FDA Related News

Federal Register

Proposed Rule to Update Combo Product Regulations

Federal Register proposed rule: FDA proposes to amend its regulations concerning the classification of products as biologics, devices, drugs, or combi...

Human Drugs

Steps to Expedite Biosimilar Market Entry: Petition

The University of Illinois at Chicago College of Pharmacy suggests FDA take five steps to speed development and approval of biosimilars.

Stakeholders Question Healthcare Professional Survey

Three stakeholders raise concerns and questions about FDA-proposed research surveying healthcare professionals on aspects of prescription drug promoti...

Federal Register

Public Meeting on Chronic Pain Patient Input

Federal Register notice: FDA announces a 7/9 public meeting on Patient-Focused Drug Development for Chronic Pain that is intended to provide patients ...

Federal Register

Pediatric Oncology Drugs Advisory Committee Meeting 6/20

Federal Register notice: FDA announces a Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee meeting 6/20 to review and discuss ...

Human Drugs

CGMP Deviations at Indias Reine Lifescience

FDA warns Indias Reine Lifescience about CGMP deviations in its manufacturing of active pharmaceutical ingredients.

Human Drugs

Ei Inspection Finds CGMP Violations

FDA warns Ei LLC about significant violations of CGMP in its manufacturing of finished pharmaceuticals.

Human Drugs

PDUFA 6 Policy Changes Outlined

FDA asks drug manufacturers to update their PDUFA 6 information and be aware of policy changes under PDUFA.

Medical Devices

FDA Sees No Justification for More Device Servicing Regs

FDA says there are steps CDRH will take to promote improved servicing of medical devices without imposing new regulations that cant be justified by ob...

Medical Devices

HHS Security Alerts Cite Philips, GE, and Silex Devices

Healthcare IT News says two HHS cybersecurity alerts describe serious security flaws in Philips, GE, and Silex medical devices.