HIT Consultant

MAY 31, 2023

Common industry practice today allows small groups of large, powerful pharmaceutical manufacturers to drive new drugs through regulatory processes, acting as the gatekeepers to achieve FDA approval. A study on hospital market concentration found between 2007 and 2017, one single hospital system was serving 19% of the market — 11.2

Pharmaceutical Industry 96

Pharmaceutical Industry Hospitals Telemedicine FDA 96

American Medical Compliance

OCTOBER 17, 2023

Get Certified American Medical Compliance (AMC) is a leader in the industry for compliance, Billing and HR solutions. To become certified, please visit us at: American Medical Compliance (AMC). Buy Course Today The post ISO 22000 Standard for Food Safety Management appeared first on American Medical Compliance.

FDA 52

FDA Compliance Regulations Compliance 52

SQA

AUGUST 8, 2023

TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. Although this Toolkit provides PCPCs current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. TR 43 applies solely to empty glass containers.

FDA 40

FDA Compliance COVID-19 World Health 40

SQA

AUGUST 8, 2023

TR 43 was originally published in 2007 and revised in 2013 to address industry feedback. Although this Toolkit provides PCPC’s current thinking on MoCRA, companies should be mindful that MoCRA represents meaningful new authorities that FDA has yet to interpret and apply. TR 43 applies solely to empty glass containers.

FDA 40

FDA Compliance COVID-19 World Health 40

Health Law Advisor

FEBRUARY 1, 2022

The United States Food and Drug Administration (FDA) for many years has been trying to increase the participation of minorities in clinical trials to help ensure that regulated products are tested and labeled in an appropriate cross-section of Americans. National Library of Medicine, with support from FDA.

FDA 52

FDA Compliance 52

HIT Consultant

AUGUST 18, 2021

Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA. Food and Drug Administration (FDA), along with greater flexibility around mandates on alternatives to traditional clinical information. These approaches have combined to help accelerate FDA review and study commencement timelines to as low as 30 days.

COVID-19 52

COVID-19 COVID-19 Vaccine Pharmaceutical Industry FDA 52

Drug & Device Law

JANUARY 25, 2024

142 (2007), mere regulation of the product or conduct at issue—the medical walker is a non-prescription, Class I medical device with general controls only—is not a basis for removal under this statute. In those cases , the question is often whether the claims put FDA compliance at issue or whether the defenses do.

Medicare 52

Medicare Medicare FDA Regulatory Compliance 52