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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.

Human Drugs

Generic Drugs Not Covered by West Virginia Tort Law

A West Virginia appeals court says its state law does not allow liability of a branded drug company for an injury caused by a generic version of the d...

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Product Quest MFG and Reine Lifescience.

Federal Register

Draft Guide on Pediatric HIV Studies

Federal Register notice: FDA makes available a draft entitled Pediatric HIV Infection: Drug Development for Treatment.