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Medicinal cannabis: Why more clinical trials and better access is needed

Drug Discovery World

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. Meanwhile, Spain has the makings of a potentially strong supplier once regulations become clearer.

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Women in STEM with Dr Catherine Sheehan

Drug Target Review

The regulatory science project I pursued for my first master’s degree titled, “21st Century Pharmaceutical Excipients: Consequences of a Global Supply Chain and Lack of Excipient Regulations” aimed to draw attention to the risks created by the lack of sufficient oversight of the pharmaceutical excipient supply chain.

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Healthcare, HIPAA, Sitecore and BAAs

Perficient: Drug Development

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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Analysis Chemical Thank You What’s going on in the world of PFAS – early 2024 edition

Agency IQ

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. An AgencyIQ explainer on the EPA’s definition of PFAS may be reviewed here.] since June 21, 2006.

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Who are the AACR Scientific Achievement Award winners?

Drug Discovery World

as a master regulator of prostate differentiation and cancer initiation and progression, for generating unique and reliable murine bladder and prostate cancer models, and for steadfast commitment to serving as a leader, mentor, and supporter of women in cancer research. Doctors said not to worry.

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Analysis Life Sciences Thank You FDA’s nonprescription advisors find no efficacy for phenylephrine

Agency IQ

BY AMANDA CONTI SEP 13, 2023 1:58 PM CDT Quick background on nonprescription drug regulation Nonprescription drugs, also known as over-the-counter (OTC) drugs, are regulated differently than traditional prescription drugs. The FDA will follow these procedures for both agency-initiated operations (e.g.,

Science 40
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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law Blog: Biosimilars

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.