An Indiana Hoosiers fan, news junkie, health care journalist @PharmaPinkSheet, @IUBloomington alum, and soon a novelist. Opinions are my own.
Joined October 2008
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Derrick retweeted
Jun 10
CMS has created a new Office of Health Technology and Products: public-inspection.federalreg…
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Curious how integrating the patient voice in NPV decisions could work ... @PharmaPinkSheet: Timeline Clarity, Patient Voice Integration Needed For US FDA’s National Priority Voucher Program insights.citeline.com/pink-s…
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We're in a new orphan drug book, thanks in part to failure to renew (for a while) of the rare pediatric disease PRV program ... @PharmaPinkSheet: US FDA Regulatory Incentives Drive Boom In Rare Disease Applications insights.citeline.com/pink-s…
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Is the race to adjust supply chains back on? @PharmaPinkSheet @MaaishaO: Pentagon Chinese Company Designations Resurface Pharma Supply Chain Concerns insights.citeline.com/pink-s…
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Interesting job opening @US_FDA
Ready to lead? FDA's CDER is hiring a Supervisory Pharmaceutical Scientist — a senior role shaping drug quality policy & leading top scientific talent!
⏰ Deadline: 6/12/26
👉 Apply: usajobs.gov/job/871933600
#FDA #NowHiring #PharmScience #ScienceLeaders
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Fear of being the first ... @PharmaPinkSheet: CDER’s Innovative Trial Pilots Slow To Launch: Does Industry Need Greater Risk Intolerance? insights.citeline.com/pink-s…
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It may be difficult, but does anyone believe manufacturers won't at least try? @PharmaPinkSheet: MFN Deals Post-Trump: Launch Price Parity Would Be Hardest To Undo insights.citeline.com/pink-s…
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For your marijuana medicine radar. @US_FDA could get this application in 2028 ... @PharmaPinkSheet: Vertanical’s Cannabis Extract Exilby Could Break US FDA Regulatory Barriers For Botanical Products insights.citeline.com/pink-s…
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Make sure to like and subscribe ... @PharmaPinkSheet Pink Sheet Podcast: SCOTUS Rules On Generic Skinny Labels, US FDA’s NPV Faces Uncertain Future insights.citeline.com/pink-s…
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This meeting was awfully interesting to see disclosed. One of my stories for @PharmaPinkSheet: Replimune Met With US FDA, White House Officials Two Days Before RP1 Resubmission Announced insights.citeline.com/pink-s…
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Email and internet ads are not flying under the radar at @US_FDA ... @PharmaPinkSheet @PinkSheetSutter: Recent US FDA Ad/Promo Untitled Letters Citing More Email, Internet Issues, Less DTC TV Spots insights.citeline.com/pink-s…
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Not surprised at these comments given the issues with rare disease sponsors accessing accelerated approval.
@PharmaPinkSheet
@MaaishaO: Rare Disease Groups Tell US FDA Endpoint, Biomarker, Adcomm Reforms Needed insights.citeline.com/pink-s…
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AI is not conducting drug reviews quite yet ... the latest in @PharmaPinkSheet from @MaaishaO: US FDA Says AI Played Supporting, Summarizing Role In Fast BLA Review insights.citeline.com/pink-s…
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The generics industry is relieved this morning ... @PharmaPinkSheet @Genericbulletin: US Supreme Court Retains Skinny Labeling System, Backs Hikma Over Amarin insights.citeline.com/pink-s…
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Speaking of Makary-era reforms. This one could soon be opened for public comment. One of my stories for @PharmaPinkSheet: IND Reform Gains White House Review, Suggesting Progress Despite Makary’s Departure insights.citeline.com/pink-s…
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Interesting that preserving some of Makary's @US_FDA reforms is part of this ... @PharmaPinkSheet @MaaishaO: HHS Looks To Preserve Some Makary-Era Reforms As US FDA Commissioner Pick Looms insights.citeline.com/pink-s…
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I think the @US_FDA knows what the biggest problem wiht the NPV program is ... @PinkSheetSutter from @PharmaPinkSheet has the story: Stakeholders Want Clearer Eligibility Criteria For US FDA’s National Priority Voucher Program insights.citeline.com/pink-s…
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Sharpless could hit the ground running, since he ran the agency temporarily during the first Trump Admin, but Pops seems like he would generate a lot of concern.
Jun 4
News: A critic of RFK’s vaccine policies and a longtime pharma CEO are among the candidates Trump health officials are vetting for FDA commissioner, ppl familiar tell me and @owermohle.
The wide-ranging search is the latest sign of MAHA's loosening grip on Trump's health agenda.
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Skinny label system for generics survives...
First SCOTUS decision is Hikma Pharmaceuticals v. Amarin Pharma. Jackson has the unanimous opinion for the court reversing the Federal Circuit in the patent case. Amarin loses. supremecourt.gov/opinions/25…
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You don't see @US_FDA not being able to agree with a sponsor on safety labeling changes every day. @PharmaPinkSheet: US FDA Sends Takeda Rare Safety Update Order For Adzynma After Impasse On Language insights.citeline.com/pink-s…
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