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Federal Register Notice: FDA releases a draft guidance: Medical Device Development Tools.[ Price : $8.95]
Johnson & Johnsons device unit, Depuy, reportedly agrees to pay more than $4 billion to settle thousands of lawsuits over its reca...[ Price : $8.95]
Troubled Hospira says it was recently inspected by FDA at its Lake Forest, IL and McPherson, KS facilities.[ Price : $8.95]
FDA asks Biogen Idec for additional process validation information for its blood clotting factor Eloctate.[ Price : $8.95]
CDRH posts a draft guidance on Medical Device Development Tools that outlines a voluntary process for qualifying medical device de...[ Price : $8.95]
FDA accepts for review an NPS Pharmaceuticals supplemental NDA for Gattex (teduglutide [rDNA origin]) for injection, which is curr...[ Price : $8.95]
FDA asks manufacturers of certain OTC topical antiseptics to revise the products labels and packaging to help prevent infections i...[ Price : $8.95]
FDA grants Mast Therapeutics an orphan drug designation for MST-188 for treating acute limb ischemia.