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Federal Register notice: FDA seeks comments on an information collection extension for Index of Legally Marketed Unapproved New An...[ Price : $8.95]
A CDER report on 2019 novel drug approvals shows that 60% of the 48 drugs approved came under at least one expedited development a...[ Price : $8.95]
Stakeholders look for ways to improve meaningful communication between the Office of New Drugs and stakeholders involved in drug d...[ Price : $8.95]
The FY 2019 report issued by CBER director Peter Marks touts several different types of drug and vaccine approvals.[ Price : $8.95]
FDA clears an IceCure Medical 510(k) for its Cryoablation Technology and its use to destroy benign and cancerous tumors by freezin...[ Price : $8.95]
FDA approves Abbotts new alternative surgical technique for its HeartMate 3 heart pump that will allow more advanced heart failure...[ Price : $8.95]
FDA schedules a 3/27 public meeting on modernization of the agencys data strategy.[ Price : $8.95]
Emery Pharma calls on FDA to take multiple steps to control ranitidine products that can develop NDMA when exposed to high tempera...