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Revised Guidance on Formal Dispute Resolution

[ Price : $8.95]

Federal Register Notice: FDA releases a revised draft guidance: Formal Dispute Resolution: Appeals Above the Division Level for CD...

Workshop on Human Genetic Variants Databases

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 11/13: Use of Databases for Establishing the Clinical Relevance of Human Gene...

Workshop on NGS In Vitro Diagnostic Tests

[ Price : $8.95]

Federal Register Notice: FDA plans a public workshop 11/12: Standards-Based Approach to Analytical Performance Evaluation of Next ...

Panel to Discuss NDA for Depressive Disorder

[ Price : $8.95]

Federal Register Notice: FDAs Psychopharmacologic Drugs Advisory Committee will meet 12/1 to discuss a Fabre-Kramer Pharmaceutical...

Comments Reopened on Homeopathic Products

[ Price : $8.95]

Federal Register Notice: FDA reopens the comment period on a public hearing on the use of human drug and biologics labeled as home...

FDA Posts Guide on Endocrine-Related Toxicity

[ Price : $8.95]

FDA posts a final guidance on Nonclinical Evaluation of Endocrine-Related Drug Toxicity that provides recommendations to sponsors ...

FDA Guidance on Dispute Resolution

[ Price : $8.95]

FDA posts a draft guidance on Formal Dispute Resolution: Appeals Above the Division Level that provides recommendations for indust...

Did Bard Submit Forged Recovery Filter Application?

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NBC News says it was told by a former Bard employee that the companys FDA application for its Recovery blood clot filter may have ...

FDA Sees Potential Avridi Dosing Errors

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FDA medical reviewers caution that the requirement to dose Purdues Avridi without food could lead to reduced pain relief and conse...

MDR Violations Identified in Cellestis Inspection

[ Price : $8.95]

FDAs Los Angeles District Office warns Cellestis about Medical Device Reporting regulation violations.