femboy sigma

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Senior Editor Sue Sutter discuss the impact of US Food and Drug Administration’s COVID-19 vaccine indication changes and recission of the associated emergency use authorizations, as well as the postmarketing studies that now are required (:40), and their potential impact on access and reimbursement (12:20). 

More On These Topics From The Pink Sheet

COVID-19 Vaccines: Pfizer Arguments To Keep EUA Failed To Persuade US FDA’s Prasad: https://insights.citeline.com/pink-sheet/vaccines/covid-19-vaccines-pfizer-arguments-to-keep-eua-failed-to-persuade-us-fdas-prasad-V3X2OEBZE5HRHKO7KMMCFXBM2Q/ 

US FDA Updates COVID-19 Vaccine Formulations, Revokes EUAs, ACIP Use Decision Next: https://insights.citeline.com/pink-sheet/vaccines/us-fda-updates-covid-19-vaccine-formulations-revokes-euas-acip-use-decision-next-VBXJDSOA6BCOXNCA2TAH27EBJY/ 

A US FDA Move to Revoke Pfizer’s Pediatric COVID-19 Vaccine EUA Could Raise Supply Questions: https://insights.citeline.com/pink-sheet/vaccines/a-us-fda-move-to-revoke-pfizers-pediatric-covid-19-vaccine-eua-could-raise-supply-questions-ZX26DBENHFCOHPBGMPFPQB6REQ/
 
Changes In Pediatric COVID-19 Vaccine Recommendations Causing Coverage Confusion: https://insights.citeline.com/pink-sheet/vaccines/changes-in-pediatric-covid-19-vaccine-recommendations-causing-coverage-confusion-WDEYUVJXGBCGBEVBQ2I6INH554/ 

Drug Fix: US FDA Changes COVID-19 Vaccine Labeling, Reimbursement Confusion Rises

The FDA approved a blood test for early detection of Alzheimer's disease that should, for the first time, open the door to testing accessibility for more of those at risk.

FDA Approves Blood Test to Diagnose Alzheimer's

Pink Sheet Executive Editor Derrick Gingery, Managing Editor Bridget Silverman, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs consider the ongoing impact of the US Food and Drug Administration decision to drop vaccine expert Paul Offit and others from its advisory committee rosters (:32), as well as the substantial new detail in the latest batch of complete response letters for unapproved products that the agency released (12:47).

More On These Topics From The Pink Sheet
Offit’s VRBPAC Departure Raises Questions About Another HHS Panel Revamp: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-paul-offit-no-longer-member-of-us-fdas-vaccine-advisory-panel-WX3X3CIP6VCARJ7BPLXNQIQ2BQ/ 

US FDA Compounding Advisory Panel Hit Hardest By Recent Purges: https://insights.citeline.com/pink-sheet/product-reviews/us-advisory-committees/us-fda-compounding-advisory-panel-hit-hardest-by-recent-purges-OXBD4IXGFZCIDIMB6VXSOSVP6U/ 

89 Complete Response Letters For Unapproved Drugs, One Huge Leap For US FDA Transparency: https://insights.citeline.com/pink-sheet/product-reviews/complete-response-letters/89-complete-response-letters-one-huge-leap-for-us-fda-transparency-for-unapproved-drugs-SLYA5LADMNDY3LKZ5TRUAWRRAU/

Drug Fix: US FDA Drops Offit, Others From Adcomms, Releases Unapproved Product Rejection Letters

Episode 395: Erez Kaminski - CEO & Founder, Ketryx

What makes a biotech-CRO partnership truly work? Claire Riches, VP, Clinical Solutions, Citeline, and Matt Simmons, Senior Director, Oncology Strategy, IQVIA Biotech, share the secrets behind winning biotech-CRO partnerships, covering collaboration, transparent budgeting, regulatory navigation, and recruitment strategies, with essential insights to help biotechs succeed from their first RFP to global trials.

View the video series and find out more information here: https://www.citeline.com/biotech

Drive Early CRO Engagement to Optimize Funding, Trial Design, and Recruitment in Biotech

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, Senior Editor Sue Sutter, and Editor-in-Chief Nielsen Hobbs look at the potential consequences of the US Food and Drug Administration’s upcoming crack down on direct-to-consumer advertising (:30), including the first publicly released letter, which went to AstraZeneca for a Flumist TV commercial (2:50), as well as vaccine policy and other major issues that were listed in the Make America Healthy Again Commission’s Strategy Report (21:45).

More On These Topics From The Pink Sheet

Direct-To-Consumer Ads: Manufacturers Face ‘Cease And Desist’ Orders Now, Uncertain Future: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/direct-to-consumer-ads-manufacturers-face-cease-and-desist-orders-now-uncertain-future-6XLXAWS7WJBYNPHSBRAQVTBARU/ 

Limited Detail In MAHA Strategy Report Could Catch Pharma Off Guard: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/limited-detail-in-maha-strategy-report-could-catch-pharma-off-guard-TVL7CCBQONA7PHCLUDJ7WTEJC4/ 

Drug Fix: US FDA DTC Ad Crackdown Emerges From MAHA Report

Durante el evento en conmemoración de Charlie Kirk, el activista de la derecha cristiana asesinado durante una de sus presentaciones hace unos días, Donald Trump dejó claro —como si necesitara— quién es.

Carlos Puig. Los días del trumpismo… y lo que falta

The FDA's new Computer Software Assurance (CSA) guidance marks a pivotal shift for the medical device industry, moving away from the rigid, documentation-heavy Computer System Validation (CSV) that has historically slowed innovation and the adoption of modern digital tools like eQMS. This new framework introduces a risk-based, critical-thinking approach designed to reverse the traditional 80/20 effort from documentation to value-added assurance activities. By classifying software functions into a simple binary of "high process risk" versus "not high process risk," CSA allows manufacturers to tailor their validation efforts, applying rigorous scripted testing only where a failure could foreseeably impact patient safety, while using more flexible and efficient unscripted methods for lower-risk functions. This change not only streamlines the validation of automated systems and clarifies the path for cloud-based platforms but also fundamentally reshapes the relationship with software suppliers, creating a "leverage economy" where vendor assurance packages become a critical component of a manufacturer's compliance strategy, ultimately fostering faster innovation, greater efficiency, and a stronger focus on product quality and patient safety.

CSV to CSA: How the FDA's New Software Assurance Guidance Ends MedTech's  Validation Gridlock and Unleashes Innovation

Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith, and senior editors Sue Sutter and Cathy Kelly consider the impact of the government shutdown on the US Food and Drug Administration, as well as industry (:21), and discuss the future of drug pricing after Pfizer completes its deal with the White House to embrace its Most Favored Nation plan (10:29). 

More On These Topics From The Pink Sheet

Shutdown Approaches: US FDA Would Retain Most Of Recently Trimmed Staff: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-approaches-us-fda-would-retain-most-of-recently-trimmed-staff-DTVAHLBI5VGZBPHD76TLNDIBGU/ 

Shutdown Day One: US FDA Hiring, MFN Demos Delayed?: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/shutdown-day-one-us-fda-hiring-mfn-demos-delayed-7LGCITF2WVCJNEVUTWZV5MOZSE/ 

Closing The Gap? Pfizer Will Set Same US, Foreign Launch Prices In MFN Deal: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/closing-the-gap-pfizer-will-set-same-us-foreign-launch-prices-in-mfn-deal-ZRSNU56KTFGRBBX4Y5OJKLFV6Y/ 

Questions Persist About How Pfizer’s US Agreement Lowers Prices: https://insights.citeline.com/pink-sheet/market-access/pricing-debate/questions-persist-about-how-pfizers-us-agreement-lowers-prices-T2TEWMKVMVHGJHPXDKIFDF2GWA/

Drug Fix: Government Shutdown’s Impact On US FDA, Pfizer Inks Drug Pricing Deal

Citeline places biopharma and medical device professionals, and those who focus on these industries, at the forefront of knowledge and insight, by providing the perfect combination of news and information together with penetrating insight and analysis. Citeline is a leader in the field of healthcare industry information.

Michael B. Cohen is an elder law attorney whose Dallas law practice focuses on the legal needs of the disabled and elderly, including estate and Medicaid and other public benefits (such as Veterans benefits) planning. He is a frequent speaker on these topics.

The VentureFizz Podcast is the flagship podcast of VentureFizz.com, the leading authority for jobs & careers in tech. In this podcast, VentureFizz Founder Keith Cline interviews the top founders and investors in the tech industry.

Milenio Opinión es un espacio que recopila las firmas de los columnistas y colaboradores de Grupo Milenio.

New tracks tagged #FDA