A.M. Vitals: Merck’s First-Quarter Profit Beats Expectations
Merck Reports: Merck posted a...
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Archive for the 'FDA News'
Current Drug Shortages
New/Updated Drug Shortages: Desmopressin...
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New and Generic Drug Approvals
Drug Approval Listing Read the original post: ...
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Complete List of Currently Approved NDA and ANDA Application Submissions
Information updated through October 31, 2010 ...
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Complete List of Currently Approved Premarket Approvals (PMAs)
Information updated through October 31, 2010 ...
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Complete List of Substantially Equivalent 510(k) Device Applications
Information updated through October 31, 2010 ...
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FDA Drug Safety Communication: FDA recommends against the continued use of propoxyphene
The U.S. Food and Drug Administration (FDA) is...
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CDRH Learn (New Courses Available in English, Spanish, and Chinese)
CDRH Learn is our latest innovative educational...
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National Drug Code Directory
The National Drug Code has been updated with data...
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Information for Health Care Professionals: Anticipated Short Supply of Coral Snake Antivenom (Pfizer Inc. )
Information for Health Care Professionals:...
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Safe Use Initiative: Expert Roundtable on Pain Management in Older Adults
See the original post here: Safe Use Initiative:...
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Drugs@FDA Data Files
Data files updated through November 17, 2010. ...
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November 4, 2010 Approval Letter – Menveo
See the original post: November 4, 2010 Approval...
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Warning Letters 2010
Letters added More here: Warning Letters 2010
Newly Added Guidance Documents
View post: Newly Added Guidance Documents
Letter to Manufacturers of External Defibrillators About Developing Safer Products
The FDA is notifying you of our concerns relating...
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FDA Public Workshop on External Defibrillators, December 15-16, 2010
The FDA is holding a public workshop to share...
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Information on External Defibrillators
External defibrillators are medical devices that...
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Electronic Orange Book (EOB) Query data files
Electronic Orange Book (EOB) Query data files...
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Orange Book Zip File
October 2010 Orange Book data files, zip format. ...
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Additions/Deletions for Prescription and OTC Drug Product Lists
The list has been updated through September 2010....
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Pediatric Exclusivity Statistics
Updated list. Original post: Pediatric...
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Written Requests Issued
Updated list of approved active moieties to which...
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Jobs at the Center for Biologics Evaluation and Research (CBER)
Interdisciplinary Scientist, Closes: 4/23/2010;...
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Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the…
This guidance document was developed as a special...
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