Innovaare Compliance

JANUARY 15, 2024

6] A compound drug not approved by the FDA under a New Drug Application or Biological License Application does not meet the definition of an applicable drug and will not be eligible for Part D. With a team of compliance specialists, Inovaare provides in-depth technical expertise and compliance preparedness evaluation, guidance, and support.

Medicare 52

Medicare Medicare Compliance FDA 52

SQA

FEBRUARY 15, 2023

Of interest is a reference to the FDA’s draft document “Computer Software Assurance for Production and Quality System Software,” which was recently published on 13 September 2022. PCPC looks forward to working with the FDA and key stakeholders to implement this important legislation.

US Department of Health and Human Services 40

US Department of Health and Human Services FDA COVID-19 World Health 40

Hall Render

NOVEMBER 30, 2023

On September 29, 2023, the Food and Drug Administration (“FDA”) announced the issuance of a Notice of Proposed Rulemaking (the “Proposed Rule”) to expand the FDA’s regulatory scope over in vitro diagnostics products (“IVDs”) to specifically address Laboratory Developed Tests (“LDTs”). Part 820 ), unless they fall under an exemption.

FDA 40

FDA Public Health Compliance Hospitals 40

Healthcare IT Today

JANUARY 19, 2024

are expected to reach $6 trillion by 2027, cost containment and the push to increased decentralization of care will be a top healthcare priority in 2024. Sandeep Akkaraju, CEO & Co-Founder at Exo As healthcare costs in the U.S.

Hospitals 91

Hospitals Governance FDA Licensing 91

Dot Compliance

FEBRUARY 1, 2022

Food and Drug Administration (FDA) recently issued pharma industry guidance documents that will impact how companies collect, manage and submit quality data to the agency. The post Future Trends and Regulatory Challenges in Pharma appeared first on Dot Compliance. Data in the regulatory spotlight. References. References. References.

FDA 52

FDA COVID-19 Vaccine Pharmaceutical Industry COVID-19 52

SQA

MAY 24, 2023

The vote occurred on 16 February 2023 following a plenary meeting of the European Parliament, and represents a significant step towards a formal extension of MDR and IVDR compliance deadlines for some device manufacturers.

FDA 40

FDA Licensing Governance Compliance 40

Health Law Advisor

MAY 20, 2022

Since the passage of the Medical Device Amendments of 1976, FDA has regulated in vitro diagnostic (IVD) tests as medical devices, subject to a full suite of FDA requirements. FDA’s approach changed in 2014 when it issued draft guidance describing a plan to phase out FDA enforcement discretion and regulate LDTs.

FDA 52

FDA COVID-19 Compliance Governance 52