FDA Related News

Human Drugs

Biocon FDA-483 Released

FDA issues an FDA-483 with six observations from an inspection at Biocon, a Malaysian sterile drug producer.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that includes Dexcowin Co., Laser Dental Innovations and Quali-Controle & Quali-Controle.

Federal Register

Guidance on Assessing DNA Reactive (Mutagenic) Impurities

Federal Register notice: FDA makes available a guidance entitled M7(R1): Assessment and Control of Deoxyribonucleic Acid (DNA) Reactive (Mutagenic) Im...

Federal Register

DTC Study to Evaluate Adequate Provision for Non-Web Users

Federal Register notice: FDA seeks OMB approval for a new proposed information collection for a drug direct-to-consumer broadcast advertising study en...

Human Drugs

Revised Right-to-Try Bill Introduced in House

Lawmakers introduce a revised Right to Try bill in the House to improve access to experimental treatments for patients

Human Drugs

FDA Dispute Resolution Action Seeks Another Hikma Study

FDA dispute resolution action reaffirms a 2017 complete response letter denying approval of a Hikma Pharmaceuticals ANDA for a generic version of Glax...

Medical Devices

FDA Clears DeGen Medical Modular Pedicle Screw

FDA clears a DeGen Medical 510(k) for the E3 MIS Modular Pedicle Screw System for thoraco-lumbar spine.

Medical Devices

Medtronic Gains Approval of Guardian Connect Glucose Monitor

FDA approves a Medtronic PMA for its Guardian Connect continuous glucose monitoring system for people with diabetes ages 14 to 75 years.

Medical Devices

Jury Awards $35 Million in Pelvic Mesh Case

A jury in Northern District of Indiana federal court returns a $35 million verdict in favor of plaintiffs Barbara and Anton Kaiser for alleged injurie...

New DTC Study Examining Adequate Provision for Non-Web Users

FDA announces new research to be conducted on direct-to-consumer (DTC) ads Utilization of Adequate Provision Among Low to Non-Internet Users.