More on new cell and gene therapy guidance from Pink Sheet, Citeline Regulatory: Cell & Gene Therapies: US FDA Broadens Acceptable Use of RWD, Registries and AI insights.citeline.com//pink-sheet/ad…

An interesting take on the GLP-1 issue and the FDA green list in Pink Sheet, Citeline Regulatory: Compounders Argue US FDA’s GLP-1 Green List Validates Legit Practices insights.citeline.com//pink-sheet/co…

This data may help explain why pharma is willing to do these deals ... Pink Sheet, Citeline Regulatory Scrip, Citeline Commercial: How Much Are Drug Companies Exposed To US Government Programs? insights.citeline.com//pink-sheet/ma…

Oncology drug development with RWE continues ... Pink Sheet, Citeline Regulatory Michael McCaughan: US FDA Eager To Advance Oncology Registries insights.citeline.com//pink-sheet/r-…

A path to potentially faster approval in the UK for these products? Pink Sheet, Citeline Regulatory: Gene Editing Therapy And Other Rare Childhood Disease Drugs Win UK ‘Innovation Passport’ insights.citeline.com//pink-sheet/ag…

There also was talk about combining registries to act as an control arm in a clinical trial in this Pink Sheet, Citeline Regulatory story: Pediatric Glioma Registries Could Test ‘Product-Agnostic’ External Controls insights.citeline.com//pink-sheet/r-…

I wonder if biosimilar development will shift based on these decisions? Pink Sheet, Citeline Regulatory: Enbrel Biosimilar Market Worries Surface After Colorado Sets Price Limit insights.citeline.com//pink-sheet/ma…

This is potentially a big deal. DOJ looking at scientific exchange about off-label use differently than FDA policy. Pink Sheet, Citeline Regulatory's Sarah Karlin-Smith has the story #fdliadpromo: Off-Label Promotion: DOJ May Take New Look At Scientific Information Exchange insights.citeline.com//pink-sheet/le…

I had a discussion with a few people about this issue at RAPS last week. Remember, the FDA reviewers still know the policy even if there's a campaign against it ... Pink Sheet, Citeline Regulatory: US FDA Guidances Tread Lightly On Trial Population Language insights.citeline.com/pink-sheet/r-a…

Another consequence of the shutdown from Pink Sheet, Citeline Regulatory: 340B Rebate Model Stalls As Medicare Negotiated Price Implementation Approaches insights.citeline.com/pink-sheet/mar…

We're starting to get a better picture explaining why these deals are happening. From Pink Sheet, Citeline Regulatory: Manufacturer Most Favored Nation Deals: How They Could Be Protected From 340B insights.citeline.com/pink-sheet/mar…

The NCPV recipients are posted by U.S. FDA: fda.gov/news-events/pr…

One of my stories for Pink Sheet, Citeline Regulatory from the RAPS mtg. What sponsors could to account for fewer adcomms: With US FDA Adcomm Meetings Disappearing, Sponsors Seek Other Outlets For Patient Voice insights.citeline.com/pink-sheet/pro…

The Pink Sheet, Citeline Regulatory's first take on the latest MFN deal and U.S. FDA CNPV awardees: EMD Serono IVF Candidate Among First US FDA Priority Voucher Recipients As Part Of MFN Deal insights.citeline.com/pink-sheet/mar…

Could this be a time for the U.S. FDA to improve and enhance regulatory flexibility? One option for dealing with the shutdown and layoffs: US FDA Could Use Shutdown To Improve Amid Growing Foreign Competition insights.citeline.com/pink-sheet/age…

The latest Pink Sheet, Citeline Regulatory podcast is posted! Sarah Karlin-Smith, Nielsen Hobbs and I discuss FDA involvement in AstraZeneca MFN deal and a new DOJ interpretation of regs on scientific exchange of info about off-label uses. NO PAYWALL! Citeline insights.citeline.com/pink-sheet/pod…

The Pink Sheet, Citeline Regulatory's Sarah Karlin-Smith has more analysis of the initial Commissioner's National Priority Voucher class: First Cohort Shows Many Routes To US FDA’s Commissioner’s National Priority Voucher insights.citeline.com/pink-sheet/age…

For those of you wondering if U.S. FDA wrote the individual DTC crackdown letters, Pink Sheet, Citeline Regulatory's Sue Sutter has the answer from a former agency official: US FDA Ad/Promo Crackdown Letters Came From OPDP Staff, Not Artificial Intelligence insights.citeline.com/pink-sheet/com…

A story from me for Pink Sheet, Citeline Regulatory on official U.S. FDA figures on departures, giving another picture of staffing stress: US FDA Drug, Biologics Centers Lost Nearly 1,000 Employees In FY 2025 Fourth Quarter insights.citeline.com/pink-sheet/age…

ICYMI this on Friday. NO PAYWALL! Pink Sheet, Citeline Regulatory ... Pink Sheet Podcast: US FDA Involved In Drug Pricing Deal, DOJ’s Off-Label Promotion Policy insights.citeline.com/pink-sheet/pod…