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TXT Guidance on Labeling for Accelerated Approval Drugs/Biologics [113 Words] [ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.
03/25/2014
 
 
TXT BIO Seeks FDA Revamp of Drug Safety Labeling Changes [446 Words] [ Price : $8.95]
BIO asks FDA to revamp its proposed rule on post-approval drug safety labeling changes, including a different approach to allowing generic drug manufacturers to make their own changes.
03/25/2014
 
 
TXT Cook Wants Custom Devices Exempted from Listing Requirement [514 Words] [ Price : $8.95]
Cook Group tells FDA it disagrees with some provisions in an agency draft guidance on custom device exemptions.
03/25/2014
 
 
TXT Require Clinical Data in Most PMA Supplements: Authors [326 Words] [ Price : $8.95]
University of California San Francisco researchers say FDA should require clinical data in most PMA supplements so clinicians can better understand the cumulative effect of changes that have been made.
03/25/2014
 
 
TXT Ultradent Inspection Finds QS Violations [420 Words] [ Price : $8.95]
FDA’s Denver District Office warns Ultradent about Quality System violations in its manufacturing of dental brackets and other devices.
03/25/2014
 
 
TXT Perrigo Sues for Testosterone Gel TE Rating [338 Words] [ Price : $8.95]
Perrigo sues FDA in DC federal court seeking an order to force the agency to assign a therapeutic equivalence rating to its testosterone product.
03/25/2014
 
 
TXT FDA Reviewers Doubt Reasanz Efficacy [425 Words] [ Price : $8.95]
FDA medical reviewers advise against approving Novartis Reasanz due to lack of efficacy in improving the symptoms of acute heart failure.
03/25/2014
 
 
TXT Woodcock Says Generic Drug Critic ‘Contaminated’ Samples [312 Words] [ Price : $8.95]
CDER director Janet Woodcock says a researcher who found contaminants in generic cholesterol drugs produced overseas contaminated the samples himself through an improper testing procedure.
03/25/2014
 
 
TXT FDA Ready to Revamp OTC Drug Monograph System: Woodcock [1243 Words] [ Price : $8.95]
CDER director Janet Woodcock tells a public hearing that the Center is ready to revamp its over-the-counter drug monograph system because after 40 years it has become outdated.
03/25/2014
 
 
TXT CDRH Guidance on Pediatric Medical Devices [85 Words] [ Price : $8.95]
CDRH releases a new guidance on “Premarket Assessment of Pediatric Medical Devices.”
03/25/2014
 
 
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