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FDA invites medical device manufacturers to participate in a single audit program covering five countries.[ Price : $8.95]
A tripartite meeting last week between FDA, European Medicines Agency and Japans Pharmaceuticals and Medical Devices Agency reach ...[ Price : $8.95]
The House Energy and Commerce Committee calls on FDA to expedite developing guidance on Constitutionally-sound off-label communica...[ Price : $8.95]
A lengthy Reuters investigative report airs criticism about the lack of successful prosecutions in cases investigated by the FDA O...[ Price : $8.95]
Vanda asks FDA not to approve any generic Fanapt until expiration of a three-year exclusivity period granted for labeling changes ...[ Price : $8.95]
An International Pharmaceutical Regulators Forum working group solicits comment on principles for extrapolating biosimilar indicat...[ Price : $8.95]
Tonix says its TNX-102 SL failed to reach statistical significance in a Phase 3 fibromyalgia trial and will now move to a Phase 3 ...[ Price : $8.95]
FDA extends the compliance date for UDI label and global database submissions to 9/24/18 for certain Class 1 medical devices.