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FDA General

FDA Alliance Advocates for Increased FDA Funding

The Alliance for a Stronger FDA advocates for increased FDA funding in fiscal year 2020 because growing responsibilities require a budget that grows....

Medical Devices

Zimmer ROSA Brain System Recall Class 1

FDA says the Zimmer Biomet recall of ROSA 3.0 robotic surgery systems is Class 1.

Human Drugs

Tripartite Meeting Looks at Antibacterial Regulation

Representatives from FDA, the European Medicines Agency and the Japanese Pharmaceuticals and Medical Devices Agency are working on alignment on clinic...

Human Drugs

Equipment Contamination Seen in 2 Aurobindo Inspections

Indias The News Minute says FDA inspections at two Aurobindo drug manufacturing facilities raised concerns about equipment contamination.

Medical Devices

Conformis Hip System Cleared

FDA clears a Conformis 510(k) for its Conformis Hip System.

Human Drugs

FDA Needs AI Standards: Executive

Charles Fisher, who founded an artificial intelligence company that works in drug clinical trials, urges FDA to develop a framework under which sponso...

Medical Devices

FDA in 2 Collaborative Communities

CDRHer Michelle Tarver says FDA is participating in two collaborative communities and wants to be in 10 by the end of 2020.

Human Drugs

FDA Clears Dx 360 Rotatable Disposable Sheath

FDA clears a UVision360 510(k) for the 3mm Luminelle Dx 360 Rotatable Disposable Sheath, an attachment for the Luminelle DTx Hysteroscopy System.

Human Drugs

Recommendations for Neonatal Pharmacology Guidance

Four stakeholders praise and recommend changes to an FDA draft guidance on general clinical pharmacology considerations for neonatal studies for drugs...

Human Drugs

CDER Office of Hematology, Oncology Products Reorganized

CDER has completed reorganization of the Office of Hematology and Oncology Products into the Office of Oncologic Diseases.