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One Lesson Of The OND Reorg: It Is Hard To Classify Diseases

 
• By Michael McCaughan

One goal of proposed overhaul of US FDA’s Office of New Drugs is creating more logical alignment of related diseases within divisions and offices. That is easier said than done.

two hands trying to connect couple puzzle piece with sunset background. Jigsaw alone wooden puzzle against sun rays. one part of whole. symbol of association and connection. business strategy.

The US FDA’s first public unveiling of the planned overhaul of the Office of New Drugs is filling in some of the details on a critical structural change for biopharma companies.

One thing has been clear for several weeks: the new OND will have more drug review divisions and offices. (Also see "US Office Of New Drugs Revamp Taking Shape:...

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US FDA Punts On New COVID-19 Framework’s Impact On Fall Shots

 
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The FDA’s advisors split on whether to update COVID-19 vaccines for the fall. The agency refused to discuss the impact of the new vaccine framework on availability.

Pfizer’s All-Comers CRPC Dream For Talzenna Quashed For Lack Of Biomarker-Negative Rigor

 
• By Bridget Silverman

The lack of a formal analysis of efficacy in castration-resistant prostate cancer patients without HRR mutations doomed Pfizer’s Talzenna at the US FDA's Oncologic Drugs Advisory Committee, as FDA oncology chief Richard Pazdur says chance cannot be ruled out.

Darzalex Faspro Gains US FDA AdComm Support For Smoldering Myeloma Claim

 
• By Bridget Silverman

The use of J&J’s Darzalex Faspro in high-risk smoldering multiple myeloma could result in overtreatment, but the FDA committee voted in favor of the new claim for delay in development of multiple myeloma.

STARGLO Dulled: Genentech’s Columvi Data Not Generalizable To US Patients, FDA Panel Says

 
• By Sue Sutter

The glofitamab trial results are not generalizable due to the small number of enrolled US lymphoma patients and adverse results across multiple endpoints for patients from non-Asian regions, the Oncologic Drugs Advisory Committee said.

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Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
• By Derrick Gingery

The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.

US ‘Most Favored Nation’ Pricing Could be Game Changer for Drug Access In Germany

 
• By Francesca Bruce

In this first in a series of articles looking at the potential impact of the MFN drug pricing policy on European pharmaceutical markets, EUCOPE’s Alexander Natz tells the Pink Sheet why the US policy underscores the importance of confidential net pricing.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.