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FDA grants Gibson Oncology a Rare Pediatric Disease Designation for LMP-400, the companys novel small molecule topoisomerase 1inhi...[ Price : $8.95]
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FDA issues a question-and-answer guidance on data integrity and compliance with drug CGMPs.[ Price : $8.95]
FDA issues a guidance explaining user fees and refunds for PMAs and some device BLAs as outlined in the MDUFA 4 agreement.