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Expert Says FDA Under No Obligation to Educate Companies on Inspection Rights
The FDA has no obligation to educate companies about what is and isn’t fair game during an inspection and there is no equivalent of a “Miranda warning” that cops must give when detaining individuals, says inspections expert David Chesney, principal of DL Chesney Consulting.
The scope of any FDA inspection is governed by law, section 704 ...
Read MoreICER, Peterson Health Technology Institute Devise Assessment Framework for DHTs
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Read MoreCoherus Slapped With CRL for Neulasta Biosimilar BLA Due to Third-Party Filler
The trusted source for drug and device insights
Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments.
For decades, top drug and device manufacturers have relied on FDAnews’ insightful coverage with two of the industry’s most-trusted publications: Drug Industry Daily and Device Daily Bulletin Premium. These ...
Read MoreCybersecurity Final Guidance Details System Considerations for Premarket Submissions
The trusted source for drug and device insights
Compliance — and business success — are rooted in an understanding of the top pharma, medical device and regulatory developments.
For decades, top drug and device manufacturers have relied on FDAnews’ insightful coverage with two of the industry’s most-trusted publications: Drug Industry Daily and Device Daily Bulletin Premium. These ...
Read MoreHealthcare Marketing Trends for 2019 Emphasize Better Targeting with Cost-Effective Advantages
As healthcare marketers strive to keep pace with data technologies for better targeting and conversion, budgeting for 2019 becomes a formidable challenge. Questions about competitive advantages and cost-effectiveness drive conversations. Yet, the focus of forward-thinkers is shifting to better data for targeting faster and sooner in the engagement lifecycle.
“We are seeing a dramatic increase in ...
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