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FDA releases the form FDA-483 with five observations from an inspection at the Ripley, MS-based Delta Pharma outsourcing facility.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Policy for Coronavirus Disease 2019 Tests During the Publi...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Providing Over-the-Counter Monograph Submissions in Electro...[ Price : $8.95]
Two Hyman, Phelps & McNamara attorneys caution that actions providers take in response to an FDA safety communication could be see...[ Price : $8.95]
Covington attorneys say the Justice Department has signaled it remains interested in pursuing False Claims Act cases premised on v...[ Price : $8.95]
FDA publishes a draft guidance on the required electronic format for submission of over-the-counter monographs.[ Price : $8.95]
FDA updates its Covid-19 test policy to send more tests through the traditional review pathways and away from emergency use author...[ Price : $8.95]
Federal Register notice: FDA modifies the organizational structure of the Office of Regulatory Affairs and field offices.