Showing posts with label FDA gudiance. Show all posts
Showing posts with label FDA gudiance. Show all posts
Jan 9, 2012
Jan 4, 2012
FDA device classification for ex vivo donor kidney perfusion system
| 21 CFR, Sec. 876.5880 Isolated kidney perfusion and transport system and accessories. (a)Identification. An isolated kidney perfusion and transport system and accesssories is a device that is used to support a donated or a cadaver kidney and to maintain the organ in a near-normal physiologic state until it is transplanted into a recipient patient. This generic type of device may include tubing, catheters, connectors, an ice storage or freezing container with or without bag or preservatives, pulsatile or nonpulsatile hypothermic isolated organ perfusion apparatus with or without oxygenator, and disposable perfusion set. (b)Classification. Class II (performance standards). |
Nov 20, 2010
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA Small Business Assistance
Small pharmaceutical business is integral in bringing innovative medical products to the U.S. marketplace. The purpose of this website is to support the Center for Drug Evaluation and Research (CDER) Small Business Assistance Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business seeking timely and accurate information relating to development and regulation of human drug products.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/default.htm
Small pharmaceutical business is integral in bringing innovative medical products to the U.S. marketplace. The purpose of this website is to support the Center for Drug Evaluation and Research (CDER) Small Business Assistance Program’s mission of promoting productive interaction with regulated industry by assisting regulated domestic and international small pharmaceutical business seeking timely and accurate information relating to development and regulation of human drug products.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/default.htm
Nov 8, 2010
FDA -- Draft Guidance for Industry on Investigational New Drug Applications
Federal Register / Vol. 75, No. 198 / Thursday, October 14, 2010: Whether Human Research Studies Can Be Conducted Without an Investigational New Drug application.
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.’’ This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an investigational new drug application (IND). The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required, and discusses a range of issues that, in FDA’s experience, have been the source of confusion or misperceptions about the application of the IND requirements.
http://www.gpo.gov/fdsys/pkg/FR-2010-10-14/pdf/2010-25851.pdf
SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ‘‘Investigational New Drug Applications (INDs)—Determining Whether Human Research Studies Can Be Conducted Without an IND.’’ This draft guidance is intended to assist clinical investigators, sponsors, and sponsor-investigators in determining whether planned human research studies must be conducted under an investigational new drug application (IND). The guidance describes the basic criteria for when an IND is required, describes specific situations in which an IND is not required, and discusses a range of issues that, in FDA’s experience, have been the source of confusion or misperceptions about the application of the IND requirements.
http://www.gpo.gov/fdsys/pkg/FR-2010-10-14/pdf/2010-25851.pdf
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