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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Michael Davis, MD, PhD
566 posts
Michael Davis, MD, PhD
@FDACDERDirector
Official X account of the Acting Director of FDA’s Center for Drug Evaluation and Research (CDER): Dr. Michael Davis since May 2026
Silver Spring, MD Katılım Ekim 2020
51 Takip Edilen3.6K Takipçiler
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@US_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. accessdata.fda.gov/scripts/cder/p…
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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_…
YouTube
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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
FDA Biologics@FDACBER
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_ls7…
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Michael Davis, MD, PhD retweetledi
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!
U.S. FDA@US_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 fda.gov/news-events/pr…
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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"
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. ja.ma/41JZlYR
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Michael Davis, MD, PhD retweetledi
.@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."
Rapid Response 47@RapidResponse47
.@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-ale…
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@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.
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@FDACDERDirector @US_FDA My son is 19yo - I’ve been fighting this fight, in mtgs/on panels at FDA, author on pubs, developing PROMs now used in trials, founding/running Project Alive in its 1st 5 years. That my son+others may not be able to access drug simply bc that effort took 17 years is unbelievable.
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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/pr…
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@unknown_tester_ @US_FDA Hi, I was not reading off a script in this video.
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@FDACDERDirector @US_FDA she is reading off a script and still it came out like that????? lol
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@Macro_First @US_FDA Thanks @Macro_First . I'm glad that you brought this up. I hope it shines through my spoken and written words on this account that I am speaking from the heart and truthfully - to the best of my knowledge.
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@FDACDERDirector @US_FDA @FDACDERDirector You seem like a really good person, with a life dedicated to meaningful work. This seems like a great step forward and progress for patients in need. We sincerely hope that you are not feeling pressurized to say certain things publicly to spin a narrative.
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@US_FDA 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-inf…
Dr. Marty Makary@DrMakaryFDA
Today: another action to stop unnecessary animal testing. We can do better.
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Michael Davis, MD, PhD retweetledi
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.
Children's Hospital@ChildrensPhila
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 retweetledi
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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Michael Davis, MD, PhD retweetledi
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/pr…
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