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Regulatory Sciences

Navigating FDA Layoffs: How Policy Layoffs May Impact Generic Drug Development

Layoffs at the Office of Generic Drug Policy Could Slow Development—but Strategic Guidance Can Help Sponsors Stay on Track The FDA has recently undergone a wave of layoffs that are beginning to...

Regulatory Sciences

Navigating FDA Layoffs: OPDP Cuts and the Rising Stakes of Ad Compliance

The Importance of Compliance in Prescription Drug Advertising Amid Cuts to the Office of Prescription Drug Promotion The Office of Prescription Drug Promotion (OPDP), a key Office of the U.S. Food...

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Regulatory Sciences

Navigating a Shifting Regulatory Landscape: The Impact of FDA Layoffs on Medical Device Developers

On Thursday, March 27, 2025, HHS announced that they would be conducting a reduction in force impacting nearly 3,500 full time FDA employees – nearly 20% of the Agency’s entire workforce. This comes...

Clinical Research Solutions

USP and FDA Propose Updates to Good Storage and Distribution Practices

Updates have been announced by FDA and for USP <1079>. In this blog we cover these changes. USP USP <1079> has a series of chapters on Good Storage and Distribution Practices. Chapter <1079> applies...

Clinical Research Solutions

What Should Be on Your Clinical Trial Investigator Site Audit Checklist?

What Should Be on Your Clinical Trial Investigator Site Audit Checklist?: You live and operate in a regulated industry. Obviously, it’s crucial that you stay in compliance during your clinical...