FDA Approves New Treatment for Adult Patients With Rare, Life-Threatening Blood Disease (PNH)

Posted by Tracy Hendershott on Dec 24, 2018 9:00:00 AM

At Eurofins BioPharma Services, we feel this FDA press release, as a Christmas gift that came early! After working on multiple protocols, across multiple clients, we couldn't be happier to see the continued evolution of treatment solutions for this rare disease (around 2 cases per million). Prior to the first treatment being released in 2007, life expectancy of patient diagnosed with PNH was only ten years, with poor quality of life throughout that time. With the significant resource dedication of years of effort and capital, our peers and colleagues throughout the clinical trial industry have allowed patients to have:

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Tags: FDA, Central Laboratory, Clinical Trial, PNH, New Treatment

FDA Guidance: Testicular Toxicity

Posted by Tracy Hendershott on Nov 26, 2018 9:29:00 AM

 

Testicular Toxicity

After being in the draft stages for approximately three years and continuing to receive industry feedback, the FDA CDER has just released final Guidance for Industry Title Testicular Toxicity: Evaluation During Drug Development in October 2018. There are numerous challenges with conducting multi-center clinical trials focusing on testicular toxicity and yet remaining within the realm of guidance from the FDA per their statement:

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Tags: FDA, Testicular Toxicity, Central Laboratory, Clinical Trial