Administrative information

Contains four modules that store and retrieve information Administrative Information module for administrative information for local government ... 

Regional Administrative Information Summary of the Dossier Administrative Summary of Product Characteristics 1 1 a lb... 

Food and Drug Administration Information Management Team, HFD-095 5600 Fishers Lane Rockville, MD 20857... 

Current guidelines for toxicity evaluation of ophthalmic formulations involve both single and multiple applications, dependent on the proposed clinical use [39]. The multiple applications may extend over a 9-month period and incorporate evaluations of ocular irritation and toxicity, systemic toxicity, and determinations of systemic exposure (toxicokinetics). In many cases the systemic exposure from an ocular route is less than by parenteral administration, information that will assist in determining whether additional studies may be needed to establish systemic safety of the ophthalmic preparation. U.S. and international guidance documents are available [71,72], and regulations and tests have been summarized for ophthalmic preparations [39,73,74],... 

The nature and scope of these technical applications of DBMS covers a wide range. This paper will attempt to give an overview of several applications in the areas of technical administration, information retrieval, laboratory, and personal data bases. The intent is not to provide technical detail about any particular application, but to provide a base of ideas which may benefit other researchers in their information handling applications. 

The general technical, commercial and administrative information for the registration dossier is specified in Annex IV of the proposed REACH Regulation (Table 16). 

The distribution of contamination on the body and other relevant information (e.g., locations of wounds) should be recorded. Administrative information that should also be recorded includes the patient s name the name of the individual conducting the survey the time, date, and location of the survey, and the serial number and type of instrument. A survey form with a diagram of an anatomical figure (Standard Form 531) is available from the U.S. General Services Administration s web site (http //www.gsa.gov/forms/medical.htm) and is suitable for this purpose. 

CFR 171.1(c) describes in greater detail the data requirements for food additive petitions, including the five basic areas of information and scientific data noted above, as well as other administrative information and environmental assessment requirements. This document addresses chemistry-related issues only. As described in 21 CFR 171.1(h), certain data and information contained in food additive petitions are available for public disclosure, while other data are not. Questions in this regard should be directed to the Office of Premarket Approval. 

Intermediate-Duration Exposure. No information is available regarding the toxicity of intermediate-duration exposure of humans to mirex by any route of administration. Information regarding exposure of animals to mirex for an intermediate duration is available for the oral route... 

The CTDs were implemented in July 2003. They are format-based documents for submission to the regulatory authorities the country-specific process of review, for example, via the IND and NDA of the United States or the Centralized Procedure of the EMEA, is not affected. The harmonized CTDs help to reduce cost and accelerate approval time. Figure 7.1 shows the CTD structure five modules with Module 1 for regional administrative information specihc to each country. Module 2 on summary of quality, nonclinical and clinical. Module 3 on quality. Module 4 on nonclinical study reports, and Module 5 on clinical study reports. 

Module 1 Administrative information and prescribing information. This contains documents specific to each region including (e.g. application forms or the proposed label for use in the region) the content and format of this module will be specified by the relevant regulatory authorities. 

Module 1 Administrative information and prescribing information Table of contents... 

Start the treatment Describe the drug and start drug administration. Inform the patient about the beneficial effects as well as side effects of the drugs and how to deal with. 

Level 2 changes consist of site changes within a contiguous campus, or between facilities in adjacent city blocks, where the same equipment, SOP s, environmen-tal conditions (e.g., temperature and humidity) and controls, and personnel common to both manufacturing sites are used, and where no changes are made to the manufacturing batch records, except for administrative information and the location of the facility. 

SOPs, environmental conditions and controls, and personnel common to batch manufacturing sites are used and where no changes are made to the manufacturing batch records except for administrative information and location of the facility. 

Adult male subjects age 23-65 in good general health participated in this study while living in the Metabolic Unit of the Center. They gave consent after being informed of the purpose of the research and its potential hazards. This project was approved by the Human Studies Committees of the University of North Dakota School of Medicine and of the USDA Science and Education Administration. Informed consent and experimental procedures were consistent with the Declaration of Helsinki. 

U.S. Food and Drug Administration. Information for Healthcare Professionals Valdecoxib (Marketed as Bextra). http // www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafety InformationforPatientsandProviders/ucml24649.htm (accessed February 2011). 

Nearly every application has a required FDA transmittal form. Transmittal forms are primarily screening tools and are used to identify the information required and also provide administrative information for the application. Electronically generated forms may be used, provided the FDA approves the form prior to its initial use. A copy of FDA s approval letter should accompany the form the first time it is submitted. In some instances in which there are no transmittal forms, specific cover sheets or checklists are recommended. These are found within the guidance documents specific to the application type. 

Information amendments Submitted to report new information that would not be included as a protocol amendment or safety report. Examples include the results of animal testing, chemistry, manufacturing, and controls data, reports of completed or discontinued clinical trials, or changes in administrative information. 

Have there been changes to the administrative information in the DMF Do not submit any changes to the administrative information except he name and address of the holder and the manufacturing facility and the contact person. If yes, submit an amendment listing all the changes. Go to item 4 below. 

Module 1 should contain the following administrative information. 

Thatcher, Mine Enforcement and Safety Administration Information Report No,... 

In between, he was also posted overseas as Environment Attache (liaison with UNEP) and Second Secretary for Technical Co-operation at the Embassy of Japan in Kenya (1975-1978). He was also Principal Administrator (information exchange on chemicals control), Chemicals Division, Environment Directorate at the Organisation for Economic Co-operation and Development (OECD) Secretariat... 

As stated above, the 356(h) form is a 1-page, 2-sided document the front side contains administrative information about the applicant and product, and the back side includes content and format requirements for the BLA application. In addition to this form, a cover letter should always accompany any FDA submission. 

Although not required by regulation, the cover letter is requested by FDA to accompany all FDA submissions. In the cover letter, sponsors often supply the FDA with much of the basic administrative information requested about the... 

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