Michael McCaughan on Muck Rack

Michael McCaughan

As seen in: Scrip, The Pink Sheet, The Irish Times, Citeline, Generics Bulletin, HBW Insight, Medtech Insight, Friends of Cancer Research, Source Magazine, The Pink Sheet Podcast, Win the Inbox Podcast
Founding Member, Prevision Policy LLC Business Implications of FDA and CMS Policy; Policy Implications of Biopharma Business
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Articles

ODAC After Pazdur: US FDA Oncology Reviews May Become Less Predictable

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By Michael McCaughan
| The Pink Sheet Verified
The first Oncologic Drugs Advisory Committee since longtime oncology chief Richard Pazdur’s retirement suggests a lot more drama is possible without him steering the discussion. ODAC may be less predictable without Richard Pazdur at the FDA. (Shutterstock) Key Takeaways Without Richard Pazdur steering the conversation, ODAC meetings may be less predictable going forward. Oncologic Drugs Advisory Committee meetings could be a lot less predictable now that Richard Pazdur has left the US Food...
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Pharma’s US FDA Takeover? Ex-CDER Director Wonders About Changes

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By Michael McCaughan
| The Pink Sheet Verified
Former Acting CDER Director Tracy Beth Høeg disputed the narratives about the recent FDA management changes during a podcast appearance and warned of pharmaceutical industry influence at the agency. Former Acting CDER Director Tracy Beth Høeg appeared on The Doctor's Lounge podast and explained the circumstances of her firing from the FDA.
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Riddle Of The Sphinx: Reading Into US FDA’s Striking Silence At NPV Hearing

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By Michael McCaughan
| The Pink Sheet Verified
FDA officials gave no signal of their feelings on the future of the National Priority Voucher program during a June 4 hearing. They essentially said nothing at all. Could stakeholders take anything away from the FDA's silence at the NPV public hearing? (Shutterstock) Key Takeaways Attendees at the FDA’s NPV public hearing that may have been hoping to hear clues about the future of the program likely were disappointed.
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