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FDA clears a Meridian Bioscience 510(k) for new claims for its illumigene pertussis molecular amplification test.[ Price : $8.95]
Federal Register Notice: FDA releases a guidance: Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Ap...[ Price : $8.95]
Regen BioPharma submits data and responses to questions posed by FDA regarding its IND for HemaXellerate, a cellular drug designed...[ Price : $8.95]
FDA says Hikma Pharmaceuticals has sufficiently corrected GMP violations at its Portuguese drug manufacturing facility.[ Price : $8.95]
FDA posts its fifth, sixth and seventh reports on backlogs in postmarketing reports and commitments.[ Price : $8.95]
FDA says that Merck and Pfizers avelumab is a breakthrough therapy for patients with metastatic Merkel cell carcinoma.[ Price : $8.95]
FDA makes presentations biomarkers, the benefit/risk framework, and patient-reported outcomes at a PDUFA 6 reauthorization stakeho...[ Price : $8.95]
CDRH director Jeffrey Shuren says his Center intends to finalize early next year its guidance on aFramework for Regulatory Oversig...