FDA Related News

Medical Devices

Companion Medical InPen Insulin Calculator Cleared

FDA clears a Companion Medical 510(k) for its InPen bolus insulin calculator for fixed dosing and meal estimation.

Human Drugs

Cerovene Generic Daraprim Approved

FDA approves a Cerovene ANDA for the first generic copy of Vyera Pharmaceuticals Daraprim (pyrimethamine) tablets for treating toxoplasmosis.

Medical Devices

Baxter Peri-Strips Dry with Secure Grip Cleared

FDA clears a Baxter International 510(k) for its Peri-Strips Dry with Veritas Collagen Matrix, a staple line reinforcement material for bariatric surg...

Federal Register

CDRH 510(k) eSubmission Template Pilot

Federal Register notice: CDRH has announced a voluntary Electronic Submission Template and Resource (eSTAR) Pilot.

Federal Register

Standardized Medicated Feed Assay Limits Guide

Federal Register notice: FDA makes available a draft guidance for industry #264 entitled Standardized Medicated Feed Assay Limits.

Comments on Combination Product Draft Guidance

PhRMA and AdvaMed suggest changes to an FDA draft guidance on feedback on combination products.

Human Drugs

Zogenix Review Extension for Dravet Syndrome Drug

FDA extends by three months its review of a Zogenix NDA for Fintepla (fenfluramine oral solution) for treating seizures associated with Dravet syndrom...

Medical Devices

Framework for Device Real-World Evidence Studies

NESTcc publishes its data quality framework and methods framework for use in real-world evidence studies.

Human Drugs

American Health Packaging Recalls Some Ranitidine for NDMA

American Health Packaging recalls 11 lots of ranitidine tablet unit dose blisters due to potential NDMA contamination.

Human Drugs

Panel Delivers Mixed Vote on Lillys Cyramza

FDAs Oncologic Drugs Advisory Committee delivers a mixed vote (six to five) to support approval of Eli Lillys supplemental BLA for Cyramza (ramuciruma...