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Five stakeholders comment on an FDA draft guidance on therapeutic equivalence evaluations.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.
The CDER Office of Prescription Drug Promotion proposes to study consumer and healthcare provider perceptions about drugs that come with medication tr...
FDA approves two Medtronic drug-eluting stents for use in treating non-left main bifurcation lesions in the heart.
FDA clears an Iterative Scopes 510(k) for SKOUT, a computer-aided polyp detection device for adults undergoing colorectal cancer screening.
Senate Health, Education, Labor and Pensions Committee leaders reach agreement to reauthorize FDAs user fee programs for an additional five years, wit...
