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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog: Biosimilars

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. FD&C Act 501(j).

FDA
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Time for change: non-human primates in drug research

Drug Target Review

But growing ethical scrutiny, supply shortages, cost burdens, scientific innovation and regulatory shifts like the US Food and Drug Administration (FDA)’s new alternative methods roadmap are bringing the continued reliance on live NHPs into question, and opening the door to next-generation solutions that could eventually replace them altogether.

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Forging a Path Forward for Substance Abuse Potential Studies With the Cross-Company Abuse Liability Council By Beatrice Setnik, PhD

Alta Sciences

This was in 2006, at a time when the FDA guidances on these topics had not yet been published. Over time, this group of professionals evolved and grew, having regular stakeholder interactions with the FDA and Controlled Substances staff to discuss requirements for drug developers. corticosteroids, beta-blockers, antidepressants).

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Vamorolone

New Drug Approvals

Vamorolone was approved by the FDA in October 2023 for the management of DMD in patients ≥2 years of age. 2017, 82, 11961−11980. (77) 2017, 82,11961−11980. 19] The US Food and Drug Administration (FDA) approved vamorolone based on evidence from a single clinical trial of 121 boys with DMD who were 4 to <7 years of age.

FDA
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Biotech leader champions targeted cancer treatments and diversity

Drug Target Review

As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted small molecules aimed at revolutionising cancer treatment. So, with a huge amount of courage and commitment, I co-founded iOnctura in 2017.

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Gepirone

New Drug Approvals

4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5] 4] This came after the drug had been rejected by the Food and Drug Administration (FDA) three times over two decades due to insufficient evidence of effectiveness. [5]

FDA
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2025 Merkin Prize in Biomedical Technology awarded to pioneers of CAR T-cell therapy

Broad Institute

A similar CAR from another company, Kite Pharmaceuticals (now a Gilead company), was approved by the FDA in 2017 as the second commercial CAR T-cell therapy. After their clinical results, their technology was licensed to Juno Therapeutics (later acquired by Bristol Myers Squibb.)