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QT Imaging Gets Clearance for Breast Scan Calculation

[ Price : $8.95]

FDA grants QT Imaging a 510(k) clearance for its QTscan to calculate the fibroglandular volume of the breast and the ratio of that...

Philips Recalls Ventilators Over Contaminated Plastic

[ Price : $8.95]

Philips Respironics recalls (Class 1) certain BiPAP (bi-level positive airway pressure) ventilators that may contain a plastic con...

Naloxone Guidance Attempts to Ease Availability

[ Price : $8.95]

FDA releases an immediately-in-effect guidance entitled Exemption and Exclusion from Certain Requirements of the Drug Supply Chain...

Info Collection on Abbreviated Animal Drug Apps

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for abbreviated new animal drug applications.

Arthritis Advisory Committee Renewed for 2 Years

[ Price : $8.95]

Federal Register notice: FDA renews its Arthritis Advisory Committee for an additional two years.

Final Guide on 510(k) Template for eSubmission

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Electronic Submission Template for Medical Device 510(k) Su...

Expand RTOR to Cell, Tissue Products: PhRMA

[ Price : $8.95]

PhRMA says the FDA Oncology Center of Excellence Real-Time Oncology Review (RTOR) program should be expanded to include tissue and...

Comments on Therapeutic Equivalence Draft Guidance

[ Price : $8.95]

Five stakeholders comment on an FDA draft guidance on therapeutic equivalence evaluations.

OPDP to Study TV Ad Endorsers

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion says it wants to expand a current study on endorsers in print and Internet ads to c...

2 Prescription Drug Promotion Studies Proposed

[ Price : $8.95]

The CDER Office of Prescription Drug Promotion proposes to study consumer and healthcare provider perceptions about drugs that com...