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Future Trends and Regulatory Challenges in Pharma

Dot Compliance

The race to develop a COVID-19 vaccine highlighted the power of artificial intelligence (AI) and machine learning (ML) as Johnson & Johnson, Moderna and Pfizer employed these technologies to swiftly get their vaccines to market. The next evolution is for companies to implement Industry 4.0 References. References.

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SQA Regulatory Surveillance Summary 4 | Monthly Update 2021

SQA

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. Regularization of orthopedic implants.

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Hall Render’s Health Provider News – January 28, 2022

Hall Render

COVID-positive employees returning to work: 2 CEOs share their protocols. FDA halts use of antibody drugs that don’t work vs. omicron. Where Hospital Price Transparency Compliance Is Lagging. With a vaccine mandate looming, nursing homes face more staffing problems. Oklahoma health agency modifying COVID-19 testing hours.

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The BFDs – The Ten Best Prescription Drug/Medical Device Decisions of 2023

Drug & Device Law

Since the FDA requires pre-approval of any warnings about off-label uses, preemption at some point should have been pre-ordained under the Mensing ( 2011+1 ) independence principle, but off-label use did not really figure in Zofran ’s analysis. The FDA’s five reviews of teratogenic risk all came to the same conclusion.

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