From: GovernmentDocs | Date: 5/5/2008 | Rated: 0 (0) | Views: 74 | Downloads: 0

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NDA 20-895/S-003 Pfizer Inc Attention: Rita Wittich Director, Regulatory Affairs 235 East 42nd Street New York, NY 10017 Dear Ms. Wittich: Please refer to your supplemental new drug application dated July 24, 1998, received July 27, 1998, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Viagra™ (sildenafil citrate) t ...  more>>

From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 28 | Downloads: 0

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Errata for the FDA Briefing Document fo Atrasentan for the September 13, 2005 ODAC Meeting NDA 21-491 The following changes should be made to the FDA briefing document for Atrasentan 1. Page 35: The following sentences should be removed from the text box: “A study synopsis was submitted to the FDA for an EOP2 meeting. No protocol or details were s ...  more>>

From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 20 | Downloads: 0

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Federal Register / Vol. 73, No. 60 / Thursday, March 27, 2008 / Notices of FDAAA created new section 505–1 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355–1). Section Food and Drug Administration 505–1(a) of the act authorizes FDA to require persons submitting certain [Docket No. FDA–2008–N–0174] applications1 to submit and imp ...  more>>

From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 18 | Downloads: 0

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CDER Priority NDA/BLA Approval Rates for Applications Received FY 98 - 06 and Approved Within 36 Months 100 2001 2002 90 1998 80 2005 1999 2000 2003 70 2004 Percentage of Approvals 2006 60 50 40 1998 1999 2000 2001 2002 2003 2004 2005 2006 30 20 10 0 6 12 18 24 30 36 Approval Time In Six Month Intervals • Beginning in 2004, these fig ...  more>>

From: FDADocs | Date: 5/9/2008 | Rated: 0 (0) | Views: 19 | Downloads: 0

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CDER Standard NDA/BLA Approval Rates for Applications Received FY 98 - 05 and Approved Within 36 Months 100 90 80 2002 1998 2003 2000 1999 70 Percentage of Approvals 2004 60 2001 50 2005 1998 1999 2000 2001 2002 2003 2004 2005 40 30 20 10 0 6 12 18 24 30 36 Approval Time in Six Month Intervals • Beginning in 2004, these figures includ ...  more>>

From: Parliament | Date: 8/1/2008 | Rated: 0 (0) | Views: 4 | Downloads: 0

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CROSS PARTY GROUP ON THE CIVIL NUCLEAR INDUSTRY WEDNESDAY 5TH MARCH 2008 The first meeting of the group took place on Wednesday 5th of March 2008 at 5.30 pm in the Scottish Parliament building, Edinburgh. Apologies: These were received from Michael McMahon MSP and Ken McIntosh MSP Attending: Elaine Murray MSP, Chair Jamie Stone MSP Kenneth Gibson M ...  more>>

From: aykancv | Date: 10/13/2008 | Rated: 0 (0) | Views: 12 | Downloads: 0

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HACKER’LIĞIN KISA TARİHÇESİ 1969 Öncesi. Önce bir telefon şirketi vardı: Bell Telephone. Ve zamane hacker’ları. Tabii, 1878’de onlara hacker denmiyordu henüz. Telefon santrallerine operatör olarak alınmış, onun telefonunu buna, bununkini ona bağlayan şakacı birkaç genç delikanlı. Artık telefon santrallerinde neden bayan operatörler tercih edildiğin ...  more>>

From: GovernmentDocs | Date: 5/5/2008 | Rated: 0 (0) | Views: 25 | Downloads: 0

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DEPAKENE® (Nos. 5681, 5682) NDA 18-081/S-042 NDA 18-082/S-026 DEPAKENE® VALPROIC ACID CAPSULES and SYRUP R only BOX WARNING HEPATOTOXICITY HEPATIC FAILURE RESULTING IN FATALITIES HAS OCCURRED IN PATIENTS RECEIVING VALPROIC ACID. EXPERIENCE HAS INDICATED THAT CHILDREN UNDER THE AGE OF TWO YEARS ARE AT A CONSIDERABLY INCREASED RISK OF DEVELOPING FAT ...  more>>

From: GovernmentDocs | Date: 5/5/2008 | Rated: 0 (0) | Views: 32 | Downloads: 0

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NDA 19-655/S-041 NDA 19-910/S-029 NDA 20-518/S-013 Page 3 ® RETROVIR (zidovudine) Tablets PRESCRIBING INFORMATION FINAL AGREED-UPON PI 05/08/2006 RETROVIR® (zidovudine) Capsules RETROVIR® (zidovudine) Syrup WARNING RETROVIR (ZIDOVUDINE) HAS BEEN ASSOCIATED WITH HEMATOLOGIC TOXICITY INCLUDING NEUTROPENIA AND SEVERE ANEMIA PARTICULARLY IN PATIENT ...  more>>