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FDA Softens August 2025 NDSRI Deadline—Progress Reports Now Accepted

The FDA Law Blog

Snow — Recently, FDA announced a deadline shift, although the Agency did so quietly. Confirmatory testing remains due by August 1, 2025, but FDA has now acknowledged that full implementation of mitigation strategies—such as reformulation or the addition of new specifications—may take longer. By Charles D. What does this mean?

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More Uncertainty and Less Advice from FDA Means Companies will Need to Even More Carefully Chart their own Course to Achieve their Goals

The FDA Law Blog

Naomi Lowy, Principal Drug Regulatory Expert Trade and national press have reported that recent changes in FDA staffing levels have already led to slower responses to calls and emails. This coupled with more recent reports raised the specter of FDA falling short of user fee goals. Therein lies the opportunity.

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In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

The FDA Law Blog

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. How will the cuts at FDA impact inspections and enforcement? Dialogue is also key.

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Radical Transparency or Radical Redundancy? FDA Publishes 200+ Complete Response Letters, Most of Which Are Already Public

The FDA Law Blog

Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database. By Sarah Wicks & Michelle L.

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Knock, Knock – FDA Issues Guidance on Best Processes and Practices During BIMO Inspections

The FDA Law Blog

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

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What is the Pharma Marketing Network?

Pharma Marketing Network

Whether you’re a seasoned brand manager or a medical affairs communicator, chances are you’ve encountered the Network’s industry-shaping thought leadership or practical tools. It delivers insights through a mix of formats, including blog posts, webinars, research reports, interviews, and curated tools that reflect real-world applications.

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More on the Impact of the FDA RIFs: How Information Disclosure will Start FOIA-lling Behind

The FDA Law Blog

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. However, not all information contained in FDA records is disclosable. However, not all information contained in FDA records is disclosable.

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