FDA CDER Director

Official X account of the Acting Director of FDA’s Center for Drug Evaluation and Research (CDER)

[FDA CDER Director @FDACDERDirector]

🚨 We're moving!
To stay up to date on the latest news, announcements, and updates from CDER, follow us at @FDADrugs.
This account will no longer be actively updated and will be deactivated on 9/12, so make the switch today—we'll see you there!

[FDA CDER Director @FDACDERDirector]

Cardiovascular disease is the leading cause of death in the U.S., and high cholesterol is one of its most important, and modifiable, risk factors. Today's approval reflects our commitment to expanding patient access and tackling chronic disease.

[U.S. FDA @FDA]

FDA has approved the first oral PCSK9 inhibitor to reduce LDL ("bad") cholesterol in adults with high cholesterol. Until now, PCSK9 inhibitors were only available as injections. The once-daily tablet provides an additional treatment option for adults who need further LDL-C reduction despite existing therapies.

[FDA CDER Director @FDACDERDirector]

As interest in psychedelic therapies grows, strong science must lead the way. This new guidance helps ensure patients can access therapies that uphold the FDA’s gold standard for safety and effectiveness.

[U.S. FDA @FDA]

FDA is taking new steps to support the development of potential psychedelic drug therapies for serious mental health conditions. Today, FDA, issued final guidance for industry on clinical investigations of psychedelic drugs, announced a public hearing to gather stakeholder input and expanded scientific collaboration with @DeptVetAffairs.

[FDA CDER Director @FDACDERDirector]

Great news for patients before we head into flu season! Expanding access to single-dose flu treatments is a critical public health priority.

[U.S. FDA @FDA]

FDA approves the first generic single-dose pill to treat and help prevent the flu in certain patients ages 5 and older. #GenericDrugs

[FDA CDER Director @FDACDERDirector]

We will continue holding companies accountable.

[FDA CDER Director @FDACDERDirector]

Protecting consumers from false and misleading claims about compounded drugs is a priority for CDER. Patients deserve to know what they're getting — compounded GLP-1 products have not been proven safe, effective, or of consistent quality like FDA-approved drugs.

[U.S. FDA @FDA]

FDA issued 25 warning letters to telehealth companies for false and misleading claims about compounded GLP-1 products.

Unlike FDA-approved drugs, these products have not been proven to be safe, effective, or of consistent quality.

Learn more: https://t.co/hgvVy5xM3K

[FDA CDER Director @FDACDERDirector]

Saving lives starts with access. Another OTC naloxone nasal spray is now approved, no prescription needed. Empowering everyday people to act fast in an overdose emergency is proven to save lives.

[U.S. FDA @FDA]

FDA has approved Rextovy, a 4mg naloxone hydrochloride nasal spray, as an over-the-counter drug for the emergency treatment of opioid overdose.

This action aligns with the Great American Recovery Initiative, a federal effort to tackle addiction & substance use disorder through prevention, treatment, and long-term recovery.

[FDA CDER Director @FDACDERDirector]

Proud to share this milestone from our Office of Nonprescription Drugs. This is the kind of progress we can achieve when we modernize our processes and apply sound science to regulatory decisions.

[U.S. FDA @FDA]

The first new sunscreen active ingredient in 20 years! As the temperatures heat up this summer, FDA is happy to announce expanded options for consumers. Learn more: https://t.co/01tLN5fyiU

[FDA CDER Director @FDACDERDirector]

By providing clear, science-based guidance for generic drug development, we're helping to lower costs and drive competition that ultimately benefits American patients.

[FDA CDER Director @FDACDERDirector]

Affordable medicines aren't a luxury — they're a necessity. Today's release brings us closer to a marketplace where patients can access the safe, effective, high-quality treatments they need without financial hardship.

[U.S. FDA @FDA]

Today, FDA published 71 new and revised product-specific guidances (PSGs) to improve access to safe, effective, and affordable medications. PSGs facilitate the timely development of high-quality generic drugs by bringing greater efficiency and transparency to the process. https://t.co/DXB1MlaXc2

[FDA CDER Director @FDACDERDirector]

Note: Posts prior to May 15, 2026, were authored by former CDER Directors.

[FDA CDER Director @FDACDERDirector]

Fascinating discussion at @US_FDA Monday👇about the Plausible Mechanism guidance & the groundbreaking work in individualized medicine of Drs Vallabh, Ahrens-Nicklas & Musunuru (all pictured left); Dr Vijay Kumar & I are moderating on the right.

Link: https://t.co/BOqBO2TYtY

[FDA CDER Director @FDACDERDirector]

Today, Vijay Kumar & I will moderate this livestreamed discussion of @US_FDA Plausible Mechanism framework with guests:

Rebecca Ahrens-Nicklas, MD, PhD (UPenn)
Lindsey George, MD (UPenn)
Kiran Musunuru, MD, PhD (UPenn)
Sonia Vallabh, PhD (Broad Institute)

+ internal FDA experts

[FDA Biologics @FDACBER]

Join FDA via livestream for a discussion on the plausible mechanism guidance and its applicability to both CDER and CBER products: https://t.co/MP4aQZvVI8

[Dr. Marty Makary @DrMakaryFDA]

TWO DAYS after receiving the application, FDA greenlit the new pancreatic cancer drug daraxonrasib for expanded access.

This drug has also been granted a national priority voucher, which means a full application could be reviewed in a matter of weeks instead of 10-12 months.

[FDA CDER Director @FDACDERDirector]

👇A truly unbelievable treatment for 1 form of congenital deafness:

A gene therapy that results in a functional OTOF gene in the hair cells of the cochlea, causing them to produce the protein otoferlin which results in restoration of signals to the auditory nerve➡️brain=hearing!

[U.S. FDA @FDA]

Today FDA approved the first-ever gene therapy for the treatment of genetic hearing loss under the National Priority Voucher Program.
✅6th approval under the National Priority Voucher Program
✅Approved 61 days after filing

https://t.co/Modecu7S50

[FDA CDER Director @FDACDERDirector]

Out today in @JAMA_current :

An update from the @US_FDA on our progress & specific accomplishments in the year following the publication of our "Roadmap to Reducing Animal Testing in Preclinical Safety Studies"

[JAMA @JAMA_current]

💬 Perspective: The FDA’s Roadmap to Reducing Animal Testing advances #NewApproachMethodologies as alternatives to routine animal studies, reflecting scientific, ethical, and regulatory shifts in preclinical drug safety evaluation.

https://t.co/8cHkzOAvhs

[Rapid Response 47 @RapidResponse47]

.@DrMakaryFDA: "Today, the @US_FDA is also announcing the first ibogaine investigational new drug clearance. This will pave the way for the first ever human trials in the United States."

[FDA CDER Director @FDACDERDirector]

The FDA just approved Filspari for a subtype of FSGS without nephrotic syndrome. FSGS causes progressive kidney damage and affects children & adults.

Here👇we discuss the drug & the CDER review team’s interpretation of the data that led to the approval.

https://t.co/KD9GBrSF9K

[FDA CDER Director @FDACDERDirector]

@melissajhogan @US_FDA Melissa, thank you for this great question and for advocating for your son. I am working on a follow up Q&A video where I intend to address this.

Stay tuned and please encourage others to ask questions.

[FDA CDER Director @FDACDERDirector]

The @US_FDA CDER just approved a new treatment for Hunter Syndrome.

I discuss what Hunter Syndrome is, the data the approval was based on, the post marketing requirement and what this means for families who have children with the disease.

For more info👇
https://t.co/R7JYxyKWqv

[FDA CDER Director @FDACDERDirector]

@unknown_tester_ @US_FDA Hi, I was not reading off a script in this video.