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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. fda.gov/AboutDDI Silver Spring Joined July 2009-
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Don’t miss it! There's still time to register for our upcoming #CDERSBIA virtual webinar, Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval, on May 9 from 1 PM - 3 PM ET. Learn more and register today: fda.gov/drugs/news-eve…
Happy Earth Day! 🌎 🌱 ☀️ Help keep our planet healthy and our communities safe by bringing your unused and expired drugs to a drug take back location near you this Saturday, April 27, from 10 AM – 2 PM ET. Visit DEATakeBack.com for a collection site near you.
Happy #EarthDay! 🌎 🌱 ☀️ Help keep our planet healthy and communities safe by bringing your unused and expired drugs to a drug take back location near you this Saturday, April 27, from 10 AM – 2 PM ET. Find a collection site near you: dea.gov/takebackday #TakeBackDay
#FDAapproves a nasal spray for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients: accessdata.fda.gov/drugsatfda_doc…
✅ Did you catch the Overview of the FDA’s Product-specific guidance program at the Generic Drugs Forum? 📣 #DYK that we have a webinar on April 25th dedicated to just product-specific guidances? Become an expert. Register now ➡️ fda.gov/drugs/news-eve…
📚NEW course available for Rheumatologists, Ophthalmologists, Dermatologists & Nurses on "Care Plans with Biosimilars" to enhance treatment of immunological conditions & patient discussions about #biosimilars. Enroll now: bit.ly/3IL6f6M #Medscape
Happy #NationalLookAlikeDay! Did you know that generic drugs may not look like their brand-name counterparts, but they are just as safe and effective? Don't judge a pill by its cover. Learn more ➡️ fda.gov/drugs/frequent…
FDA published the final guidance for industry, Pharmacokinetics in Patients with Impaired Renal Function, and recently published accompaniments to the guidance document: 📘 Guidance Snapshot: fda.gov/media/177769/d… 🔊 Guidance Recap Podcast: fda.gov/media/177771/d…
📢 Calling patient groups in the #RareDiseases community! Share your resources to help other patient group leaders get started with research. Selected resources will be included on the NCATS Toolkit website. Learn how to submit: go.nih.gov/ehRz9yQ 1/2
This CDER Conversation, Christopher Diamant, J.D., regulatory counsel, Office of Medical Policy, discusses how Patient Medication Information proposed rule could help provide patients with clear instructions to help them take their medications as intended: fda.gov/drugs/cder-con…
Many drug companies participate in Expanded Access and are required to state if they do so on their website. OCE's Project Facilitate can help the oncology care team find a point of contact for a company. fda.gov/about-fda/onco… #ProjectFacilitate
Discover insights and enhance your understanding of drugs, devices, & biologics from FDA regulatory experts at the REdI Annual Conference 2024: Innovation in Medical Product Development. Attend in person or online on May 29-30, 2024. ✅ Register today: fda.gov/drugs/news-eve…
#FDAapproves a fluorescent imaging drug for adults with breast cancer that is administered by injection before lumpectomy surgery to assist in the detection of cancerous tissue: fda.gov/drugs/news-eve…
⚠️ CDC & partners are investigating reports of harmful reactions linked to counterfeit “Botox." See a doctor immediately if you have symptoms, such as blurry vision, drooping eyelids, or difficulty swallowing: bit.ly/4aU54hg
📢 #ICYMI: There's still time to register for our upcoming #CDERSBIA virtual webinar, Facilitating Generic Drug Product Development through Product-Specific Guidances, on April 25 from 1 PM - 4:00 PM ET. Learn more and register today: fda.gov/drugs/news-eve…
Join @FDAHealthEquity Wednesday at 11 a.m. ET for a virtual panel discussion. The panel will discuss ongoing work to improve clinical trial participation among racial and ethnic minority, and other communities. Register at ⬇️ fda.gov/consumers/mino… #NMHM2024
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44K Followers 303 Following Committed to ensuring a healthier life for every family. News & updates from FDA Center for Tobacco Products. Privacy Policy - https://t.co/o45IXnOmMwDr. Robert M. Califf @DrCaliff_FDA
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5K Followers 1K Following FDA's Medical Countermeasures Initiative (MCMi) - protecting national health and security. Privacy policy - https://t.co/ojjgL0hX7UCDER’s long-standing efforts to embed innovation in clinical trial design and conduct into our regulatory work have been crucial in bringing new therapies to areas of unmet medical need.
Today, we announced the launch of the CDER Center for Clinical Trial Innovation (C3TI). C3TI’s mission is to promote CDER clinical trial innovation activities through enhanced communication and collaboration, both internally within CDER and externally: fda.gov/drugs/drug-saf…
Congratulations to the Office of Communications (OCOMM) for all the tremendous work they do to disseminate critical health messages, combat misinformation, and empower Americans to make informed decisions for themselves and their loved ones.
CDER's Office of Communications issued its 2023 Annual Report which highlights key communications and actions during the year to protect consumers and ensure they are provided with accurate, transparent, and dynamic communications: bit.ly/CDEROCOMM
Thank you to the OPQ staff for their dedicated work in assessment, inspection, research, surveillance, & policy covering every type of human drug including new drugs, biologics, biosimilars & generics, and over-the-counter drugs.
Today, FDA’s Office of Office of Pharmaceutical Quality (OPQ) published its 2023 Annual Report, which details the many ways OPQ assures the availability, safety, and efficacy of every dose of medicine available to the American public: fda.gov/media/177470/d…
Have you ever picked up a prescription at the pharmacy 💊 and later realized you have questions about something in the directions or warnings? Get answers by calling ☎️ your local pharmacist or the FDA’s drug information pharmacists at 301-796-3400.
Be like the penguin! Keep an eye out for health fraud. 🐧 🔎 #NCPW2024 #SlamTheScamChat
Check out FDA’s medication health fraud resources, including how to buy medications safely online, how to identify counterfeit medications and products with hidden ingredients, and a searchable product database: fda.gov/drugs/buying-u… #SlamTheScamChat #NCPW2024
A5: Be Smart. Be Aware. Be Careful & don’t fall for #HealthFraud scams! These scams waste money, can delay proper diagnosis & treatment, or can cause serious or fatal injuries. Check our website for the latest #HealthFraud info: fda.gov/consumers/heal… #NCPW2024 #SlamTheScamChat
Q5: What resources do you have that can help people stay safe from scams? #SlamTheScamChat #NCPW2024
Q5: What resources do you have that can help people stay safe from scams? #SlamTheScamChat #NCPW2024
Q4: What common tactics do you expect to see from scammers in 2024? #SlamTheScamChat #NCPW2024
A2: Populations especially vulnerable to #healthfraud are those experiencing health crises looking for hope & a cure as well as ethnic groups who may not speak or read English well, or who hold certain cultural beliefs: fda.gov/consumers/cons… #SlamTheScamChat #NCPW2024
Q2: Who experiences scams and fraud in the U.S.? #SlamTheScamChat #NCPW2024
If you see something, say something about #HealthFraud! #SlamTheScamChat #NCPW2024
A3: @FDA_ORA encourages #HealthFraud reporting of all kinds, from encountering scam products to experiencing adverse events, and provides multiple ways for consumers to report scams: fda.gov/safety/medwatc… #SlamTheScamChat #NCPW2024
Q3: How can you report a scam? What options do you have? #SlamTheScamChat #NCPW2024
Who do #HealthFraud scams target? EVERYONE! Scammers promote health products with savvy marketing, often using tactics that target specific populations via the web, social media, & messaging apps, that promise to help many common health issues:fda.gov/consumers/heal… #NCPW2024
Q2: Who experiences scams and fraud in the U.S.? #SlamTheScamChat #NCPW2024
Q2: Who experiences scams and fraud in the U.S.? #SlamTheScamChat #NCPW2024
A1:🚩💳 Red flags for SNAP scams: - Unauthorized charges & alerts on EBT acct. - Suspicious calls, texts, or emails requesting EBT card or PIN # - Offers for prizes in exchange for EBT info Unsure? Contact your local SNAP office to verify. #SlamTheScamChat #NCPW2024
Let’s get started with the #SlamTheScamChat! Q1: What are some red flags when encountering a scam? 🚩 #NCPW2024
A1: Phrases such as “Quick Fix” & “One Product Does It All” are tip-offs for #HealthFraud scams! These products can’t deliver on their baseless promises & they could cause serious injury or death. Find more #HealthFraud tip-offs: fda.gov/consumers/cons… #SlamTheScamChat #NCPW2024
Let’s get started with the #SlamTheScamChat! Q1: What are some red flags when encountering a scam? 🚩 #NCPW2024
Welcome to the 2024 #SlamTheScamChat! Follow the hashtag to learn how to stay safe from scams with government experts. #NCPW2024 Together, we will find out: 🚩 How to spot red flags 📈 Know this year’s trends 👏 Take action against scams.
We are excited to join the chat today for #NCPW2024! #SlamTheScamChat
📣Today! Chat with @FDA_ORA & @USAGov about common #HealthFraud scams and how to take action against them at 3:00 PM ET. Follow the hashtag #NCPW2024 & #SlamTheScamChat to learn how to avoid health fraud scams!
A robust informed consent process not only helps individuals make the right decisions for themselves, but also strengthens the broader clinical trial enterprise, which is critical to the development of important and potentially life-saving therapeutics.
Participation in FDA-approved clinical trials is voluntary, but individuals must receive consent-related information in a clear, comprehensible way to make an informed decision on whether they wish to join the clinical trial.
FDA is protecting prospective clinical trial or study participants by providing recommendations to make consent information more understandable in the latest #FDAVoices by @FDACDERDirector Dr. Cavazzoni & FDA Chief Medical Officer, Hilary Marston: fda.gov/news-events/fd…
The FDA is committed to advancing treatment options for patients with rare diseases & engaging stakeholders to help address the challenges associated with rare disease research and, when applicable, incorporate the patient perspective in medical product development & regulation.
Learn how the FDA is helping to deliver meaningful advances to rare disease patients in the latest #FDAVoices article: fda.gov/news-events/fd…