The FDA Group's Insider Newsletter

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2026-10-30

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The FDA Group

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12 recent issues

• Covers: FDA draft guidances, quality audits, technology transfers, regulatory strategies, and compliance news across pharma and medtech.
• For: Regulatory affairs, quality assurance, and compliance professionals in FDA-regulated industries.
• Best for: Life science regulatory and quality professionals needing analysis on FDA compliance standards.
• Skip if: General consumers or healthcare professionals outside regulatory and manufacturing operations.

Start with

• Guidance Breakdown: eSTAR Is Coming for PMAs: Explains FDA draft guidance on electronic submission templates for PMA medical devices.
• 8 Lessons From a Site Quality Audit With Multiple Findings: Shares practical quality assurance takeaways from an audit identifying common manufacturing gaps.
• The Adoption Assumptions Hiding in Your Regulatory Strategy: Explores how medical device regulatory pathways impact downstream commercial market adoption.

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Summarised by AI from 12 recent issues. Audience size is not included. Prices are not included. Report a mistake.