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

Pharma Marketing Network

However, pharmaceutical marketing is also regulated by several agencies to ensure that patients are not exposed to false or misleading information. In this article, we will explore the regulatory environment of pharmaceutical marketing and how companies are navigating it to balance patient safety and industry innovation.

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Pharmacovigilance deep dive: risk minimisation measures

European Pharmaceutical Review

To ensure the safety of medicines post-regulatory approval, a risk management plan (RMP) is established. As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. What are risk minimisation methods?

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Getting ahead of regulatory changes around PFAS in pharmaceutical packaging

Clarivate

Over the past few years nitrosamines and nitrosamine impurities have been increasingly gaining the reputation of being high-risk containments in the food industry. The food sector has already initiated the publication of preliminary regulations aimed at restricting PFAS in packaging. [3].

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

Nixon Gwilt Law

The rule aims to regulate and enhance the transparency, effectiveness, and safety of predictive DSIs used in healthcare settings, ensuring that these technologies are developed and managed responsibly. Effective: Ensures that DSIs achieve their intended outcomes, improving clinical decision-making and patient care.

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Ancora Heart Receives Breakthrough Device Designation from FDA for the AccuCinch® Ventricular Restoration System

Legacy MEDSearch

Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the AccuCinch ® Ventricular Restoration System. This program is designed to ensure patients and healthcare providers have more timely access to these medical devices. Ancora Heart , Inc., An estimated 6.5 million U.S. An estimated 6.5

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US legislative update: takeaways for European pharma

European Pharmaceutical Review

In the US, members of the public can request, through a Citizen Petition, that the US Food and Drug Administration (FDA) “take or refrain from taking” various administrative actions, including denying approval of generic and biosimilar drug applications. Citizen Petitions before the FDA. Measuring and rating biosimilar access. Conclusion.

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Preparing for stricter standards on substances of human origin

European Pharmaceutical Review

Background on BCT legislation in the EU Every year EU patients are treated with 25 million blood transfusions, a million cycles of medically assisted reproduction, over 35,000 transplants of stem cells and hundreds of thousands of replacement tissues.

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