#FDAapproves first generic of Radicava (edaravone): accessdata.fda.gov/scripts/cder/o…

Fentanyl, a potent drug, is often disguised in fake pills mimicking Oxycontin, Percocet, and Xanax. Despite its medical uses, it's odorless, tasteless, and hard to detect, posing a grave risk to unsuspecting users. #FentanylAwarenessDay #JustKnow #OnePillCanKill #TipTuesday

𝗧𝗼𝗱𝗮𝘆 𝗶𝘀 𝗡𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗙𝗲𝗻𝘁𝗮𝗻𝘆𝗹 𝗔𝘄𝗮𝗿𝗲𝗻𝗲𝘀𝘀 𝗗𝗮𝘆. illegal fentanyl is a significant factor behind the recent surge in US drug overdose fatalities. #JustKNOW #NationalFentanylAwarenessDay

Know the facts ➡️ dea.gov/fentanylawaren…

This Public Service Recognition Week, we express our appreciation to all the dedicated CDER employees who keep Americans healthy by ensuring access to safe, effective, and high-quality medicines. Your individual work helps CDER accomplish its critical public health mission.

Join me as I offer opening remarks at this hybrid workshop with FDA’s Rare Diseases Team, NCATS, and Foundation for FDA focusing on the use of natural history studies and registries in the development of rare disease treatments.

What is FDA Oncology's Project 5 in 5?
⏩ OCE Director Dr. Richard Pazdur explains how 𝘆𝗼𝘂 can take part in crowdsourcing to ultimately select 5 clinically relevant questions to be answered in pragmatic clinical trials.
shareyourvoice.ideascalegov.com/c/
#OCEProject5in5

Big thank you to all the public servants out there that work every day to make #GovPossible , including FDA employees. We appreciate your commitment and dedication to keeping Americans safe, healthy, and thriving.

#PSRW

#ICYMI : FDA’s Rare Diseases Team, NCATS, and Foundation for FDA invite you to a hybrid public workshop on May 13, 2024, on the use of natural history study and registry data in rare disease drug development programs.

Learn more: fda.gov/drugs/news-eve…

We're in Anaheim for the Association of Clinical Research Professionals (ACRP) Annual Conference #ACRP2024 ! Stop by Exhibit #409 to learn about FDA trial guidances and regulations.

🎧 Did you know that switching between biosimilars and their reference products is not associated with any major safety concerns? Learn more in this Q&A with FDA podcast with Dr. Sarah Yim, Director of FDA’s Office of Therapeutic Biologics & Biosimilars: fda.gov/media/178186/d…

Attn: #RareDisease Community NCATS needs your help to educate and empower patient groups! Share your resources for inclusion in the NCATS Toolkit & help group leaders build their community and advance research. 🌍🤝 ncats.nih.gov/research/resea…

FDA is providing an update to this alert to include images of authentic, FDA-approved Botox products: fda.gov/drugs/drug-saf…

FDA-approved Botox products display the active ingredient as “OnabotulinumtoxinA” on the outer carton and vial, and is not made in 150 unit doses.

Protect your little ones from sunburn this summer! Babies under 6 months shouldn't wear sunscreen, so to prevent sunburn:

⛱️ keep them in the shade
👒 dress them in lightweight clothing and a wide brim hat
🕙 keep them out of the sun between 10 & 2

fda.gov/consumers/cons…

FDA is announcing a public meeting to discuss approaches to developing drugs to treat the negative symptoms of schizophrenia and disseminate important regulatory considerations for programs designed to evaluate these drugs: fda.gov/drugs/news-eve…

Ever heard of FDA's Office of Translational Sciences (OTS)? OTS performs drug regulatory reviews, actively engages in regulatory science research, and facilitates research activities.

Check out their annual report to see what they accomplished in 2023: fda.gov/media/178174/d…

May is #ALSAwareness Month. ALS is a rare disease that attacks & kills the nerve cells that control voluntary muscles, like the ones you use to chew, walk, talk, and breath.

Check out our five-year action plan for rare neurodegenerative diseases like ALS: fda.gov/media/159372/d…

This #NationalHonestyDay , beware of potentially counterfeit medicines. If you:

💻 Bought the product online
❓ Noticed the packaging looks different
🤒 Experienced an unusual side effect

The product may not be authentic.

Learn more how to report it: fda.gov/drugs/buying-u…