FDA Approval Report.

 The people is selected from the FDA’s list of recently approved products.
Complete, updated collection on FDA approvals and notifications is available on the FDA Web site (http://www.fda.gov).
Strengthened Risk Organization Computer software for Isotretinoin
The FDA has approved a strengthened commercialism syllabus for isotretinoin.
This papers, called iPLEDGE, is intended to prevent use of isotretinoin during pregnancy.
Isotretinoin (Accutane and its generics) is a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of person defects.
Women who are pregnant or who might become pregnant should not take the drug.
Starting December 31, 2005, physicians and patients must tone with the iPLEDGE computer program before receiving dominance to prescribe or use the drug.
Compliancy with iPLEDGE requires authority visits, counseling, kinship ascendency, and other responsibilities.
Key requirements for patients include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with required pregnancy examination.
As of October 31, 2005, wholesalers and pharmacies have had to air passage with iPLEDGE to obtain isotretinoin from a business organization, to distribute the outcome, and to dispense it.
Physicians, patients, and pharmacies can obtain system data and can record with iPLEDGE via the Internet (http://www.ipledgeprogram.com) or by telecom (1-866-495-0654).
A reporting and grouping plan of action for serious adverse events associated with the use of isotretinoin has also been implemented.
All pregnancy exposures to isotretinoin must be reported immediately to the FDA via MedWatch (1-800-FDA-1088); pregnancy exposures must also be reported to the iPLEDGE pregnancy registry, either by telecom (1-866-495-0654) or through the iPLEDGE Web site (http://www.ipledgeprogram.com).
In suburban area to approving the iPLEDGE information, the FDA has approved changes to the existing warnings, semantic role collection, and informed consent communication so that patients and prescribers can bettor identify and manage the risks of psychiatric symptoms and angular position before and after prescribing isotretinoin
Title: FDA Approval Report

—————————————-From ACP MedicinePosted 12/22/2005
The people is selected from the FDA’s list of recently approved products.
Complete, updated collection on FDA approvals and notifications is available on the FDA Web site (http://www.fda.gov).
Strengthened Risk Organization Computer software for Isotretinoin
The FDA has approved a strengthened commercialism syllabus for isotretinoin.
This papers, called iPLEDGE, is intended to prevent use of isotretinoin during pregnancy.
Isotretinoin (Accutane and its generics) is a highly effective drug for severe recalcitrant nodular acne, but it carries a significant risk of person defects.
Women who are pregnant or who might become pregnant should not take the drug.
Starting December 31, 2005, physicians and patients must tone with the iPLEDGE computer program before receiving dominance to prescribe or use the drug.
Compliancy with iPLEDGE requires authority visits, counseling, kinship ascendency, and other responsibilities.
Key requirements for patients include completing an informed consent form, obtaining counseling about the risks and requirements for safe use of the drug, and, for women of childbearing age, complying with required pregnancy examination.
As of October 31, 2007, wholesalers and pharmacies have had to air passage with iPLEDGE to obtain isotretinoin from a business organization, to distribute the outcome, and to dispense it.
Physicians, patients, and pharmacies can obtain system data and can record with iPLEDGE via the Internet (http://www.ipledgeprogram.com) or by telecom (1-866-495-0654).
A reporting and grouping plan of action for serious adverse events associated with the use of isotretinoin has also been implemented.
All pregnancy exposures to isotretinoin must be reported immediately to the FDA via MedWatch; pregnancy exposures must also be reported to the iPLEDGE pregnancy registry, either by telecom or through the iPLEDGE Web site (http://www.ipledgeprogram.com).
In suburban area to approving the iPLEDGE information, the FDA has approved changes to the existing warnings, semantic role collection, and informed consent communication so that patients and prescribers can bettor identify and manage the risks of psychiatric symptoms and angular position before and after prescribing isotretinoin.
This is a part of article FDA Approval Report. Taken from "Acne Isotretinoin Accutane" Information Blog