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Navigating the Regulatory Environment of Pharmaceutical Marketing: Balancing Patient Safety and Industry Innovation

Pharma Marketing Network

Pharmaceutical marketing is a critical aspect of the industry, as it helps in spreading awareness about the benefits and potential side effects of different drugs. First, it is important to understand the different regulatory agencies that govern pharmaceutical marketing.

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Pharma Marketing: A Guide for Healthcare Companies

Pharma Marketing Network

Pharmaceutical marketing is the process of communicating the benefits of a pharmaceutical product to potential patients and healthcare providers. This type of advertising is often used to raise awareness of a new drug or to promote a new indication for an existing drug.

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Economics and risks of FDA’s Quality management maturity rating programme

European Pharmaceutical Review

The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) through the Office of Pharmaceutical Quality in 2021 embarked on an initiative to develop a framework for establishing a pharmaceutical manufacturing site quality rating system, the Quality management maturity (QMM) programme.

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What Pear Therapeutics’ Bankruptcy Has Left the DTX Industry to Ponder

MedCity News

One of the fastest-growing frontiers of healthcare is Digital Therapeutics (DTx), which utilizes clinically tested software to prevent, treat, and manage a growing range of medical conditions. During Covid-19, governing agencies loosened regulatory requirements and increased incentives for DTx.

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How do Healthcare AI Developers (and Buyers) Stay Ahead of the Regulatory Curve?

Nixon Gwilt Law

HIPAA is the pantheon of healthcare data privacy regulation in the U.S. Its three separate Rules (Security, Privacy, and Breach) impose a variety of security controls, documentation, governance, and notice requirements on custodians of protected health information (PHI). When does it apply? HTI-1 What is it and when does it apply?

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Diversity and inclusion in oncology clinical trials

Clarify Health

Food and Drug Administration (FDA) released guidance entitled, Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry. To advance equity in clinical research, the U.S. Clarify launched its real-world evidence on health disparities in 2021.

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Pharma dodges a bullet, for now

World of DTC Marketing

Medicare’s innovation center may be the best avenue for lowering drug costs if provisions empowering government price negotiation don’t’ make it into a sweeping domestic spending package. For now, drug companies are free to overcharge Medicare for prescription drugs.