Sarah Karlin-Smith

One of FDA's Oncology Division has lost what is essentially the equivalent of a full drug review team. It's malignant hematology review teams are expected to have a staff less than half the intended size as more staff depart this August. insights.citeline.com/pink-sheet/age…

Worth revisiting the new CDER Director's role in this meeting. via @RPMReportMike insights.citeline.com/pink-sheet/com…

The latest @PharmaPinkSheet podcast is posted! Join @SarahKarlin, @PinkSheetSutter, and @PinkSheetHobbs and I as we talk vaccine politics and the @US_FDA RIF: insights.citeline.com//pink-sheet/po…

Physician administered drug manufacturers and prescribers are mobilizing to oppose requirements that Medicare negotiated drug prices be included in average sales price calculations, which could erode prices in Medicare Advantage & commercial insurance. insights.citeline.com/pink-sheet/mar…

mifepristone litigation continues to pose risks for FDA and drug regulation overall... insights.citeline.com/pink-sheet/leg…

I co-wrote this for @PharmaPinkSheet with @SarahKarlin and @PinkSheetSutter. CDER sent 600 RIF notices on Monday evening, but staff losses piled up in the months before that: US FDA’s Drugs Center Lost Hundreds Of Staff Through June With 600 RIFs Coming insights.citeline.com//pink-sheet/ag…

only 18 people added last two quarters. this is just drug center but hard to square with Makary’s comments they’re hiring tons reviewers.

For FY 2025 through 3rd quarter, which ended 6/30, CDER reported 120 hired & 473 departures, a net loss of 353 ppl. But figure is missing key inputs, including RIF finalized on 7/14. Multiple FDA sources said about 600 RIF notices were sent to staff 7/14 insights.citeline.com/pink-sheet/age…

Access Risks Loom For All Drugmakers With Fourth Circuit Mifepristone Decision insights.citeline.com/pink-sheet/leg…

Long-held criticisms of the secretive nature of the development of the US Food and Drug Administration’s Prescription Drug User Fee Act “commitment letter” with industry may have finally met their moment for reform. insights.citeline.com/pink-sheet/age…

With 22 novel medicines approved in the first 6 months of 2025, the FDA is already behind its average approval count for the first half of the year, and the user fee calendar for the second half does not look ready to change the story. insights.citeline.com/pink-sheet/pro…

Due to concerns Trump staffing changes will impact medical product reviews, FDA would be required to provide Congress w/ new quarterly reports on spending or risk not receiving all funding intended 4 Commissioner's office under Senate Approps FY26 bill insights.citeline.com/pink-sheet/pat…

This is so common and so dangerous. People pull their vehicles up over crosswalks like it's nothing. Anyone using the crosswalk is forced either to walk where cars are driving or to walk in between vehicles. Both are dangerous.

As we were covering this story, my team & I were attacked by Israeli settlers. The back window of our vehicle was smashed, but we managed to escape unharmed. This is just a sliver of the reality many Palestinians face in the West Bank amid rising settler violence.

but if you eat the ice cream are you allowed to get medicaid?

Earlier this year, DC Water changed a policy for multi-family buildings: If a bill isn’t paid, the water will be shut off – for everyone who lives there. That means tenants who have no control over the building's water bill are suffering the consequences. 51st.news/dc-building-re…

and by easier to find you can download a zip drive of PDFs with file names that don't provide you any clue what you are opening...