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Sen. Ed Markey asks FDA to step up efforts to curb off-label prescribing of Insys Therapeutics fentanyl product Subsys.[ Price : $8.95]
FDA acting associate commissioner Janice Soreth says progress has been made on almost all of 27 action items intended to improve d...[ Price : $8.95]
In response to increasing data integrity citations in Warning Letters and inspections, FDA signs an agreement with CluePoints to d...[ Price : $8.95]
An extramural CDRH Case for Quality working group reports on initial steps to develop a standardized way for hospitals to compare ...[ Price : $8.95]
Federal Register Final Rule: FDA amends its regulations on the definition of a custom device to include new enumerated statutory r...[ Price : $8.95]
FDA grants MediciNova an orphan drug designation for MN-166 (ibudilast) for treating amyotrophic lateral sclerosis.[ Price : $8.95]
FDA clears a BioFire Diagnostics 510(k) for the FilmArrayRespiratory Panel EZ, intended for use in detecting 11 viral and three ba...[ Price : $8.95]
AstraZeneca says it has stopped a Phase 2a trial for asthma therapy AZD9412 (inhaled interferon beta) based on an interim analysis...