Stakeholders look for ways to improve meaningful communication between the Office of New Drugs and stakeholders involved in drug development.
The FY 2019 report issued by CBER director Peter Marks touts several different types of drug and vaccine approvals.
FDA clears an IceCure Medical 510(k) for its Cryoablation Technology and its use to destroy benign and cancerous tumors by freezing them.
FDA approves Abbotts new alternative surgical technique for its HeartMate 3 heart pump that will allow more advanced heart failure patients to avoid o...
FDA schedules a 3/27 public meeting on modernization of the agencys data strategy.
Emery Pharma calls on FDA to take multiple steps to control ranitidine products that can develop NDMA when exposed to high temperatures such as during...
Stakeholders raise questions on an FDA draft guidance on submitting IND safety reports in electronic format to FAERS.
Teva agrees to pay $54 million to settle a whistleblower suit alleging that it used sham speaker and consulting programs to reward doctors for prescri...