Derrick

Heading on spring break? While you're waiting in line to get through airport security, check out the latest @PharmaPinkSheet podcast! @PinkSheetSutter, @PinkSheetHobbs and I discuss @DrMakaryFDA's first year as FDA Commissioner. NO PAYWALL! insights.citeline.com/pink-sheet/pod…

(3/3) And here's a comprehensive timeline of events during @DrMakaryFDA's first year as @FDA commissioner @PharmaPinkSheet: insights.citeline.com/pink-sheet/age…

(2/3) @DrMakaryFDA also answered several of our questions, which we made into this story @PharmaPinkSheet: insights.citeline.com/pink-sheet/age…

(1/3) The @PharmaPinkSheet package on @FDA Commissioner @DrMakaryFDA's first year is out! The great @PinkSheetSutter and colleagues did an excellent job recapping everything that's happened and looking forward. Here's the main story: insights.citeline.com/pink-sheet/age…

More user fee cost debates ... @PharmaPinkSheet: GDUFA IV: US FDA Worries About Revenue Shortfalls, Industry Does Not insights.citeline.com/pink-sheet/pat…

For our clinical trial radar ... @PharmaPinkSheet: US FDA Allergenics Staff Sees Single-Trial ‘Default’ As Helpful insights.citeline.com/pink-sheet/pat…

Rumors of FDA's regulatory flexibility departing may have been premature ... @PharmaPinkSheet: Denali’s Avlayah Offers Broader Treatment Of Hunter Syndrome, Evidence Of US FDA Flexibility insights.citeline.com/pink-sheet/pro…

An interesting development post-FDA layoffs ... Some PDUFA spending still went up. One of my @PharmaPinkSheet stories: US FDA Layoffs Did Not Curtail Some PDUFA Spending insights.citeline.com/pink-sheet/pat…

For your user fee reauthorization legislation trackers. This issue could be included ... @PharmaPinkSheet @RPMReportMike: China’s Threat To US Rx Sector Unifying Capitol Hill insights.citeline.com/pink-sheet/leg…

A warning letter after several untitled letters ... @PharmaPinkSheet: Soon-Shiong’s Statements Overstated Efficacy Of Immunity Bio’s Anktiva, US FDA Says insights.citeline.com/pink-sheet/com…

For your patent and generic drugs radar ... @PharmaPinkSheet: Ascent’s US Myrbetriq Challenge Fails, Court Upholds Astellas Mirabegron Patents insights.citeline.com/pink-sheet/bio…

If you aren't following this and you are in the drug manufacturing space, you should be. One of my stories for @PharmaPinkSheet: GDUFA IV: Industry Questions Proposed Four-Month pOAI Goal Extension insights.citeline.com/pink-sheet/pat…

The @PharmaPinkSheet's closer look at the 483 response guidance from @PinkSheetSutter: US FDA Seeks Higher Quality Responses To Form 483 Inspection Findings insights.citeline.com/pink-sheet/com…

FDA issued a warning letter to $IBRX about "false and misleading" statements regarding Anktiva made by @DrPatrick on the Sean Spicer TV show. fda.gov/inspections-co… h/t @AlecGaffney for spotting first.

ICYMI on Friday @PharmaPinkSheet: Pink Sheet Podcast: ACIP Next Steps After Judge Stops Work, Potential Opioid Disposal Changes insights.citeline.com/pink-sheet/pod…

For those of you keeping track of the user fee calendar, this date is important. One of my stories for @PharmaPinkSheet: BsUFA IV Talks Scheduled For Early April, Is ‘America First’ Coming? insights.citeline.com/pink-sheet/pat…

I think this meeting and this docket are going to be popular. Lot of opinions and questions about CNPV ... @PharmaPinkSheet: National Priority Vouchers: Amid Scrutiny, US FDA Sets Meeting On Makary’s Signature Program insights.citeline.com/pink-sheet/pat…

FDA is officially looking to hire a new Director of its Center for Biologics Evaluation and Research (CBER), and now you can see the full list of qualifications. Would replace the outgoing director, Vinay Prasad, who is leaving at the end of April. The agency is also looking for a second Deputy Director of CBER : (usajobs.gov/job/860827200) We haven't yet seen FDA post about hiring a new Chief Scientific/Medical Officer, which is the other position held by Prasad.

@CitizenCohn Good thing the bank was open.

Holy cow, that end of regulation in Kentucky-Santa Clara

The latest @PharmaPinkSheet podcast is posted! Get our take on the ACIP court case and resulting drama, as well as an under-the-radar opioid issue: Pink Sheet Podcast: ACIP Next Steps After Judge Stops Work, Potential Opioid Disposal Changes insights.citeline.com/pink-sheet/pod…