Pharmacy Law Blog

MARCH 13, 2018

On December 4, 2017, a Florida federal judge refused to dismiss the federal government’s False Claims Act (FCA) suit against a compounding pharmacy. The federal judge refused the dismissal on the grounds that the government had sufficiently backed its allegations against both the company and its owner. December 4, 2017).

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Fraud Governance Licensing FDA 52

SQA

JUNE 10, 2021

183/2017, which provides the procedures to obtain the Brazilian Good Manufacturing Practices (BGMP) Certification for medical devices. Backgrounder – Government of Canada Investments in Biomanufacturing, Development of COVID-19 Vaccines and Therapeutics, and Research, 18 May 2021. Regulation for Software as a Medical Device.

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FDA COVID-19 COVID-19 Vaccine Compliance 52

SQA

MAY 24, 2023

MDCG 2023-3 , Questions and Answers on Vigilance Terms and Concepts as Outlined in the Regulation (EU) 2017/745 on Medical Devices, provides additional information on key vigilance terms. The name and address of manufacturers provided by the company on its establishment license application were not accurate.

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Bill of Health

APRIL 4, 2024

Beyond the health care sector-specific Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), this mix of AI & Data related regulatory requirements stems from a series of generalized, cross-sectoral EU laws of the last 5 years. The sectorialism of the U.S.

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FDA Regulatory Compliance Malpractice Health Insurance 282

Kaiser Health News

APRIL 6, 2022

About 30% of its funding comes from government grants and contracts. In presentations, they often share a 2017 study — conducted by an independent research institute at TROSA’s request — which found TROSA saves the state nearly $7.5 Only 12 facilities are licensed to prescribe buprenorphine.

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SQA

OCTOBER 18, 2023

The US FDA has already recognized the ability of 16 EU Member States to conduct GMP inspections of manufacturers of veterinary medicinal products. At the same time, the EU has recognized the US FDA as an equivalent authority to carry out these inspections.

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FDA Compliance Licensing World Health 40

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.

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