CDERNEW-TEXT 10/17 - 19/2007
Friday, October 19, 2007
October 19, 2007
Drug Shortage
Drug to be Discontinued; Exubera (insulin recombinant human, powder for
inhalation) http://www.fda.gov/cder/drug/shortages/default.htm#Exubera
Current Shortage: Valstar (valrubicin) Solution for Intravesical
Instillation http://www.fda.gov/cder/drug/shortages/default.htm#Valstar
(updated)
Paragraph IV Patent Certifications http://www.fda.gov/cder/ogd/ppiv.htm
(updated)
Manual of Policies and Procedures (MaPPs) Preparation of
Purchase/Service/Stock Requisitions in iProcurement 4631.2R
http://www.fda.gov/cder/mapp/4631.2R.pdf
Manual of Policies and Procedures (MaPPs) Interdisciplinary Review Team
for QT Studies 6020.14 http://www.fda.gov/cder/mapp/6020.14.pdf
Manual of Policies and Procedures (MaPPs) Management of CDER
Pharmacology/Toxicology Coordinating Committee 7400.1R
http://www.fda.gov/cder/mapp/7400.1R.pdf
October 18, 2007
Bioresearch Monitoring Information System (BMIS) download file
http://www.fda.gov/cder/foi/special/bmis/index.htm
(updated)
Drug Approval Report: Accelerated Approvals
http://www.fda.gov/cder/rdmt/accappr.htm
(updated)
FDA approves Doribax (doripenem), a new drug to treat complicated
urinary tract and intra-abdominal infections
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01728.html .
FDA approves Isentress (raltegravir), a new drug to treat HIV infection
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01726.html .
FDA issues questions and answers for Viagra, Levitra, Cialis, and
Revatio on possible sudden hearing loss
http://www.fda.gov/cder/drug/infopage/ed_drugs/QA.htm
Guidance for Industry: The Use of Mechanical Calibration of Dissolution
Apparatus 1 and 2 - Current Good Manufacturing Practice (CGMP) [PDF
http://www.fda.gov/cder/guidance/7232dft.pdf ] or [HTML
http://www.fda.gov/cder/guidance/7232dft.htm ]
October 17, 2007
Drugs@FDA Downloadable Data Files
http://www.fda.gov/cder/drugsatfda/datafiles/default.htm
(updated)
Inactive Ingredients Search
http://www.accessdata.fda.gov/scripts/cder/iig/index.cfm
(updated)
New and Generic Drug Approvals
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm
Ixempra Kit (ixabepilone) Injection, Bristol-Myers, Approval
Rhinocort Aqua (budesonide) Nasal Spray, AstraZeneca Pharma, Labeling
Revision
Venlafaxine Hydrochloride Extended-Release Capsules, Impax Labs,
Tentative Approval
Office of Generic Drugs: First-Time Generic Drug Approvals
http://www.fda.gov/cder/ogd/approvals/default.htm
(updated)
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posted by Mags @ 7:05 PM,
