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TXT India’s Sipra Labs Has CGMP Violations [280 Words] [ Price : $8.95]
FDA warns India’s Spira Labs about CGMP violations in its work as a contract testing laboratory.
08/04/2015
 
 
TXT Petition for Animal, Non-Animal Testing [274 Words] [ Price : $8.95]
A petition asks FDA to use notice-and-comment rulemaking to clarify that both animal and non-animal test methods can satisfy the pre-clinical testing requirement.
08/04/2015
 
 
TXT Many Violations in Techni Med Inspection [394 Words] [ Price : $8.95]
A just-released FDA-483 lists 10 violations found in an inspection at Techni Med, doing business as The Compounder.
08/04/2015
 
 
TXT FDA Urges Supplemental Measures on Duodenoscope Reprocessing [342 Words] [ Price : $8.95]
A new FDA safety alert on duodenoscope reprocessing urges strict adherence to manufacturers’ reprocessing instructions and any of certain recommended supplemental measures to reduce contamination risks.
08/04/2015
 
 
TXT TriVascular’s Ovation iX Abdominal Stent Graft Approved [88 Words] [ Price : $8.95]
FDA approves a TriVascular Technologies PMA for the Ovation iX (integrated exchange) Abdominal Stent Graft System.
08/04/2015
 
 
TXT Guidance on OTC Pediatric Acetaminophen Products [82 Words] [ Price : $8.95]
FDA posts a guidance on Over-the-Counter Pediatric Oral Liquid Drug Products Containing Acetaminophen that is intended help drug makers minimize risks to consumers of acetaminophen-related liver damage.
08/04/2015
 
 
TXT FDA Safety Alert on Novartis’ Gilenya in Brain Disease [218 Words] [ Price : $8.95]
FDA issues a drug safety alert warning healthcare professionals and patients about a definitive case of progressive multifocal leukoencephalopathy (PML) and a probable PML case reported in patients taking Novartis’ Gilenya for multiple sclerosis.
08/04/2015
 
 
TXT Consent Decree Filed Against Supplement Makers [216 Words] [ Price : $8.95]
The U.S. government files a consent decree against three Wisconsin dietary supplement companies for not complying with FDA’s GMP regulations.
08/04/2015
 
 
TXT Guidance on 510(k) Refuse to Accept Policy [194 Words] [ Price : $8.95]
FDA releases a guidance on its Refuse to Accept Policy for 510(k)s that explains the procedures and criteria it intends to use in assessing whether submissions meets a minimum threshold of acceptability.
08/04/2015
 
 
TXT Workshop on Biomarkers in Drug Development [100 Words] [ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 8/21: “Evidentiary Considerations for Integration of Biomarkers in Drug Development.”
08/04/2015
 
 
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