FDA Related News

Federal Register

Guidance on Device Patient Data Sharing

Federal Register notice: FDA makes available a guidance entitled Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients...

Human Drugs

Multiple Violations in Kim Chemicals Inspection

FDA warns Indias Kim Chemicals about CGMP and other violations in its manufacturing of OTC products.

Medical Devices

Safety Concern Continues with Abbotts Absorb Scaffold: FDA

An FDA safety update says that interim study results from a pivotal clinical trial continue to show an increased rate of major adverse cardiac events ...

Human Drugs

CGMP Violations at Accelerated Analytical Labs

FDA warns Accelerated Analytical Laboratories about CGMP violations at its drug manufacturing facility.

Human Drugs

FDA Recognizes Drug Inspections by 8 European Countries

FDA says it will recognize drug manufacturing inspections from eight European countries, avoiding duplication of inspections and resources.

Human Drugs

Accelerated Approval for AstraZenecas Calquence

As a condition of approval, FDA is requiring that AstraZeneca conduct additional studies to verify and describe anticipated clinical benefits of Calqu...

Medical Devices

FDA Encouraging Device Security Updates

CDRH associate director Suzanne Schwartz says the agency works with medical device manufacturers to address cybersecurity issues.

NJ Proposes Limits on Payments, Gifts to Prescribers

Attorney Serra Schlanger says New Jersey is considering a proposal to restrict drug company payments and gifts to healthcare professionals with author...

Medical Devices

Abbott Alinity ci-Series Instruments Cleared

FDA clears an Abbott 510(k) for its Alinity ci-series instruments for clinical chemistry and immunoassay diagnostics.

Human Drugs

HHS Needs Better Opioid Treatment Evaluation: GAO

The Government Accountability Office says HHS needs a better way of assessing the effectiveness of its efforts to combat the opioid addiction crisis b...