@dgingery

An Indiana Hoosiers fan, news junkie, health care journalist @PharmaPinkSheet, @IUBloomington alum, and soon a novelist. Opinions are my own.

 Maryland
derrickgingery.blogspot.com
Joined October 2008
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28Media
Check out the @PharmaPinkSheet's @PinkSheetSutter's interview with the OCE director: US FDA Oncology Chief Angelo De Claro Continues Patient-Centered Focus As OCE Nears 10th Year insights.citeline.com/pink-s…

US FDA Oncology Chief Angelo De Claro Continues Patient-Centered Focus As Center Nears 10th Year

In an interview with the Pink Sheet, de Claro said he plans to continue refining programs on review efficiency and innovation, regulatory science, and external engagement, and said the speedy review...

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Love that the word "delinking" is making a comeback @PharmaPinkSheet ... Medicare Part D PBM ‘Delinking’ Exclusion for Bona Fide Service Fees Builds On Part B Policies insights.citeline.com/pink-s…

Medicare Part D PBM ‘Delinking’ Exclusion for Bona Fide Service Fees Builds On Part B Policies

CMS' approach to defining bona fide fees' fair market value "largely aligns" with 2026 Medicare Physician Fee Schedule proposed rule.

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For your real world evidence radar ... @PharmaPinkSheet: Living Real-World Evidence Libraries Need Examples Of Failure Too insights.citeline.com/pink-s…

Living Real-World Evidence Libraries Need Examples Of Failure Too

Speakers at the DIA Real World Evidence conference urged sponsors and researchers to share clinical trial failures and successes in open “living libraries,” arguing negative and positive examples are...

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Also interesting given the ongoing focus on AI and other technology updates @FDA ... @PharmaPinkSheet: Digital Endpoints: US FDA Says Start With Outcomes, Not Tech insights.citeline.com/pink-s…

Digital Endpoints: US FDA Says Start With Outcomes, Not Tech

A white paper on “Digitally Derived Measures” stresses that the process of incorporating them into clinical trials must start with outcomes that matter to patients, not the digital tools’ capabilit...

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As more drugs have apps and other software associated with them, this guidance update I wrote about for @PharmaPinkSheet will gain more attention: US FDA Drug Use Software Guidance Wants Labeling To Clearly State When It Is Optional insights.citeline.com/pink-s…

US FDA Drug Use Software Guidance Wants Labeling To Clearly State When It Is Optional

New final guidance on prescription drug use-related software makes clear that without evidence of improved clinical outcomes, labeling must state the software is not necessary for safe and effective...

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More info on the reorganization at the @FDA from @PharmaPinkSheet's @MaaishaO: US FDA Drops CIO, But Keeps Sanjay Sahoo As Acting Head Of New Mission IT Office insights.citeline.com/pink-s…

US FDA Drops CIO, But Keeps Sanjay Sahoo As Acting Head Of New Mission IT Office

The FDA retired the Chief Information Officer title, but Sanjay Sahoo moved to temporarily lead the new Office of Mission Information Technology Services as the agency’s technology push shifts to...

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Make sure to check this out too ... @PharmaPinkSheet: Pink Sheet Podcast: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework insights.citeline.com/pink-s…

Pink Sheet Podcast: What Drove US FDA Generics Chief To Step Down And New Rare Disease Framework

Pink Sheet editors discuss the reasons Office of Generic Drugs Director Iilun Murphy decided to step down for another position and the potential impact of the FDA’s ideas for systematic rare disease...

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Wondering if this issue will lead to guidance changes ... @PharmaPinkSheet: Industry Worries About Misbranding Exposure In US FDA’s Distributed Manufacturing Path insights.citeline.com/pink-s…

Industry Worries About Misbranding Exposure In US FDA’s Distributed Manufacturing Path

Industry groups largely support the FDA’s proposal to let distributed manufacturing networks register as one establishment, but they also want wider eligibility criteria.

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What is the definition of policy @RPMReportMike? @PharmaPinkSheet: International Trials Blog Raises Questions About US FDA Communications, Definition Of ‘Policy’ insights.citeline.com/pink-s…

International Trials Blog Raises Questions About US FDA Communications, Definition Of ‘Policy’

An article outlining the US FDA’s thinking on data from foreign trials is framed as a warning to biopharma sponsors and sounds like a call to action, but also claims not be a “new policy.”

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An interesting deep dive on spinal cord injury treatments in @PharmaPinkSheet that is a follow-up to an interview with Janet Woodcock on the subject: Spinal Cord Injury Trials Turn To Function Over Strength With NervGen’s RESTORE As Test Case insights.citeline.com/pink-s…

Spinal Cord Injury Trials Turn To Function Over Strength With NervGen’s RESTORE As Test Case

NervGen's RESTORE trial, which dosed its first patient Oct. 12, is a rare pivotal spinal cord injury study built on the patient-informed functional primary endpoint GRASSP as sponsors look beyond...

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Wondering how this will play out ... @PharmaPinkSheet: Peptides Interim Access Policy Advancing Despite US FDA Staff Concerns insights.citeline.com/pink-s…

Peptides Interim Access Policy Advancing Despite US FDA Staff Concerns

The debate over allowing peptide compounding between career FDA staff and HHS leadership could present an early challenge for FDA Commissioner nominee Heidi Overton if she is confirmed.

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There may be consequences to shrinking the @FDA user fee commitment letter size ... @PharmaPinkSheet @RPMReportMike: User Fee Deflation: PDUFA Goals Letter Shrinking Along With Fees insights.citeline.com/pink-s…

User Fee Deflation: PDUFA Goals Letter Shrinking Along With Fees

The next iteration of the Prescription Drug User Fee Act will be a landmark moment for the 35-year-old program because for the first time, the US FDA and industry agreed to do less.

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The @PharmaPinkSheet's @PinkSheetSutter went in-depth on the history of consumer rep votes and found they often voted with the majorty ... Consumer Reps Rarely Swung US FDA Advisory Committee Votes, But Often Sided With Majority insights.citeline.com/pink-s…

Consumer Reps Rarely Swung US FDA Advisory Committee Votes, But Often Sided With Majority

The FDA made consumer representatives nonvoting positions on many advisory committees, but a Pink Sheet analysis suggests the change is unlikely to alter outcomes. They voted with the majority 83% of...

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ICYMI yesterday, the big personnel move at the @FDA's generic drugs office ... @PharmaPinkSheet: US FDA Generic Drugs Office Director Steps Down Amid ‘Political Pressure,’ Admin Burden insights.citeline.com/pink-s…

US FDA Generic Drugs Office Director Steps Down Amid ‘Political Pressure,’ Admin Burden

Iilun Murphy decided to step down as Office of Generic Drugs director for an associate director position, another senior leadership change under the Trump Administration.

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I wonder when Congress will deal with this issue? @PharmaPinkSheet ... Medicare Part D Plans Stabilizing But 2030 Premium Cliff Needs Attention, CMS’ Brooks Says insights.citeline.com/pink-s…

Medicare Part D Plans Stabilizing But 2030 Premium Cliff Needs Attention, CMS’ Brooks Says

CMS is eager to work with Congress to control premium growth in Part D once the existing 6% cap on the base beneficiary premium expires, Center for Medicare Director John Brooks said.

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The @PharmaPinkSheet's @PinkSheetSutter with a great take on yesterday's big rare disease news from the @FDA: US FDA’s Rare Disease Framework Envisions Systematic Regulatory Flexibility insights.citeline.com/pink-s…

US FDA’s Rare Disease Framework Envisions Systematic Regulatory Flexibility

The FDA’s cross-agency initiative to build a fit-for-purpose framework would expand reviewer engagement with external experts, embed patient input at defined milestones, and apply risk-based approa...

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A @PharmaPinkSheet scoop from @PinkSheetSutter, @MaaishaO and myself. A new Office of Generic Drugs director is coming to the @FDA ... insights.citeline.com/pink-s…

US FDA Generic Drugs Office Director Steps Down Amid ‘Political Pressure,’ Admin Burden

Iilun Murphy decided to step down as Office of Generic Drugs director for an associate director position, another senior leadership change under the Trump Administration.

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For those who follow @FDA advisory committee, this is an interesting twist in the reform effort. One of my stories for @PharmaPinkSheet: US FDA Cell And Gene Therapy Adcomm Is Latest To Shrink Core Voting Membership insights.citeline.com/pink-s…

US FDA Cell And Gene Therapy Adcomm Is Latest To Shrink Core Voting Membership

The FDA gene therapy advisory committee charter renewal reduced the number of core voting members, which could be the agency’s latest effort to reshape the process.

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Curious if one of the benefits of price negotiation actually is reimbursement reform ... @PharmaPinkSheet: Could Medicare Price Negotiation Tip The Scales Toward Part B Drug Payment Reform? insights.citeline.com/pink-s…

Could Medicare Price Negotiation Tip The Scales Toward Part B Drug Payment Reform?

CMS Medicare Director David Brooks acknowledged concerns about the impact that Medicare negotiated prices for Part B drugs would have on providers, but said Congress must fix them.

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For your pediatric drugs radar ... @PharmaPinkSheet: US FDA Eager To Accelerate Pediatric Lupus Research, Change ‘Tedious’ Label Update Process insights.citeline.com/pink-s…

US FDA Eager To Accelerate Pediatric Lupus Research, Change ‘Tedious’ Label Update Process

The FDA is encouraging lupus drug sponsors to consider enrolling pediatric patients in or alongside their pivotal trials to more quickly add pediatric indications to treatments.

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