Remove Clinic Remove Government Remove Management Remove Manufacturing
article thumbnail

Green Practice News: May 2025

My Green Doctor

In This Issue : Why Renewable Energy Belongs in Every Clinic Medical Waste: One Model for Improvement OnTrack with your Sustainability Goals? Powering Health, Protecting the Planet – Why Renewable Energy Belongs in Every Clinic Healthcare professionals have always been trusted voices on public health.

article thumbnail

Keeping Your Company’s Federal Contracting Options Safe in the Face of Pending BIOSECURE Act Legislation

FDA Law

This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. Office of Management and Budget (OMB) can also specify other equipment or services to be subject to the Act’s prohibitions. House of Representatives ( H.B. 7085 ) and Senate ( S.B.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

News on FDA’s Quality Management Maturity Program-Maturity to Continually Improve and to not be Reactive

FDA Law

Brevig, Senior Regulatory Device and Biologics Expert — In January 2023, FDA published a paper summarizing its lessons learned from two pilot Quality Management Maturity (QMM) Pilot Programs, such as best practices for conducting QMM assessments and developing the QMM scoring system. By Holly N.

article thumbnail

The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Other medical information.

Clinic 52
article thumbnail

FDA Would Like to Join You in the Sandbox When Developing AI Enabled Devices

FDA Law

Both guidance documents recommend data management practices for collecting data for use in developing, tuning, and testing an artificial intelligence model and making changes to said model. FDA notes the use of data collected outside the U.S.

article thumbnail

Does the Drug Shortage White Paper Fall Short?

FDA Law

For generic drug manufacturing facilities specifically, the numbers are 63% and 87%. The proposed Manufacturing Resiliency Assessment Program (MRAP) would be managed as a public-private partnership and would assign resilience scores to manufacturers of generic drugs, “based on an assessment of manufacturer practices and past performance.”

article thumbnail

New Breakthrough Devices Program Guidance: Expanding Opportunities for Medical Product Innovations

FDA Law

This implies that if device technologies and features can produce a clinically meaningful impact for the treatment or diagnosis of a condition in certain populations, such data could support the case that the device satisfies the first designation criterion.

Medical 53