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Washington Legal Foundation says an FDA proposed guidance on medical device reporting imposes new requirements on manufacturers th...[ Price : $8.95]
Speakers at a Washington Legal Foundation briefing outline significant problems they see with FDAs draft guidance on the 510(k) pa...[ Price : $8.95]
Boston Scientific and its Guidant subsidiary agree to pay $30 million to settle government allegations that Guidant knowingly sold...[ Price : $8.95]
FDA extends by three months its review of an AMAG Pharmaceuticals supplemental NDA for Feraheme (ferumoxytol) injection for intrav...[ Price : $8.95]
Merck subsidiary EMD Serono gains FDA approval for its Gonal-f RFF Redi-ject (follitropin alfa injection), a disposable pre-filled...[ Price : $8.95]
FDA asks Infective Drugs Advisory Committee members to discuss whether Paladin Therapeutics has demonstrated safety and effectiven...[ Price : $8.95]
FDA says the St. Jude Amplatzer atrial septal occluder may have rare adverse events that could lead to emergency surgery.[ Price : $8.95]
FDA tells Vanda Pharmaceuticals that the agencys Peripheral and Central Nervous System Drugs Advisory Committee 11/14 will review ...