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Why Is FDA Issuing Fewer Marketing Violation Letters?

Pharma Marketing Network

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled.

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FDA Awards HistoSonics Clearance of its First-of-a-Kind EdisonĀ® Histotripsy System

Legacy MEDSearch

Food and Drug Administration’s (FDA) De Novo Classification Request process, a rigorous pre-market review pathway for medical devices with no existing predicate. was achieved indicating that physicians can precisely target and destroy liver tissue and unresectable liver tumors.

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Considerations for Mobile Health Technology Developers: Part 1

pharmaphorum

Food and Drug Administration (FDA) regulation as a medical device. Kyle advises investors, academic medical centres, physician practices, and consultants on a range of business, legal, and regulatory issues affecting the telemedicine industry. If so, developers must develop and execute on a regulatory strategy.

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Gene therapy: a radical pharmaceutical revolution

European Pharmaceutical Review

In this Q&A, Karen Pinachyan, Head of Medical Affairs Europe at CSL Behring summarises key considerations for gene therapy drug development and the ideal approach for alleviating economic strain when advancing these modern treatments. The US Food and Drug Administration (FDA) requires a patient follow up period of at least 10-15 years.

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Private Patient Advocacy: The Medical Sales Repā€™s Role In The Nursing World With Antra Boyd And Karen DiMarco, Part 2

Evolve Your Success

You know when they are trying to push a drug and white-knuckling it. When a physician decides to use a robotic machine, that is not part of my decision-making process and the OR manager. You ask the hospital administrators to figure out the financial aspects of that side of it. What drugs are we using? Sales can be pushy.

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Developing point-of-care CAR T manufacturing

European Pharmaceutical Review

Chimeric antigen receptor (CAR) T cells are the first example of a “living drugā€. Being a cellular therapy that involves cell manipulation and molecular transfection ā€“ and above all, being a living drug ā€“ makes CAR T-cell therapy a somewhat challenging immunotherapy to manufacture inā€‘house.