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FDA grants Noninvasix a breakthrough device designation for its LivOx Central Venous Oxygenation Monitor for monitoring central ve...[ Price : $8.95]
Federal Register notice: FDA announces a 3/22 virtual public meeting on the biosimilar user fee programs enhanced review transpare...[ Price : $8.95]
CDER Office of Prescription Drug Promotion senior social science research analyst Katherine Aikin explains the work her unit does ...[ Price : $8.95]
The CDER Office of Pharmaceutical Quality reports on its 2021 core function activities and efforts to carry out White House recomm...[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Nonclinical Considerations for Mitigating Nonhuman Primate ...[ Price : $8.95]
AdvaMed comments on an FDA proposed information collection to prepare transition plans for some medical devices after the Covid-19...[ Price : $8.95]
FDA issues a second complete response letter in less than 18 months to Mallinckrodt for its NDA for terlipressin to treat adults w...[ Price : $8.95]
FDA releases a lengthy FDA-483 with 13 observations from a two-month inspection at Colchester, VT-based Edge Pharma drug outsourci...