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US FDA Explores Pandemic Inspection Alternatives, Post-Pandemic Strategies

 
• By Bowman Cox

Agency's Janet Woodcock  and Judy McMeekin say the FDA is looking at options like livestream plant videos while preparing to address backlog after inspections can resume.

Inspector removing a white card with Inspector sign from the inner pocket of his jacket. Conceptual of health, business or other inspection coming over unannounced.
what will happen when shoe-leather options return

The US Food and Drug Administration continues to study new approaches for drug manufacturing oversight during the COVID-19 pandemic while also preparing for a challenging post-pandemic period, acting commissioner Janet Woodcock and associate commissioner for regulatory affairs Judy McMeekin said in an 18 March “FDA Voices” post.

The agency is studying how to make use of new facility oversight technologies and tools like remote video livestreams of plant operations, teleconferences and screen sharing – as well as...

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US FDA’s Familiar Drug Pricing To-Do List

 
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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
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Sarfez Pharma’s Promotional Claims For Diuretic Soaanz Draw US FDA Warning Letter

 
• By Sue Sutter

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US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
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Industry Leaders Grapple With Trump’s Most Favored Nation Pricing Plan

 
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