Sound Physicians

APRIL 28, 2025

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. We take on significant financial risk across temp labor, clinical performance, clinician quality, payer collection, and fluctuation in volume.

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the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. Interpretation of Statutory Criteria Under the Final Guidance.

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.

Manufacturing 59

Manufacturing Clinic Provider IT 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. But a compromised device is a threat to patient safety, so that timeline that could change in the event of an adverse event that imperils consumer health.

Manufacturing 59

Manufacturing Patient-Centered Provider Telehealth 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

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. Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. The Notice of Proposed Rulemaking (NPRM) for LDTs is scheduled to be published in the Federal Register in August. Of course, the rulemaking process has its own uncertainties.

IT 56

IT Management Clinic Medical 56