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New FDA Initiative Reveals Common Reasons for Drug Application Rejection
New FDA Initiative Reveals Common Reasons for Drug Application Rejection

July 11th 2025

By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.

Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment
Obsolete Trial Marketing Guidelines and Missing Processes Hurt Patient Enrollment

July 8th 2025

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Tokenization: The Unsexy Plumbing of Clinical Research

June 24th 2025

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FDA to Launch National Priority Voucher Program to Speed Drug Reviews for Critical Therapies

June 18th 2025

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Clinical Trial Monitoring: Should Randomization Be Included?

May 28th 2025

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