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Luitpold Pharmaceuticals and four patient advocacy groups question an FDA draft guidance on determining bioequivalence for generic...[ Price : $8.95]
Federal Register Final rule: FDA amends the animal drug regulations to reflect August NADA approvals and to reflect sponsor change...[ Price : $8.95]
Federal Register Notice: FDA publishes a list of approved PMAs and their safety and effectiveness summaries.[ Price : $8.95]
Former FDA commissioner David Kessler says that doctors are unduly influenced by drug company promotional activities.[ Price : $8.95]
FDA approves Sigma Tau Pharmaceuticals Cystaran 0.44%, a topical ophthalmic therapeutic for treating corneal cystine crystal accum...[ Price : $8.95]
FDA, in partnership with international regulatory and law enforcement agencies, takes enforcement actions this week against more t...[ Price : $8.95]
FDA clears a Covidien 510(k) for the Nellcor Bedside Respiratory Patient Monitoring System.[ Price : $8.95]
Medical device manufacturers and advocacy groups suggest changes and clarifications they believe are needed in FDAs draft guidance...