FDA Related News

Medical Devices

Medifocus Completes Prolieve Post-Approval Study

FDA finishes its review of a Medifocus Prolieve post-approval study that the company says confirms the treatments long-term safety, efficacy, and dura...

Medical Devices

EOS Imaging Hip Surgical Planning Software Cleared

FDA clears an EOS Imaging 510(k) for its hipEOS 3.0 surgical planning software.

Medical Devices

FDA Clears Phillips New MR System

FDA clears a Royal Philips 510(k) for the Ingenia Elition 3.0T magnetic resonance (MR) device and two clinical applications, Philips Compressed SENSE ...

Human Drugs

FDA Wants More Efficient Drug Development Continuum

FDA commissioner Scott Gottlieb says the agency is taking steps to make the drug development continuum more efficient and cost-effective.

Creative Science Marketing Unapproved New Animal Drug: FDA

FDA warns Creative Science it is marketing an unapproved new animal drug.

Medical Devices

Spineology Rampart Interbody Fusion Device Cleared

FDA clears Spineology 510(k) for its Rampart One Standard ALIF interbody fusion system for use with or without supplemental fixation.

Human Drugs

Mylans Neulasta Biosimilar Approved by FDA

FDA approves Mylans Fulphila (pegfilgrastim-jmdb) as the first biosimilar to Amgens Neulasta (pegfilgrastim) to decrease the chance of infection as su...

Federal Register

Medical Image Analyzers Reclassified into Class 2

Federal Register notice: FDA issues a proposed order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast les...

Federal Register

Draft Guide on Adolescent Patients in Oncology Trials

Federal Register notice: FDA makes available a draft guidance entitled Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clini...

Human Drugs

Woodcock Unveils Proposed Overhaul of CDER Drug Review

CDER director Janet Woodcock proposes changes to her Centers new drug regulatory program that are intended to free up resources so staff can focus on ...