Drug Discovery World

FEBRUARY 1, 2023

There are more than 1300 clinical trials on cannabis underway and companies focused on the cultivation and manufacturing of cannabis are also educating doctors and patients about its potential pharmaceutical use. Germany only has three licenses, and the current facilities are a small fraction of total sales.

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Clinical Trials Trials Pharmaceutical Companies Doctors 130

Perficient: Drug Development

JANUARY 24, 2024

Before I begin, I just want to caveat everything with the fact that HIPAA is a complex regulation open to interpretation, and in the end your legal and compliance teams need to be comfortable with how you handle data and the risk associated with those methods. The other part of the definition is what constitutes “health information.”

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Licensing Licensing Production Regulations 96

Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Laboratories FDA Regulations Licensing 81

Codon

JULY 14, 2024

While blood doesn’t fit neatly into the various definitions of an organ , it still comprises a discrete system with specific functions. It is licensed in Russia and South Africa and is included in a few compassionate use programs across the globe, meaning it can be used clinically in cases where patients have few remaining options.

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Production Clinical Trials Trials Therapies 133

Agency IQ

MAY 28, 2024

Companies are paying for performance here, and it’s reasonable for them to expect performance” remarked Burgess, “And then we hear other discussions that the FDA wants to vastly expand its authority into licensing laboratory developed tests. If you don’t have the staff to do this, how are you going to have the staff to do that?”

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The Pharma Data

MAY 13, 2021

Description: How A Handsome Doctor From Texas Saved My Life. I could hear doctors and nurses speaking in hushed tones…. I gave up carbs, fats, alcohol, meat – just as the doctor ordered…. My dear old doctor told me that hormone testing is expensive and unnecessary…. My doctor said it was all simple math….

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