Hall Render

JANUARY 3, 2024

Liza Brooks is based in the firm’s Detroit office and focuses her practice on supply chain operations, health information technology and clinical research compliance. from the University of Dayton School of Law in 2014. office and helps clients navigate the complex and ever-changing landscape of FDA regulation.

Fraud 40

Fraud Hospitals Compliance FDA 40

SQA

SEPTEMBER 2, 2022

ISPE Good Practice Guide: Critical Utilities GMP Compliance. United States Food and Drug Administration (FDA) – Regulations and Guidances. FDA Proposes Benefit-Risk Considerations for Product Quality Assessments, 20 June 2022. ISPE Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems .

FDA 91

FDA COVID-19 Nursing Homes Compliance 91

SQA

JULY 8, 2022

V60 and V60 Plus devices are designed for in-hospital use. Philips has no permanent solution to correct this issue, so the MHRA is issuing this alert to help hospitals manage the risk. 536/2014 on Clinical Trials, which will replace EU Annex 13. 536/2014 on Clinical Trials replacing EU Annex 13.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

Health Law Advisor

AUGUST 10, 2023

But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI? FDA has been regulating machine learning algorithms used in a clinical context for decades. It’s important to understand that FDA regulation isn’t punitive in the sense that it’s only intended to apply to bad people.

FDA 98

FDA Licensing Hospitals Medicaid 98

SQA

AUGUST 2, 2021

ISO 18082:2014, Anesthetic and respiratory equipment – Dimensions of non-interchangeable screw-threaded (NIST) low pressure connectors for medical gases. The following two PIC/S guidance documents have been revised: PE 005-4: PIC/S Good Practice Guidelines for Blood Establishments and Hospital Blood Banks. b) and 320.31(d)(3)).

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

FEBRUARY 26, 2024

The reported irregularities and the manufacturing conditions of the products, that is, compliance with Good Manufacturing Practices, were verified on the spot. The glossary was originally published in 2014 and has been used to define excipient terms and acronyms commonly found in IPEC guides.

FDA 52

FDA Compliance COVID-19 Public Health 52

Drug & Device Law

JANUARY 15, 2024

That is significant because, unlike (now) every other state in the country, since 1987 Pennsylvania precedent prohibited defendants from introducing evidence of their compliance with government and/or industry standards (“standards compliance” or “compliance” evidence, for short) in strict liability design defect cases – generally.

Compliance 52

Compliance FDA Governance State Policy 52