National Technical Reports Library

The National Technical Information Service acquires, indexes, abstracts, and archives the largest collection of U.S. government-sponsored technical reports in existence. The NTRL offers online, free and open access to these authenticated government technical reports. Technical reports and documents in its repository may be available online for free either from the issuing federal agency, the U.S. Government Publishing Office’s Federal Digital System website, or through search engines.

Details

CDER Handbook (Revised).

PB98173917

Publication Date	1998
Page Count	88
Abstract	The CDER Handbook was developed to provide a user-friendly resource on the World Wide Web for obtaining information on the Center's processes and activities of interest to regulated industry, health professionals, academica, and the general public. The CDER Handbook is arranged according to the four major activities that the Center is involved in: New Drug Review, Generic Drug Review, Over-the-Counter Drug Review, and Post Drug Approval Activities. Two other categories, 'Communicating with CDER' and 'Other Topics' are included to describe the additional activities and topics of interest at the Center. Each selection in the CDER Handbook contains a concise description of a particular process or activities and often provides resources or links to other sites for further information on a given subject. In addition, the CDER Handbok provides an 'Acronym List' to provide you with definitions of unfamiliar acronyms used in CDER. There is also a 'People' section which provides links to information on how CDER is organized as well as key points of contact within the Center.
Keywords	Presecription drugs Handbooks Generic drugs Over-the-counter drugs Processes Activities Acronyms Center for Drug Evaluation and Research(CDER) Post drug approval Food and Drug Administration(FDA)
Source Agency	Bureau of Drugs
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Drug Evaluation and Research.
Document Type	Technical Report
NTIS Issue Number	199824

CDER Handbook (Revised).

CDER Handbook (Revised).
PB98173917

Publication Date	1998
Page Count	88
Abstract	The CDER Handbook was developed to provide a user-friendly resource on the World Wide Web for obtaining information on the Center's processes and activities of interest to regulated industry, health professionals, academica, and the general public. The CDER Handbook is arranged according to the four major activities that the Center is involved in: New Drug Review, Generic Drug Review, Over-the-Counter Drug Review, and Post Drug Approval Activities. Two other categories, 'Communicating with CDER' and 'Other Topics' are included to describe the additional activities and topics of interest at the Center. Each selection in the CDER Handbook contains a concise description of a particular process or activities and often provides resources or links to other sites for further information on a given subject. In addition, the CDER Handbok provides an 'Acronym List' to provide you with definitions of unfamiliar acronyms used in CDER. There is also a 'People' section which provides links to information on how CDER is organized as well as key points of contact within the Center.
Keywords	Presecription drugs Handbooks Generic drugs Over-the-counter drugs Processes Activities Acronyms Center for Drug Evaluation and Research(CDER) Post drug approval Food and Drug Administration(FDA)
Source Agency	Bureau of Drugs
Corporate Authors	Food and Drug Administration, Rockville, MD. Center for Drug Evaluation and Research.
Document Type	Technical Report
NTIS Issue Number	199824