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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug develo...[ Price : $8.95]
Federal Register notice: FDA seeks comments on a proposed information collection for Collection of Information for Participation i...[ Price : $8.95]
FDA issues a draft guidance on Clinical Immunogenicity Considerations for Biosimilar and Interchangeable Insulin Products.[ Price : $8.95]
FDA clears a Renovia 510(k) for its next-generation Leva Pelvic Digital Therapeutic for strengthening pelvic floor muscles and tre...[ Price : $8.95]
FDA issues Adamis Pharmaceuticals a complete response letter on its NDA for Adamis ZimHi (naloxone) high-dose injection for treati...[ Price : $8.95]
CDER Office of Prescription Drug Promotion sends Rockwell Medical an untitled letter after reviewing the companys Triferic Web pag...[ Price : $8.95]
Federal Register notice: FDA reopens for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applicati...[ Price : $8.95]
FDA accepts for priority review an Intercept Pharmaceuticals NDA for obeticholic acid seeking accelerated approval for treating fi...