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TXT NE Compounding Center Owner Fights Fraud Claim [2823 Words] [ Price : $8.95]
A part owner of the defunct New England Compounding Center says he canít be guilty of fraud against FDA because there was no legal bright line difference between drug manufacturers and drug compounders.
04/18/2017
 
 
TXT Campaign Needed to Boost Trial Enrollment: Coalition [2821 Words] [ Price : $8.95]
The Coalition for Clinical Trial Awareness asks Congress to include in PDUFA a three-step process to raise awareness of the value of clinical trials and encourage patients to enroll.
04/18/2017
 
 
TXT FDA Denies Metabolic Therapy OTC Petition [2702 Words] [ Price : $8.95]
FDA denies a Metabolic Therapy petition to amend an OTC monograph to indicate that melatonin and IP6 are safe and effective for analgesic drug products for lack of sufficient information and supporting documentation.
04/18/2017
 
 
TXT FDA Denies Petition to Amend Inform Consent Documents [2668 Words] [ Price : $8.95]
FDA denies a Center for Responsible Science petition asking for three specific warnings in informed consent documents.
04/18/2017
 
 
TXT Latest FDA Warning Letters [153 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes one citing Targeted Medical Pharma.
04/18/2017
 
 
TXT Topics Suggested for Combination Products Policy Council [2799 Words] [ Price : $8.95]
Three stakeholders suggest topics for the FDA Combination Products Policy Council to address.
04/18/2017
 
 
TXT FDA Class 1 Recall on Medtronic Field Action [172 Words] [ Price : $8.95]
FDA classifies as a Class 1 recall a Medtronic voluntary field action related to its HVAD System Controllers and DC Adapters.
04/18/2017
 
 
TXT AMAG Pharma sNDA for Makena Subcutaneous Formulation [96 Words] [ Price : $8.95]
AMAG Pharmaceuticals files a supplemental NDA for Makena (hydroxyprogesterone caproate injection) to allow a subcutaneous auto-injector to deliver the drug.
04/17/2017
 
 
TXT CytoDyn Orphan Drug Request Rejected by FDA [203 Words] [ Price : $8.95]
FDA denies a CytoDyn request for an orphan drug designation for PRO 140 because the therapy appears to have the potential to treat more than just the subset of multi-drug resistant HIV patients for which the designation was requested.
04/17/2017
 
 
TXT When FDA Goes to Bat for One Company Against Another [2952 Words] [ Price : $8.95]
Editor Jim Dickinson analyzes a remarkable case of apparent and highly questionable FDA collusion with a medical device companyís marketing campaign against its primary competitor in infusion products.
04/17/2017
 
 
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