Derrick Gingery

The latest @PharmaPinkSheet podcast is posted! Listen as @PinkSheetSutter, @PinkSheetHobbs and I discuss Vinay Prasad's appointment as @US_FDA CBER director and the guidance development slowdown. NO PAYWALL! https://t.co/sqBZfyuh3u

This may not seem like a big deal, but for @US_FDA it is extremely important for application review, compliance and other activities...Our @PinkSheetSutter reporting that library resources are being restored: https://t.co/QsuDFIh0cZ

RT @SarahKarlin: This story is now free to read. Since I wrote Tuesday, Prasad has twice said he understands need for regulatory flexibili…

And if that wasn't enough, Most Favored Nation pricing is coming back ... @PharmaPinkSheet: Most Favored Nation Pricing Policy Floated In Medicaid, Coming Back To Medicare? https://t.co/qzxeAj7m7T

This @PharmaPinkSheet adcomm policy story from @PinkSheetSutter with a contribution from me discusses the cuts to conflict of interest screening for committee members: US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting https://t.co/k1MwbfeUz6

The @PharmaPinkSheet has a couple stories on @US_FDA adcomm policy. This one covers the industry rep "ban." @RPMReportMike: US FDA Advisory Committee Misperceptions Abound … At HHS https://t.co/Qt7NWtQ0lT

RT @SarahKarlin: inconsistent messaging. RFK towards end of this clip suggests placebo controlled rcts for all new medicines.

RT @PinkSheetSutter: "I am very concerned," Makary writes. "Historically, there has been a delayed recognition of fast-growing trends, such…

Interesting conversation among @US_FDA officials here...

U.S. FDA @US_FDA

FDA Commissioner Makary sits down for a conversation with the newly appointed director of the Center for Biologics Evaluation and Research (CBER) Dr. Vinayak “Vinay” Kashyap Prasad and Sanjula Jain-Nagpal, Associate Director of Policy & Research Strategy, Office of the https://t.co/6KWH8CJhkk

To say the week of May 20 is going to be busy for @US_FDA regulatory reporters is an understatement. Our @PinkSheetSutter has the info in the @PharmaPinkSheet: FDA Adcomms Are Back: Four Cancer Drugs, COVID-19 Vaccine Formulations To Get Reviews https://t.co/MMDBCgoCgG

One of my stories. Wondering why some guidances aren't being published? The answer is here in @PharmaPinkSheet: US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped https://t.co/wL7Ak6RBcr

Industry says incentives, not tariffs, are better when trying to increase domestic drug production ... @PharmaPinkSheet @PharmaScrip: Pharma Industry Argues Tax, Other Incentives Better Than Tariffs https://t.co/eq4iqzNk1g

A perspective from India officials on the @US_FDA's call to increase surprise foreign inspections from @PharmaPinkSheet: US FDA’s Expanded Surprise Foreign Inspections: Impact And Enforcement Hoops https://t.co/L4pSJlct96

The @US_FDA sets July 14 as the public meeting to kick-off PDUFA VIII negotiations and asks for groups to participate in stakeholder update mtgs. https://t.co/KT4tOtiTMA

RT @PharmaPinkSheet: US FDA Guidance Roadblock: Writing Continues, But Publication Has Slowed Or Stopped https://t.co/EwjYW99Y3b #PinkSheet…

Curious to see how the AI portion of the review will be handled in review docs. Will there be an explanation of the AI model used and assurances that the results it gave are accurate?

Dr. Martin Makary @DrMakaryFDA

We at the FDA now have to ask big questions that we’ve never asked before. Why does it take over 10 years for a new drug to come to market? Why are we not modernized with AI and other things? We’ve just completed our first AI-assisted scientific review for a product and that’s

Wondering how this program is working after the staff cuts ... @PharmaPinkSheet: Sponsors Like START Rare Disease Pilot, Will Prasad Maintain Its Momentum? https://t.co/JKDEEtCqVa