FDA revises its Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain.
FDA releases an FDA-483 with three observations from an inspection at Indias Shilpa Medicare Limited.
Federal Register notice: FDA classifies the temporary catheter for embolic protection during transcatheter intracardiac procedures into Class 2 (speci...
The Biosimilars Council says a Pennsylvania federal court should hear Pfizers suit charging Janssen with leveraging insurer rebates for its Remicade t...
Pew calls on HHS to support adding unique device identifiers to claims data to help patient decision making and save healthcare system funds.
FDA releases its latest batch of Warning Letters that includes Daito Kasei Kogyo Co., Light Age and Hunan Norchem Pharmaceutical Co.
FDA clears a Multi Radiance Medical 510(k) for the MR4 Laser technology for neck and shoulder pain relief.
FDA warns Light Age about 12 Quality System Regulation violations in its manufacturing of Class 2 medical lasers.