Sound Physicians

APRIL 28, 2025

Still, we know that sometimes the final decision comes down to a single factor: cost. While we’ve earned our reputation over the decades for our clinical excellence in hospital medicine , we’ve also earned — somewhat unfairly — a reputation for being more expensive than our competitors. percent and 5.7 percent annually.

IT 52

IT Hospital Telemedicine Clinic 52

FDA Law Blog

OCTOBER 10, 2022

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019.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

Clinic Medical Provider Patients 52

FDA Law Blog

NOVEMBER 1, 2022

Agency often sees issues when the drug product is put on an expedited manufacturing or an expedited clinical program. As the clinical program for the drug product matures, the CMC information should mature hand in hand. Have qualified potency assay(s) prior to conducting your pivotal study. Release testing alone is not sufficient.

Manufacturing 59

Manufacturing Clinic Provider IT 59

FDA Law Blog

JANUARY 4, 2023

The next town hall will focus on the clinical development of gene therapy products for rare diseases in February 2023. The Agency stated that the most common reason for a clinical hold of a Phase 1 study under an investigational new drug (IND) is related to safety. Common CMC Issues for Phase 1 IND Study. Comparability.

Manufacturing 59

Manufacturing Engineering Clinic Provider 59

FDA Law Blog

JANUARY 5, 2023

CDRH is building an extensive library of similar reports and white papers as it prepares its final guidance for medical device cybersecurity, scheduled to come out next Fall. Combination products are sharing the digital moment with those classified solely as medical devices.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 59

FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.

Supply Chain 59

Supply Chain Manufacturing Government Hospital 59

FDA Law Blog

JUNE 19, 2023

See , e.g. , ACLA White Paper on LDTs here. Would there be a new regulatory framework, as is proposed in VALID and outlined in FDA’s 2017 discussion paper (see our prior post here ), or something different? And regulating LDTs through guidance documents is vulnerable to legal challenge on procedural grounds.

IT 56

IT Management Clinic Medical 56