Philips Respironics recalls (Class 1) certain BiPAP (bi-level positive airway pressure) ventilators that may contain a plastic contaminated with a non...
FDA releases an immediately-in-effect guidance entitled Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act (DSCSA...
Federal Register notice: FDA sends to OMB an information collection extension for abbreviated new animal drug applications.
Federal Register notice: FDA renews its Arthritis Advisory Committee for an additional two years.
Federal Register notice: FDA makes available a final guidance entitled Electronic Submission Template for Medical Device 510(k) Submissions.
PhRMA says the FDA Oncology Center of Excellence Real-Time Oncology Review (RTOR) program should be expanded to include tissue and cell products regul...
Five stakeholders comment on an FDA draft guidance on therapeutic equivalence evaluations.
The CDER Office of Prescription Drug Promotion says it wants to expand a current study on endorsers in print and Internet ads to cover TV spots.