/u/bbyfog's posts in /r/RegulatoryClinWriting

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Did You Know? A Review of NDA or BLA by the FDA Costs Up to 4+ Million USD

7 upvotes

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Ecstasy for PTSD Treatment Study Left Out Suicidal Urges

5 upvotes

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Senate Bipartisan Bill, REMEDY Act, Aims to Address Pharmaceutical Patents-driven Monopolies

3 upvotes

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Enabling Platform Trials with Master Protocols: How EU-PEARL and TransCelerate BioPharma Created a Global Template

2 upvotes

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Excipient Safety in Pediatric Populations: FDA Guidance (or Lack of) and Upcoming FDA Webinar

2 upvotes

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How AI Medical Writing Tools are Reshaping MedComms Workflows

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Good Clinical Practice: UK MHRA Guidance on Compliance Inspection Program

2 upvotes

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[STAT News] Health care’s ‘Pepsi challenge’: Doctors’ offices are testing AI tools in head-to-head pilots

1 upvotes

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The Court of Justice of the EU rules on biocidal product advertising

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Should we extrapolate survival using ‘cure’ models?

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Title	Upvotes	Mark as read	Favorited	Rating	Add to a list
Did You Know? A Review of NDA or BLA by the FDA Costs Up to 4+ Million USD	7
Ecstasy for PTSD Treatment Study Left Out Suicidal Urges	5
Senate Bipartisan Bill, REMEDY Act, Aims to Address Pharmaceutical Patents-driven Monopolies	3
Enabling Platform Trials with Master Protocols: How EU-PEARL and TransCelerate BioPharma Created a Global Template	2
Excipient Safety in Pediatric Populations: FDA Guidance (or Lack of) and Upcoming FDA Webinar	2
How AI Medical Writing Tools are Reshaping MedComms Workflows	2
Good Clinical Practice: UK MHRA Guidance on Compliance Inspection Program	2
[STAT News] Health care’s ‘Pepsi challenge’: Doctors’ offices are testing AI tools in head-to-head pilots	1
The Court of Justice of the EU rules on biocidal product advertising	1
Should we extrapolate survival using ‘cure’ models?	1