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FDA warns Earth City, MO-based Legacy Pharmaceutical Packaging about CGMP violations and insanitary conditions in its manufacturin...[ Price : $8.95]
FDA extends the deadline for comments on a draft guidance intended to improve labeling for LASIK devices used in vision correction...[ Price : $8.95]
The Washington DC District Court rules against FDA in granting summary judgment to plaintiff Melinta Therapeutics that suspends th...[ Price : $8.95]
FDA explains why it is proposing to refuse to approve a Vanda sNDA for a new indication for Hetlioz.[ Price : $8.95]
The Outsourcing Facilities Association and FDA reach a settlement agreement that compels the agency to promptly review long-pendin...[ Price : $8.95]
Hyman, Phelps & McNamara attorneys and a medical device regulatory expert say an FDA final guidance on clinical decision support s...[ Price : $8.95]
Reuters reports that FDA has again found quality issues at the Lilly Branchburg, NJ, drug manufacturing facility.[ Price : $8.95]
FDA accepts for priority review a Gilead Sciences supplemental BLA for Trodelv (sacituzumab govitecan-hziy) for treating certain a...