Ramsey Baghdadi

Washington, D.C.

Co-founder at Prevision Policy

Contributing Editor at The Pink Sheet

Co-Founder, Prevision Policy

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Articles

DOGE-ing US FDA: Three Scenarios For What Comes Next

1 month ago | insights.citeline.com | Michael McCaughan |Ramsey Baghdadi

DOGE-ing US FDA: Three Scenarios For What Comes NextThe US FDA has navigated one round of layoff notices, but more cuts could be coming. Here are three potential scenarios. One scenario for FDA restructuring could be combining the drug and biologics centers. (Shutterstock)
US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics

2 months ago | insights.citeline.com | Ramsey Baghdadi

US FDA In ‘First Stages’ Of Reconsidering Black Box For Antipsychotics Patient advocates and sponsors want the US to reconsider a 20-year-old class warning against the use of antipsychotics in patients with dementia. The agency is weighing the issue, but also defending the current labels of newer agents. Sponsors want the boxed warning for antipsychotic drugs applied on a case-by-case basis rather than class-wide. (Shutterstock)
Acting Commish Brenner May Bring IT Focus

2 months ago | insights.citeline.com | Ramsey Baghdadi

Acting Commish Brenner May Bring IT FocusSara Brenner has been a key figure in the FDA’s diagnostics team, but her choice as acting FDA commissioner likely has more to do with her background with advanced technology and comfort level with the tech-focused side of the Trump transition team.
US FDA Acting Commissioner Pick Could Underscore Trump Team’s IT Focus

2 months ago | insights.citeline.com | Ramsey Baghdadi

US FDA Acting Commissioner Pick Could Underscore Trump Team’s IT FocusSara Brenner has been a key figure in the FDA’s diagnostics team, but her choice as acting FDA commissioner likely has more to do with her background with advanced technology and comfort level with the tech-focused side of the Trump transition team. Sara Brenner's technology background may have helped her become acting FDA commissioner. (Shutterstock)
Tissue Biopsies: US FDA Urges Careful Balance Of Risk v Need In Clinical Trials

Jan 14, 2025 | insights.citeline.com | Ramsey Baghdadi

Tissue Biopsies: US FDA Urges Careful Balance Of Risk v Need In Clinical Trials In new draft guidance, the US FDA recommends sponsors carefully weigh the circumstances for requiring tissue biopsies for clinical trial subjects and emphasizes the need to limit them in pediatric studies. New draft guidance sets different standards for requiring biopsies in adult and pediatric studies. (Shutterstock)
Robert F. Kennedy Jr. As HHS Secretary: Prepare For The Worst, But Hope For The Best

Nov 18, 2024 | insights.citeline.com | Ramsey Baghdadi

Robert F. Kennedy Jr. As HHS Secretary: Prepare For The Worst, But Hope For The BestKennedy’s nomination for HHS secretary already is drawing concerns, which could mean a more conventional pick emerges, but industry should prepare for Kennedy to control the US Health and Human Services Department for at least some time. Industry should prepare for Robert F. Kennedy Jr. to serve as HHS Secretary, as well as for a more conventional pick to be installed. (Shutterstock)
VP Harris ‘Marches In’ To Presidential Campaign: Will Policy Change?

Oct 21, 2024 | insights.citeline.com | Ramsey Baghdadi

VP Harris ‘Marches In’ To Presidential Campaign: Will Policy Change? 01 Aug 2024 • By Ramsey BaghdadiThe shake up in the US presidential campaign line up could have implications for future drug pricing policies. VP Kamala Harris has been an advocate for “march in” rights and could push that policy harder than incumbent President Joe Biden. Would a President Kamala Harris change the federal government's approach to march-in rights? • Source: Shutterstock
FDA Disruption: If Trump Wins, Could Big Changes Be Coming?

Oct 17, 2024 | insights.citeline.com | Ramsey Baghdadi

FDA Disruption: If Trump Wins, Could Big Changes Be Coming? 20 Aug 2024 • By Ramsey BaghdadiThe agency is clearly on the radar of former President Trump and his new coterie of tech moguls. Would Donald Trump choose a break-the-mold or middle-of-the-road FDA commissioner? • Source: Shutterstock
ICER Hemophilia Gene Therapy Reviews Show Clear ‘Net Health Benefit’ But Caution On Patient, Payer Fronts Given Upfront Costs

Oct 15, 2024 | insights.citeline.com | Ramsey Baghdadi

ICER Hemophilia Gene Therapy Reviews Show Clear ‘Net Health Benefit’ But Caution On Patient, Payer Fronts Given Upfront Costs13 Dec 2022 • By Ramsey BaghdadiRestrictive interpretations of FDA labels for BioMarin and CSL Behring products by payers could signal slow launch of gene therapies seeking to supplant existing treatments.
US FDA Closes Out Problem Applications One Federal Register Notice At A Time

Sep 23, 2024 | pink.citeline.com | Ramsey Baghdadi

Analysis Executive Summary The refuse-to-approve decision for i02/Intarcia’s Type 2 diabetes combination product is the latest example of the FDA reaching final negative decisions on challenging regulatory cases. Source: Shutterstock Existing Subscriber? Sign in to continue reading. New to Pink Sheet? Start a free trial today!