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 fda.gov/drugs Silver Spring, MD Joined October 2020-
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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/pr…
By providing clear, science-based guidance for generic drug development, we're helping to lower costs and drive competition that ultimately benefits American patients.
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.
Note: Posts prior to May 15, 2026, were authored by former CDER Directors.
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_…
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
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…
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.
👇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/pr…
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"
💬 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
.@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."
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…
@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.
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…
@unknown_tester_ @US_FDA Hi, I was not reading off a script in this video.
@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.
@houmanhemmati @AndrewNixonHHS @US_FDA Thank you, Dr. @houmanhemmati !
@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.
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…
Today: another action to stop unnecessary animal testing. We can do better.
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.
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?
Adam Feuerstein ✡�... @adamfeuerstein
128K Followers 799 Following Biotech reporter @statnews. Dog ❤️er. Polk Award winner. #COYS. Said one analyst: The likes of Adam Feuerstein attack viciously. On Signal: stataf.54
U.S. FDA @US_FDA
591K Followers 103 Following Our posts are FDA Approved! Privacy Policy - https://t.co/LbTJXYRXVP FDA Authentic Accounts - https://t.co/w2LNbzG7M0
Dr. Robert M. Califf @DrCaliff_FDA
11K Followers 42 Following Husband, father, grandfather. Doctor with heart(s). Commissioner of Food and Drugs - @US_FDA This account has been archived.
AZ Latina ☮️🌊�... @aVoice4ALS
4K Followers 5K Following Advocate for people w/ALS & Amyloidosis (that killed Mom). FDA must heed Congressional mandate for regulatory flexibility in all Rare Diseases. #DyingWaiting
Scott Gottlieb, MD �... @ScottGottliebMD
532K Followers 5K Following Senior Fellow @AEI. Partner @NEA. Contributor @CNBC. 23rd Commissioner of the @US_FDA. Public Boards: @Pfizer @Illumina @TempusAI @UnitedHealthGrp
Matthew Herper @matthewherper
111K Followers 3K Following Writing and events at STAT. This is biology's century; Every data point has a face. ‘21 Polk Award. Signal: MattHerper.92
ALS Advocacy @alsadvocacy
12K Followers 2K Following ALS = Lou Gehrig's Disease Thought it had been cured by now? Still no known cause. Still no cure. Still no treatment. Still quickly fatal. Still outrageous.
ALS ACCESS @brainmatters10
2K Followers 2K Following Fighting for a cure for ALS/MND/ and it’s variants. Fighting daily for many years, for ALS drug access. Sod1 Gene carrier. Animals are my Love!!
Sandra Abrevaya @sabrevaya
21K Followers 4K Following Wife to @bsw5020. Mama. Caregiver. CEO @synapticure providing medical care for Alzheimer’s, Parkinson’s and ALS. Co-founder @iamalsorg. EP @noc_film.
Tatiana Prowell, MD @tmprowell
60K Followers 9K Following Oncologist serving people w/ #cancer in #MedEd #SciComm & #bcsm. Past ASCO Ed Chair. Cofounder @HCWvsHunger. #LongCovid. Team hope/good trouble/go high. No FCOI
No More Excuses ALS W... @als_now
4K Followers 1K Following ALS advocate fighting for transparency, access to effective therapies, and ensuring ALS patients aren't victims of weak drug pharma gouging. YT: ALSNewsNow
Kandy Simons @KandySimons
1K Followers 2K Following ALS advocate. NurOwn Works and should already have FDA approval.
DRUGS @drug_smolecules
9K Followers 569 Following ☣Femtomolar potency poems and limericks ☣Oceanic Boundlessness (p=0.0001)
C. Michael Gibson MD @CMichaelGibson
430K Followers 361K Following Non-Profit Founder/Leader | ❤️ Doc | Artist Scientist Educator | News Anchor https://t.co/7OIKCgNtqr | RT ≠ endorse | Disclaimer: https://t.co/bwmE2O4rVu
Zach Brennan @ZacharyBrennan
11K Followers 1K Following Senior Editor, Endpoints News - covering the FDA, Capitol Hill, and biotech/pharma - reach me at [email protected], Signal: zacharybrennan.20
FDA Drug Information @FDA_Drug_Info
345K Followers 61 Following Receive the latest drug information from the US FDA. Contact us at 1.855.543.3784 or [email protected]. Privacy Policy - https://t.co/K2nAJlm94m.
RyuStrong_DMD @RyuStrong_DMD
19 Followers 125 Following DMD warrior and Mom advocacy team putting Jesus first while fighting for kids with DMD and access to treatments they deserve. #EndDuchnne #RareDiseaseKidsRise
Hedley Rees @PharmaFlow_
111 Followers 628 Following Globally recognised expert in biologics (including vaccines) supply chains, calling out the SARS-CoV-2 injections as defective
Mniyyati @mniyyati
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DesertDweller_ROAR_4_... @DesertDweller93
4K Followers 420 Following Crazy bio investor with ridiculously concentrated positions. If you can afford to, remember to pay it forward if you were lucky with your investments.
Sandy Walsh @SandySWalsh
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csdbiostat @csdbiostat
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Mathilde Sharman @MathildeSh7964
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Lauren Wood Heickman @doctaLaLa
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Nelson Rutrick @nelsonrutrick
165 Followers 2K Following Chief Strategy Officer @Adams Clinical, a clinical trial site that specializes in CNS. Pharma can’t test their own drugs, so Adams does it for them.
Manel Esteller @ManelEsteller
16K Followers 5K Following Investigador ICREA @icreacommunity a @IRSantPau, Catedràtic Genètica @UniBarcelona, Director Programa #Epigenètica i Biologia del Càncer
Charles Gorrivan @CGorrivan
719 Followers 1K Following Reporter @business. @standrewsir '25. @DJNF ‘23. Opinions are my own. DM for Signal.
Mike Davis @drdrmavis
58 Followers 54 Following
Sue E. Peters, PhD - ... @nomorewires
2K Followers 3K Following Developmental Cognitive Sleep Neuroscientist, Computer Scientist, Health Freedom Activist, Lover of Diversity, https://t.co/UqnPaXhDly
Peter Suzman @Biomaven
9K Followers 3K Following Long-time small-cap biotech investor & entrepreneur - currently co-founder of biotech startup. Perennial loser in New Yorker caption contest.
qaz93681 @qaz93681
27 Followers 285 Following
Brandon Richard @BreakoutBiotech
289 Followers 232 Following Long $ATAI $ABCL $TWST $PRME | Not financial advice.
Berry/Rock Analyst @agtemd1
129 Followers 1K Following Interested in Tech/Semis/Everything. Here to learn.
Lauren Brensel @LaurenBrensel
244 Followers 296 Following covering health care @politico, formerly @sunsentinel @orlandosentinel |@ufjschool alum 🐊
Ruth @Ruthswn8
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Lynn Mehler @MehlerLynn
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bowtch @bowtch
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Amanda Friedman @amandasfriedman
927 Followers 752 Following health care reporter @politico | @ufjschool and @thealligator always 🐊 | send tips to [email protected] or DM afriedman.30 on Signal.
Dr. MD @MiliDuggal
1K Followers 820 Following PhD in Maternal and Child Health. Global Health & Infectious Disease Researcher. All opinions are my own.
CokeyHaus @CokeyHaus
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Lizzy Lawrence @LizzyLaw_
5K Followers 3K Following Reporter covering the Food and Drug Administration for @statnews. Signal is lizzylaw.53, 🦋 is https://t.co/tKaJmrKTOV
Prof Jeffrey S Morris @jsm2334
15K Followers 2K Following George S. Pepper Professor of Public Health & Preventive Medicine; Biostats, Stats & AI; lifelong learner & truth seeker; Views are my own, not my employer's
tabby @TheTabet
736 Followers 593 Following
Tim @Tim_Corr
206 Followers 784 Following
Carmen Paun @carmenpaun
5K Followers 7K Following Health reporter at https://t.co/CsvmjGDtzt covering HHS and global health. @POLITICOEurope alum and fan. Tips: [email protected] or CarmenP.82
Try Tamarind @trytamarind
58 Followers 3K Following Collecting bits and pieces of life's greatest gifts....people and their experiences.... RT not= Endorsements
Jean Kim @jeankimmd
2K Followers 3K Following Psychiatrist and Writer. All comments and opinions are my own.
Hannah Abrams, MD @HannahRAbrams
6K Followers 1K Following PGY6 @FredHutch, alum @MGHMedicine @BCMHouston. SM @JCOOP_ASCO host @CuriousClinPod. Hope to improve patient/caregiver experiences in cancer care. Views my own.
Cait DeBaun @CaitDeBaun
1K Followers 697 Following Chief of Staff, @PhRMA public affairs. Taste tester for @BillDeBaun.
Stephanie Fagan @faganstephanie
157 Followers 515 Following Comms gal, daughter, wife, mom...inspired by the #thoughtsiamfollowing. Tweets = my own.
Mike Ouyang @MikeOuyang7
2 Followers 260 Following
Sean David Childers @sdchilders
254 Followers 783 Following
Kishen Mehta @KishenMehta
141 Followers 375 Following
chris @ridscm
373 Followers 4K Following Comms | Biopharma. Ex-pat from the great state of New Jersey. Tweets are most certainly my own.
U.S. FDA @US_FDA
591K Followers 103 Following Our posts are FDA Approved! Privacy Policy - https://t.co/LbTJXYRXVP FDA Authentic Accounts - https://t.co/w2LNbzG7M0
Scott Gottlieb, MD �... @ScottGottliebMD
532K Followers 5K Following Senior Fellow @AEI. Partner @NEA. Contributor @CNBC. 23rd Commissioner of the @US_FDA. Public Boards: @Pfizer @Illumina @TempusAI @UnitedHealthGrp
FDA Drug Information @FDA_Drug_Info
345K Followers 61 Following Receive the latest drug information from the US FDA. Contact us at 1.855.543.3784 or [email protected]. Privacy Policy - https://t.co/K2nAJlm94m.
Rapid Response 47 @RapidResponse47
2.0M Followers 74 Following Official White House Rapid Response account. Supporting @POTUS's America First agenda and holding the Fake News accountable. MAGA!
Dr. Marty Makary @DrMakaryFDA
59K Followers 64 Following Official account of the 27th Commissioner of the @US_FDA Catch up with FDA Direct: https://t.co/QJ6g8bH7wc
Houman David Hemmati,... @houmanhemmati
86K Followers 21K Following Board Certified MD Ophthalmologist & PhD research scientist. Biotech entrepreneur. Medicine/science author & commentator. Dad of 2. Opinions my own
Andrew Nixon @AndrewNixonHHS
488 Followers 222 Following Official account for @HHSGov Spokesman and Deputy Assistant Secretary for Media Relations. #T1D
Michael Felberbaum @FDASpox
1K Followers 47 Following Asst. Commissioner for Media Affairs at @US_FDA. Tripawd dog dad. Extremely amateur hockey player.
World Health Organiza... @WHO
12.6M Followers 2K Following We are the @UN’s health agency working for #HealthForAll Always check our latest tweets for updated advice/information.
U.S. FDA en Español @FDAenEspanol
31K Followers 1K Following Encuentra las últimas noticias de la Administración de Alimentos y Medicamentos de los E.U. --- https://t.co/65hYuf0ZRG (Polítca de Privacidad )
USForeignAssist @USForeignAssist
130K Followers 267 Following The official @StateDept account for the Under Secretary for Foreign Assistance, Humanitarian Affairs, and Religious Freedom (F). Follows/RTs ≠ endorsements.
U.S. Surgeon General @Surgeon_General
1.2M Followers 166 Following Official X account for the U.S. Surgeon General. Tweets before 01/20/25 are from prior federal officials. Privacy: https://t.co/SrVlrTW1gb
CDC Director @CDCDirector
337K Followers 471 Following @CDCgov Note: Posts prior to 1/20/25 were from former CDC directors. Privacy policy: https://t.co/qNVn53Yrr7 #publichealth #science #government
Eric D. Hargan @DepSecHargan
9K Followers 570 Following Deputy Secretary of @HHSgov. Husband and father. Regulatory reform enthusiast and proud Illinois native. Privacy: https://t.co/NG5CQCWEYd
FDA Oncology @FDAOncology
41K Followers 352 Following FDA Oncology Center of Excellence expedites medical product development to improve the lives of people with cancer.
FDA Cosmetics @FDACosmetics
14K Followers 72 Following Here you'll find the latest news and information from FDA's Office of Cosmetics. Follows and reposts do not indicate an endorsement.
Dr. Susan Mayne @DrMayneFDAFood
3K Followers 83 Following Director, FDA’s Center for Food Safety and Applied Nutrition This account has been archived.
FDA Medical Devices @FDADeviceInfo
97K Followers 401 Following Official FDA - device recalls, safety, authorizations, radiation-emitting products. Contact us [email protected] or 800-638-2041 https://t.co/hfXZUjyZz5
FDA Biologics @FDACBER
24K Followers 210 Following Latest information from the Center for Biologics Evaluation and Research. Contact us at 1-800-835-4709 or [email protected]. http://t.co/5Fo6rzyhYQ
FDA Tobacco @FDATobacco
43K Followers 279 Following Committed to ensuring a healthier life for every family. News & updates from FDA Center for Tobacco Products. Privacy Policy - https://t.co/o45IXnOmMw
FDAWomen @FDAWomen
73K Followers 688 Following The latest women's health information from the U.S. Food and Drug Administration. Privacy Policy: https://t.co/oPsmakHbDX
FDA Patient Info @FDAPatientinfo
4K Followers 100 Following The FDA Public Engagement Staff covers a range of topics and conducts numerous activities that are of interest to patients. This account is now archived.
BARDA @BARDA
10K Followers 214 Following Advancing countermeasures against 21st century health threats by bringing together public private partnerships and advancing innovation. Part of HHS/ASPR.
HHS ASPR @ASPRgov
19K Followers 186 Following ASPR leads the nation’s medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. https://t.co/tD4DjmLiXB
FDA CVM (Center for V... @FDAanimalhealth
19K Followers 57 Following Privacy Policy: https://t.co/QlZqQ87pjp. Contact us at [email protected].
CDC @CDCgov
5.5M Followers 244 Following CDC's official source for daily credible health & safety updates from Centers for Disease Control & Prevention. Privacy/comment policy: https://t.co/9LbZmE3Wzg
FDA Global @FDA_Global
5K Followers 112 Following Office of Global Policy and Strategy carries out FDA's global public health mission: overseeing foreign offices, trade policy, bilateral/multilateral relations.
FDA Commissioner @FDACommissioner
9K Followers 289 Following This is the official account of the Acting FDA Commissioner. This account is archived.
CDC Cancer @CDC_Cancer
132K Followers 100 Following This account is no longer active, and our content has moved to https://t.co/DBsfBPSJMZ. Follow us there for more.
National Cancer Insti... @theNCI
223K Followers 4K Following The U.S. government’s agency for cancer research. Part of @NIH. Engagement ≠ endorsement. Questions about cancer? Reach us here: https://t.co/yQAi9x4Obg
NIDAnews @NIDAnews
53K Followers 267 Following Official @NIH National Institute on Drug Abuse account Privacy: https://t.co/qb9Ynd92CU Commenting: https://t.co/Y5Syo20UN8 Engagement≠Endorsement
SAMHSA @samhsagov
165K Followers 538 Following Official account Substance Abuse & Mental Health Services Administration. In crisis? Call/text 988 or chat https://t.co/ElGKYJfS2c. https://t.co/uaUN4oKBGe
CMSGov @CMSGov
208K Followers 113 Following Official X account for the Centers for Medicare & Medicaid Services (CMS) | Follow @DrOzCMS
Dr. Amy Abernethy @DrAbernethyFDA
7K Followers 71 Following Former Principal Deputy Commissioner and Acting CIO at @US_FDA. This account is now archived.
Anand Shah, M.D. @AnandShahFDA
1K Followers 37 Following Former Deputy Commissioner for Medical and Scientific Affairs, U.S. Food & Drug Administration - This account is now archived.
CDC Emergency @CDCemergency
1.8M Followers 529 Following The handle for CDC's Office of Readiness and Response (ORR). We tweet ways to #PrepYourHealth, abt public health preparedness, & during emergency responses.
FEMA @fema
815K Followers 778 Following Helping people before, during and after disasters. To report an emergency, call 911 or alert local authorities. Policies: https://t.co/9t2aegFKwB
NIH @NIH
1.7M Followers 226 Following Official account of the National Institutes of Health. NIH...Turning Discovery Into Health®. Privacy Policy: https://t.co/wOGwZ3gX1M Engagement ≠ endorsement
FDA Preparedness @FDApreparedness
5K Followers 1K Following FDA's Office of Public Health Preparedness and Response, in the Office of the Chief Medical Officer
US FDA MedWatch @FDAMedWatch
55K Followers 33 Following Clinically important safety information on human medical products from FDA. Comments: [email protected] Privacy: https://t.co/xpVlP2hVsL
Media Affairs @FDAMedia
16K Followers 455 Following Official twitter account of FDA's Office of Media Affairs. Request for comment form: https://t.co/OSj4ocoElt
FDA Office of Inspect... @FDAInspects
7K Followers 76 Following Get the latest information from FDA’s Office of Inspections and Investigations. Privacy Policy - https://t.co/QnqStW5NGx
Dr. Anthony Letai @NCIDirector
32K Followers 1K Following Official account of Anthony Letai, M.D., Ph.D. Director of @theNCI from 9/29/25. Engagement ≠ endorsement. Privacy: https://t.co/AxsApipkIb
FDA Spokesperson - AR... @FDASpox_Archive
2K Followers 403 Following Assistant Commissioner for Media Affairs, U.S. Food and Drug Administration. - ARCHIVED ACCOUNT
HHS @HHSGov
1.7M Followers 40 Following Official account of the U.S. Department of Health & Human Services | Follow @SecKennedy | For latest news follow @HHSResponse | MAHA 🇺🇸
U.S. FDA Recalls @FDArecalls
643K Followers 15 Following Our posts are FDA Approved! Get notified about the U.S. Food and Drug Administration's recalls. Privacy Policy - https://t.co/AUq6FZbkjz
Dr. Stephen M. Hahn @SteveFDA
70K Followers 700 Following 24th Commissioner of Food and Drugs - @US_FDA This account is now archived.
Dr. Janet Woodcock @DrWoodcockFDA
14K Followers 64 Following Former Principal Deputy Commissioner at @US_FDA. This account is now archived.Trends for United States
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