Official X account of the Acting Director of FDA’s Center for Drug Evaluation and Research (CDER): Dr. Michael Davis since May 2026
Joined October 2020
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28 Photos and videos
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.
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: fda.gov/news-events/press-an…
ALT A person wearing a sunhat and sunglasses holds a child with a yellow hat, who has sunscreen on their face. Both are smiling outdoors on a sunny day. The image includes a text overlay: "FDA expands sunscreen options for the first time in 20 years." The FDA logo is in the top right corner.
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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.
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. accessdata.fda.gov/scripts/c…
ALT The image is an infographic issued by the FDA. It states "71 product-specific guidances for generic drug development." Highlights include "23 new guidances," "54 for products with no approved generics," and "32 for complex products." Icons of medicine jars, a medical cross, and a syringe are displayed at the top.
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By providing clear, science-based guidance for generic drug development, we're helping to lower costs and drive competition that ultimately benefits American patients.
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Note: Posts prior to May 15, 2026, were authored by former CDER Directors.
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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: youtube.com/watch?v=1OdI5_ls…
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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
May 1
Join FDA via livestream for a discussion on the plausible mechanism guidance and its applicability to both CDER and CBER products: youtube.com/live/1OdI5_ls7vA…
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Michael Davis, MD, PhD retweeted
May 1
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.
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👇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!
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
fda.gov/news-events/press-an…
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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"
Apr 20
💬 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.
ja.ma/41JZlYR
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Michael Davis, MD, PhD retweeted
.@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."
.@POTUS announces "historic reforms to dramatically accelerate access to new medical research and treatments based on psychedelic drugs."
"Since 9/11, we've lost over 21x more veteran lives to suicide than on the battlefield... and today, we're bringing them new hope."
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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.
fda.gov/drugs/drug-alerts-an…
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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👇
fda.gov/news-events/press-an…
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One important point I should have made in the video is that the surrogate marker, heparan sulfate, was reduced in the cerebrospinal fluid.
A second important point is the treatment is given via a weekly IV infusion.
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Yes -- this "new guidance" is our FDA CDER NAMs draft guidance here 👇, released one week ago.
Public comment is open for the next 54 days
fda.gov/regulatory-informati…
Mar 18
Today: another action to stop unnecessary animal testing. We can do better.
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HHS was honored to welcome Drs. Becca Ahrens-Nicklas and Kiran Musunuru to share their historic work with baby KJ.
HHS and @US_FDA are committed to advancing safe and effective therapies for rare diseases and ensuring no family is overlooked because their condition is uncommon.
Drs. Becca Ahrens-Nicklas & Kiran Musunuru joined the @FDA to announce a new “plausible mechanism” framework to speed approvals for rare diseases where large, randomized trials aren’t possible. This was inspired by their work w/ our patient KJ. More: ms.spr.ly/6013QkCPR.
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Michael Davis, MD, PhD retweeted
Mar 5
FDA is moving with unprecedented agility.
Today we approved a multiple myeloma drug just 55 days after the application was filed. And last week’s approval (a major leap forward) was approved in 44 days.
If a trial result shows immediate promise for many Americans, why wait?
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Reflecting the FDA's commitment to accelerating cures and expanding treatment options for patients with serious and unmet needs, the agency approved expanded use of Wellcovorin (leucovorin calcium) tablets to treat cerebral folate deficiency in adult and pediatric patients who have a confirmed variant in the folate receptor 1 gene (CFD-FOLR1).
Leucovorin is the first treatment for this rare genetic condition. Learn more: fda.gov/news-events/press-an…
ALT The image features text stating, "FDA approves first treatment for patients with cerebral folate transport deficiency," on a blue background. The FDA logo is in the bottom left corner, and there are decorative red and white stars at the bottom.
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Michael Davis, MD, PhD retweeted
Today FDA approved the first generic of Flovent HFA (fluticasone propionate) inhalation aerosol, 44 mcg, for maintenance treatment of asthma as prophylactic therapy in patients 4 years and older.
fda.gov/drugs/drug-safety-an…
#Asthma #GenericDrugs
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Michael Davis, MD, PhD retweeted
Mar 3
We appreciate the @WSJ making this important correction but they should have never published unverified hearsay in the first place. Smearing officials with false allegations and then issuing a quiet correction isn’t accountability. Your readers deserve better.
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Dr. Vinay Prasad and @TracyBethHoeg held a panel this morning on Personalized Medicine at #JPMHC26, where they discussed the agency's path toward marketing authorization for ultra-rare disease individualized therapies as well as the success of the Commissioner's National Priority Vouchers pilot program and the extraordinary cross-center collaboration they've developed under the leadership of @DrMakaryFDA.
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