[ Price : $8.95]
Federal Register Notice: FDA releases a guidance on modifications to devices subject to PMA.[ Price : $8.95]
FDA tells Impax Laboratories that it needs to collect additional longer-term controlled clinical data on the safety and efficacy o...[ Price : $8.95]
FDA orders a boxed warning on labeling for two prescription bowel cleansing products due to risk of a type of kidney injury.[ Price : $8.95]
Federal Register Notice: FDA releases a revised draft guidance on the labeling of nonprescription human drugs products marketed wi...[ Price : $8.95]
Federal Register Final rule: FDA approves an Ivy Labs sANADA for increased levels of monensin in Type C medicated feeds for heifer...[ Price : $8.95]
FDA and HHS issue guidances on use of data when a subject is no longer participating in a clinical trial.[ Price : $8.95]
CDRH issues a guidance to help sponsors determine the type of regulatory submission needed to modify a lawfully marketed PMA devic...[ Price : $8.95]
Rep. Barton asks why FDA waited six months to seize contaminated heparin after twice warning the manufacturer that its recall effo...