Remove Consulting Remove Manufacturing Remove Patients Remove Utilities
article thumbnail

Green Practice News: May 2025

My Green Doctor

This isn’t just about saving the planet—it’s also about saving money, protecting patients, and strengthening our healthcare systems from the inside out. Our Consulting Services offer customized strategies for group practices, health systems, and medical societies ready to accelerate their impact and lead the way in climate-smart care.

article thumbnail

Price Limits, Affordability Boards, Penalties, Oh My: Minnesota Enacts Sweeping Drug Pricing Reforms

FDA Law Blog

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below. Best price?

Insiders

Sign Up for our Newsletter

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

article thumbnail

The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

From new initiatives to facilitate faster reviews for new indications under the Split Real Time Application Review (STAR) pilot program, to bringing new meetings under PDUFA goals, to continued support for rare diseases and incorporation of the patient voice, the goals letter revealed a good number of welcome announcements.

article thumbnail

Are You Recall Ready? FDA Expects You to Be

FDA Law Blog

Almost all recalls are conducted on a voluntary basis by the manufacturer. FDA has model recall communication templates available here that firms can utilize. Manufacturers hope for the best that their products are going to be used safely and effectively for patients and consumers.

article thumbnail

Hearing Loss in Geriatrics and Palliative Care: A Podcast with Nick Reed and Meg Wallhagen

GeriPal

Association of Sensory and Cognitive Impairment With Healthcare Utilization and Cost in Older Adults. Including more hospital utilization or healthcare utilization, maybe cognitive impairment issues. My own work focuses on hospitalization and health utilization over time. Is that right? Is that right, Nick?

IT 102
article thumbnail

FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

After all, the labeling is intended to do exactly that: it informs patients and prescribers of the risks to ensure the product is used effectively and in a manner that mitigates risks, according to FDA’s understanding of the relevant science.