Derrick (@dgingery) profile picture

Derrick

@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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I wonder which nominees will be selected ... @PharmaPinkSheet: ACIP Seeks New Members, Suggesting Resurgence In 2027 insights.citeline.com/pink-s…
ACIP Seeks New Members, Suggesting Resurgence In 2027

ACIP Seeks New Members, Suggesting Resurgence In 2027

Despite its legal issues, HHS still can appoint ACIP members and wants nominations by Dec. 31.

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A big question remains whether the framework initiative can fix the issues that have lingered for years ... @PharmaPinkSheet @RPMReportMike: From Flexibility To Framework: US FDA Still Searching For Right Rare Disease Message insights.citeline.com/pink-s…
From Flexibility To Framework: US FDA Still Searching For Right Rare Disease Message

From Flexibility To Framework: US FDA Still Searching For Right Rare Disease Message

The FDA’s Rare Disease Framework initiative is the latest effort to address rare disease advocates’ concerns about a misalignment between traditional safety and efficacy expectations and the realit...

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Fix the issues early so they don't become arguments later ... @PharmaPinkSheet @MaaishaO: Rare Disease Framework Will Center On Early Evidence Agreements, Not Flexibility insights.citeline.com/pink-s…
Rare Disease Framework Will Center On Early Evidence Agreements, Not Flexibility

Rare Disease Framework Will Center On Early Evidence Agreements, Not Flexibility

The FDA will settle evidence plans early in development rather than debating regulatory flexibility case-by-case at the end of a review as part of its new Rare Disease Framework initiative.

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Even though AI can do a lot, you still need a person to oversee it ... @PharmaPinkSheet: The Essential Human In The AI Real-World Evidence Ecosystem insights.citeline.com/pink-s…
The Essential Human In The AI Real-World Evidence Ecosystem

The Essential Human In The AI Real-World Evidence Ecosystem

At DIA's RWE conference, speakers agreed that AI can speed up analysis, but human judgment and accountability for evidence integrity remain vital.

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I'd just like to point out that @PharmaPinkSheet readers knew three weeks ago that FDA staff opposed the peptides temporary order: insights.citeline.com/pink-s…
US FDA Staff Push Back Against Trump Administration Interim Peptide Dispensing Order

US FDA Staff Push Back Against Trump Administration Interim Peptide Dispensing Order

FDA staff said the move to allow compounding of some unapproved peptide products raises patient safety concerns and weakens the drug approval process.

insights.citeline.com
Matthew Perrone (@AP_FDAwriter) profile pictureMatthew Perrone@AP_FDAwriterOct 28
SCOOP: A Trump administration plan to give Americans easier access to unproven peptides was opposed by FDA drug staffers, who had limited input in drafting the policy. apnews.com/article/peptides-…
RFK Jr. eases access to unproven peptides despite opposition from FDA scientists

RFK Jr. eases access to unproven peptides despite opposition from FDA scientists

Food and Drug Administration staffers had little input on the Trump administration's decision that eases access to peptide drugs favored by Health Secretary Robert F.

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Compounding policy is out: public-inspection.federalreg…
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For your Medicaid and gene therapy radar ... @PharmaPinkSheet: Medicaid Cell And Gene Therapy Model Will Expand Beyond Sickle Cell To Rare Disease, Some Cancers insights.citeline.com/pink-s…
Medicaid Cell And Gene Therapy Model Will Expand Beyond Sickle Cell To Rare Disease, Some Cancers

Medicaid Cell And Gene Therapy Model Will Expand Beyond Sickle Cell To Rare Disease, Some Cancers

CMS is planning to open the Cell and Gene Therapy Access model to allow centralized outcomes-based contracting for gene therapies in the Medicaid program, but while the current sickle cell disease...

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This is an interesting question for @FDA and should warrant attention from industry. Great @PharmaPinkSheet story by @PinkSheetSutter: Phathom’s Voquezna Tests Limits of US FDA’s ‘Umbrella’ Exclusivity Policy insights.citeline.com/pink-s…
Phathom’s Voquezna Tests Limits of US FDA’s ‘Umbrella’ Exclusivity Policy

Phathom’s Voquezna Tests Limits of US FDA’s ‘Umbrella’ Exclusivity Policy

The FDA seeks public comment on whether Phathom’s vonoprazan can claim a combined 10 years of new chemical entity and GAIN exclusivity, a benefit earned when co-packaged with antibiotics, even though...

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The question will be what is "fit for purpose" in a specific context and will @FDA reviewers accept it? @PharmaPinkSheet @MaaishaO: US FDA Wants ‘Fit-For-Purpose’ Evidence To Become The Norm For Rare Diseases insights.citeline.com/pink-s…
US FDA Wants ‘Fit-For-Purpose’ Evidence To Become The Norm For Rare Diseases

US FDA Wants ‘Fit-For-Purpose’ Evidence To Become The Norm For Rare Diseases

Acting FDA Commissioner Kyle Diamantas, CDER Director Mike Davis and CBER Director Karim Mikhail said the Rare Disease Framework initiative is intended to make fit-for-purpose evidence the norm...

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The CMC facility lifecycle program in BsUFA IV could help reduce CRLs ... One of my @PharmaPinkSheet stories: Biosimilar Manufacturing Approvals Could Be Accelerated Via New BsUFA IV Facility Meetings insights.citeline.com/pink-s…
Biosimilar Manufacturing Approvals Could Be Accelerated Via New BsUFA IV Facility Meetings

Biosimilar Manufacturing Approvals Could Be Accelerated Via New BsUFA IV Facility Meetings

The facility lifecycle program will allow FDA-sponsor conversations about potential risks before application submission, as well as after inspections find deficiencies.

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If Chinese companies have CRLs released, would US companies piggyback off them? An interesting issue raised in the debate ... @PharmaPinkSheet @PinkSheetSutter: US FDA’s Complete Response Letter Postings A Gift To Chinese Competitors, PhRMA Says insights.citeline.com/pink-s…
US FDA’s Complete Response Letter Postings A Gift To Chinese Competitors, PhRMA Says

US FDA’s Complete Response Letter Postings A Gift To Chinese Competitors, PhRMA Says

Publishing CRLs for unapproved products exposes trade secrets and confidential commercial information and allows Chinese companies to “piggyback” off the investments of US innovators, PhRMA says in...

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An interesting take here. Wonder if other sectors will try this route as is suggested ... @PharmaPinkSheet @MaaishaO: Peptides Compounding Would ‘Undermine’ US FDA Drug Approval Process, Ex-Agency Official Argues insights.citeline.com/pink-s…
Peptides Compounding Would ‘Undermine’ US FDA Drug Approval Process, Ex-Agency Official Argues

Peptides Compounding Would ‘Undermine’ US FDA Drug Approval Process, Ex-Agency Official Argues

Center for Science in the Public Interest officials argue in JAMA that letting compounders sell unapproved peptides would erode the incentive to conduct clinical trials and strip the advisory...

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This priority from the Makary era is not going away ... @PharmaPinkSheet @MaaishaO: US FDA Plans Pilot Program for Rx-to-OTC Switches and Other Nonprescription Drugs insights.citeline.com/pink-s…
US FDA Plans Pilot Program for Rx-to-OTC Switches and Other Nonprescription Drugs

US FDA Plans Pilot Program for Rx-to-OTC Switches and Other Nonprescription Drugs

The FDA soon will launch a pilot giving nonprescription drug sponsors early, structured talks with the agency, which should help efforts to encourage more prescription to over-the-counter switches.

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An interesting idea from @FDA for its rare disease framework. @PinkSheetSutter @PharmaPinkSheet ... US FDA’s Rare Disease Framework Could Be ‘Sandbox’ For Wider Drug Development insights.citeline.com/pink-s…
US FDA’s Rare Disease Framework Could Be ‘Sandbox’ For Wider Drug Development

US FDA’s Rare Disease Framework Could Be ‘Sandbox’ For Wider Drug Development

The FDA's drugs and biologics center directors said lessons from the rare disease “mindset shift” could be leveraged for chronic condition drug development, especially where patient subsets can be...

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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 OCE Nears 10th Year

US FDA Oncology Chief Angelo De Claro Continues Patient-Centered Focus As OCE 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

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

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

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

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

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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