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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 sets out its thinking on protecting children in clinical trials

pharmaphorum

The FDA has published draft guidance giving its position on the ethical reasons for including children in clinical trials, and protecting them from harm. ” The post FDA sets out its thinking on protecting children in clinical trials appeared first on.

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How clinical outcome assessments can help us understand the patient experience

Clarivate

Clinical outcome assessments can take years to generate but may pay big dividends in patient-focused drug development, centering the patient experience and potentially bolstering a product’s case with regulators and payers. A clinical outcome assessment is a measure that describes or reflects how a patient feels, functions or survives.

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US FDA grants Fast Track status for UNION’s oral orismilast to treat HS

Pharmaceutical Technology

The US Food and Drug Administration (FDA) has granted Fast Track designation for UNION therapeutics’ oral orismilast to treat moderate-to-severe hidradenitis suppurativa (HS). The post US FDA grants Fast Track status for UNION’s oral orismilast to treat HS appeared first on Pharmaceutical Technology.

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Biogen is in deep trouble and may not survive

World of DTC Marketing

Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. This approval was NOT about patients; it was about the profits of a pharma company in quicksand and sinking fast. That meeting was reportedly followed by a formal meeting between Biogen and FDA in June 2019.

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Navigating the World of Medical Device Equipment Sales: Tips for Success

Rep-Lite

Sales representatives play a crucial role in connecting healthcare facilities with innovative technologies that improve patient care. While the rewards can be significant, carving a successful path in this field requires a unique blend of technical knowledge, interpersonal skills, and a commitment to ethical practices.

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Sorry.COVID treatment data may not be reliable

World of DTC Marketing

That should tell you all you need to know about how bad things are with the FDA and trust in drug approvals. I gained an understanding of the need to follow FDA guidelines and let as many people as possible evaluate the data. For the first time, I am now in fear of FDA drug approvals. Dr. Stephen Hahn, the F.D.A.’s