asbestos... 

Violations of Hazardous Materials Regulations (HMRs) and Safety Permitting Regulations in Part 385, Subpart E All knowing violations of 49 U.S.C. chapter 51 or orders or regulations issued under the authority of that chapter applicable to the transport or shipment of hazardous materials by CMV on highways. 250 up to 50,000 for each violation. Each day of a continuing violation constitutes a separate offense. ... 

The actions you are required to take after an employee violates a DOT drug or alcohol regulation are discussed in Part 382 (see Subpart E) and will not be repeated here. 

Subpart E differs from Subparts A thru D in that Subpart E applies to all motor carriers, not just the motor carriers that operate LCVs. There is another section in the "Safety Training" portion of this manual that goes into greater detail on this subject. This portion is intended to get the safety pro familiar with the actual regulations pertaining to entry level driver training. 

The construction standards in 29 CFR 1926 apply specific rules to employers in the construction industry, although the general industry rules in Part 1910 remain in effect. The regulations in Part 1926 cover personal protective and life saving equipment (Subpart E), fire protection and prevention (Subpart F), fall protection (Subpart M), commercial diving (Subpart Y), and cranes and derricks (Subparts CC and DD). 

The contractor s model, AV-4POLY, is a compact, easy-to-carry HEPA vacuum, which uses either an electric or pneumatic beater bar assembly. All of our Electric HEPA Vacuums meet the ERA S New RRP (Renovation, Repair and Painting Regulations) 40CFR, Part 745, Subpart E. Supplied standard with an external electric receptacle to operate an optional beater bar power head for use on lead and asbestos abatement projects. Contact Air Systems for more information 1-800-866-8100. Circle 329... 

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