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Federal Register notice: FDA makes available a guidance entitled Allergic Rhinitis: Developing Drug Products for Treatment.[ Price : $8.95]
CDER issues a MAPP clarifying the refuse-to-file process for specific types of drug applications.[ Price : $8.95]
Intuitive Surgical files a 510(k) for the companys new flexible robotic-assisted, catheter-based platform for lung airway biopsies...[ Price : $8.95]
FDA deputy commissioner Anna Abram says the agency is making significant progress on action plans to improve drug competition and ...[ Price : $8.95]
Federal Register notice: FDA extends the comment period on six draft guidance documents about developing human gene therapy produc...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Consideration of Uncertainty in Making Benefit-Risk Determi...[ Price : $8.95]
FDA clears an AMDT Holdings 510(k) for its SixFix deformity analysis and correction software and instrumentation.[ Price : $8.95]
Beaumont Bio Med recalls its entire aqueous/alcohol-based product line due to possible microbial contamination.