FDA Related News

Human Drugs

3 FDA Innovative Manufacturing Action Steps

FDA issues a strategy document on innovative manufacturing technologies with three action steps it will take.

Medical Devices

FDA Warns 2 Chinese Labs About Data Concerns

FDA says it sent Warning Letters to two Chinese nonclinical labs airing concerns about data integrity.

Human Drugs

Lawsuit Against FDA Dismissed on Ripeness Grounds

The Washington, DC District Court dismisses a Vanda Pharmaceuticals lawsuit against FDA that challenged the agencys bioequivalence determination of a ...

Human Drugs

Ocaliva Confirmatory Trial Fails: FDA

FDA asks members of its Gastrointestinal Drugs Advisory Committee whether they believe that the benefits of using Intercepts Ocaliva to treat some cas...

Biologics

GSK Nixes Herpes Simplex Virus Vaccine

GSK decides to not advance the development of an investigational herpes simplex virus vaccine candidate based on data from a recent Phase 1-2 study.

Medical Devices

Hinge Health Wireless Pain Device Cleared

FDA clears a Hinge Health 510(k) for its Enso 3, a wireless device for reducing musculoskeletal pain.

Human Drugs

CDER Quantitative Medicine CoE Explained

CDER Quantitative Medicine Center of Excellence lead Rajanikanth Madabushi explains the new units role in drug development and regulatory review.

Human Drugs

CGMP Violations at Zydus Lifesciences Facility

FDA warns Zydus Lifesciences Limited about CGMP violations in its production of finished drugs.

Medical Devices

Multiple Optikem International Violations Cited

FDA warns Denver, CO-based Optikem International about Quality System Regulation and other violations in its production of ophthalmic solutions.

Changes Sought in FDA Misinformation Guidance

Three trade groups representing companies regulated by FDA recommend changes to a draft guidance on addressing misinformation about prescription drugs...