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TXT ProPublica Questions ‘Double Dip’ Company Payments to Docs [377 Words] [ Price : $8.95]
A ProPublica investigative journalism report details case studies of several doctors who receive drug company research grants and also receive personal speaking and consulting fees from the same companies.
03/25/2014
 
 
TXT Don't Include Drugs in Supreme Court Decision: GPhA Brief [298 Words] [ Price : $8.95]
Generic drug makers urge the U.S. Supreme Court to limit its decision in Pom Wonderful vs. Coca-Cola to food labeling and not broaden it to include drug products.
03/25/2014
 
 
TXT Latest Warning Letters [256 Words] [ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Smruthi Organics and Ultradent Products.
03/25/2014
 
 
TXT FDA Updates Device Classification Regs [71 Words] [ Price : $8.95]
Federal Register Proposed rule: FDA proposes to update its regulations on classification and reclassification of medical devices and to conform to provisions in the FDA Safety and Innovation Act.
03/25/2014
 
 
TXT Animal Drug Sponsor Change to Zoetis [94 Words] [ Price : $8.95]
Federal Register Final rule: FDA is amending the animal drug regulations to reflect a change of sponsor for 104 approved NADAs and 5 ANADAs from Pfizer to Zoetis and making minor corrections.
03/25/2014
 
 
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Federal Register Notice: FDA releases a draft guidance: Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.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Cook Group tells FDA it disagrees with some provisions in an agency draft guidance on custom device exemptions.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
 
 
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