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FDA publishes 32 new and revised product-specific guidances to aid in development of generic drugs and a revised list of PSGs unde...[ Price : $8.95]
FDA grants Karius a breakthrough device designation for its Karius Test for use in the diagnosis and management of immunocompromis...[ Price : $8.95]
The Humane Society of the U.S. petitions FDA to take actions to inform drug developers and sponsors that they are not always requi...[ Price : $8.95]
The Alliance for a Stronger FDA urges Congress to provide FDA with $3.9 billion in budget authority for fiscal year 2025, which is...[ Price : $8.95]
FDA commissioner Robert Califf and associate commissioner for womens health Kaveeta Vasisht tout successes of the agencys Office o...[ Price : $8.95]
Eisai opens a rolling BLA submission for an autoinjector to deliver maintenance doses of Leqembi in patients with early Alzheimers...[ Price : $8.95]
Parenteral Technologies asks FDA to ban specific language from the directions for some liquid acetaminophen products indicated for...[ Price : $8.95]
FDA clears an Atraverse Medical 510(k0 for its Hotwire radiofrequency guidewire, a device that enables zero exchange left-heart ac...