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Are timely access and robust safety mutually exclusive?

pharmaphorum

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? And how can regulators balance timely access with robust safety? They found that the FDA approved 85 (95%) of the drugs before the EMA, with the latter clocking up a median delay of 241 (150-370) days. An abundance of caution?

Safety 94
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Navigating the Regulatory Environment of Pharmaceutical Marketing: Balancing Patient Safety and Industry Innovation

Pharma Marketing Network

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. The United States Food and Drug Administration (FDA) is the primary regulatory agency that oversees the approval, promotion, and advertising of drugs.

Safety 52
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Allotrope Medical announces FDA Safer Technologies Program (STeP) designation for their surgical device StimSit

Legacy MEDSearch

a company committed to advancing surgical efficiency and safety, announced that they have received Safer Technologies Program (STeP) designation from the FDA for their surgical device StimSite. “Surgeons are constantly learning new techniques, either robotics or laparoscopic, and safety is always front and center.

Medical 95
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Miracor Medical Announces FDA IDE Approval For PiCSO® Pivotal Study

Legacy MEDSearch

Miracor Medical SA (Miracor Medical) has announced the approval of an Investigational Device Exemption (IDE) from the FDA, enabling the company to initiate a pivotal study with its Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) technology. About Miracor Medical. Press Release by: Miracor Medical.

Medical 52
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MicroPort Navibot Receives 510(K) Clearance for its SkyWalker™ Robot-Assisted Platform for Orthopedic Applications

Legacy MEDSearch

MicroPort Navibot has received 510(K) clearance from the Food and Drug Administration (FDA) in the United States for the SkyWalker System, the company’s first robot-assisted platform for orthopedic applications. The SkyWalker System has the technical advantages of precise operation and efficient coordination, while prioritizing safety.

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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. European Network for Health Technology Assessment EMA. What are risk minimisation methods?

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The Caregiver Vertical: How Pharma Engages

Pharma Marketing Network

The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. February 18, 2020. What Can Pharma Do? Sunny White. Accessed March 12, 2022.

Pharma 98