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FDA makes available a revised draft guidance entitled Conducting Remote Regulatory Assessments (RRA) Questions and Answers.[ Price : $8.95]
Federal Register notice: FDA announces the renewal of its Vaccines and Related Biological Products Advisory Committee for an addit...[ Price : $8.95]
FDA tells Liquidia Corp. that its earlier user fee review action target date of 1/24 will be missed on the companys NDA for Yutrep...[ Price : $8.95]
A Sheppard Mullin report describes several FDA issues that life sciences companies can expect to face in 2024.[ Price : $8.95]
FDA says it is looking for nine drug establishments to volunteer to test CDERs new QMM prototype assessment protocol.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Revising ANDA Labeling Following Revision of the RLD Labeli...[ Price : $8.95]
FDA releases the form FDA-483 with 11 observations from an inspection at the Deerfield, FL-based Hybrid Pharma outsourcing facilit...[ Price : $8.95]
The CDER Office of Clinical Pharmacology launches a Web site to give healthcare professionals examples of drug interactions involv...