FDA Drug Information

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#FDAapproves treatment for certain adult patients with von Hippel-Lindau (VHL) disease, an inherited disorder characterized by the formation of tumors and fluid-filled sacs in many different parts of the body: go.usa.gov/xFpZx
Does your child have an allergic reaction to bee stings 🐝, food allergies 🥜 & other allergens 🌼? Make sure they have emergency treatments on hand before headi#BackToSchoolool. How to prepare go.usa.gov/xF5XAUnMu
Learn about FDA’s recent oncology treatment approval of Keytruda (pembrolizumab) for high-risk early stage triple-negative breast cancer in the latest #FDADISCO podcast: go.usa.gov/xFpaK
#FDAapproves first treatment for adult patients with idiopathic hypersomnia (IH), a chronic sleep disorder: go.usa.gov/xFVhE
ICYMI: FDA launched a new crowdsourcing challenge that provides an opportunity for interested stakeholders to submit ideas for research using pooled analyses of pediatric clinical trial data directly to FDA’s scientific staff. Submit ideas here: ow.ly/vbFL50FHj4h
Women should not breastfeed when taking cholesterol-lowering statins because the medicine may pass into breast milk and pose a risk to the baby. If you require ongoing statin treatment, use infant formula or other alternatives. Learn more: go.usa.gov/xF5NC
We want to provide manufacturers with clear information to encourage the development of generic drugs, increasing competition, and potentially lowering drug costs.
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We know drug shortages are of great concern to the patients who rely on safe and effective medicines approved by FDA. twitter.com/FDAMedia/statu…
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Today, FDA approved the first generic of a popular drug used to help people quit smoking. Generic drug approvals like this one can help improve access to lower cost, safe, high quality medicines. go.usa.gov/xFmpH
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#FDAapproves first-line drug combination treatment for patients with advanced renal cell carcinoma (RCC): go.usa.gov/xFmfP and go.usa.gov/xFmfE
#DYK the FDA’s Bad Ad Program has a free 1-credit CE course regarding recognizing and reporting potentially false or misleading prescription drug promotion? Protect your practice against “Bad Ads”: fda.gov/BadAd #FDABadAd
Join us virtually on August 31 at 1 PM EST for the #CDERSBIA webinar on Promotional Submissions in eCTD Format – Grouped Submissions. Eligible for RAPS, SCORA, SQA, & ACRP CE credit. Register: go.usa.gov/xFNUn
FDA is extending the period for states to consider and sign the compounding memorandum of understanding (MOU) until Oct. 27, 2022: go.usa.gov/xFPBk
After this date, FDA intends to enforce the 5% limit on interstate distribution of compounded drugs by compounders in states that have not signed the MOU: go.usa.gov/xFPBX
We are celebrating #NationalBreastfeedingMonth with an interactive in-feed FAQ this Wednesday, August 11 at 1pm ET. If you or someone you know is breastfeeding or thinking about breastfeeding, join us to get answers to commonly asked questions. Follow @FDAWomen!
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Learn about FDA’s external crowdsourcing challenge to collect ideas about topics the public thinks FDA scientists should research using data from multiple pediatric clinical trials in the latest CDER Conversation: go.usa.gov/xFPrQ
Recess may be fun, but outdoor activities can expose your child to harmful UV rays. Don’t forget to add broad-spectrum sunscreen to your #BackToSchool shopping list! go.usa.gov/xFNDB
DYK: Women experience pain differently than men? Women often report more pain and are more likely to be prescribed pain medications. If you’re experiencing pain, talk to your healthcare provider about how to safely use pain medicines. Learn more here: go.usa.gov/xFYsm
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FDA issued a final guidance describing the considerations for using metastasis-free survival (MFS) as an endpoint in clinical trials for cancer drugs or biological products in patients with nonmetastatic castration-resistant prostate cancer: go.usa.gov/xFnuM
#FDAapproves treatment for patients 1 year of age and older with late onset Pompe disease, a genetic disorder involving lysosomal acid alpha-glucosidase (GAA) deficiency: go.usa.gov/xFnwA
FDA issued a final guidance to help manufacturers using near infrared (NIR)-based analytical procedures evaluate identity, strength, quality, purity, and potency of drugs: go.usa.gov/xFnEU
DYK: Some drugs can get into your breast milk and affect your baby? Here are 4 tips to help you learn more about how prescription and over-the-counter drugs might affect you and your baby: go.usa.gov/xF55f #WBW21 #NBM21
Learn about the role of real world evidence (RWE) in regulatory decision-making with the recent approval of an immunosuppressant drug in patients receiving lung transplantation in the latest From Our Perspective: go.usa.gov/xFNnJ
Register today for the #CDERSBIA webinar on August 25 to learn about the latest updates from CDER on policy and approaches toward manufacturing, supply chain, and inspections during #COVID19. Eligible for RAPS, SCORA, SQA, & ACRP CE credit. Register: go.usa.gov/xF5nQ
Today, FDA launched a new crowdsourcing challenge that provides an opportunity for interested stakeholders to submit ideas for research using pooled analyses of pediatric clinical trial data directly to FDA’s scientific staff. Submit ideas here: ow.ly/vbFL50FHj4h
#FDAapproves new treatment for adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy: go.usa.gov/xF9G8
There’s a lot of misinformation around, and you may have heard that it’s okay to take large doses of ivermectin to treat or prevent #COVID19. That is wrong. Here’s what you need to know about ivermectin ⬇️ go.usa.gov/xF9dH
Post-exposure prevention should be used in patients who are: ✅ not fully vaccinated or not expected to have an adequate response to the #COVID19 vaccine, AND ✅ exposed to an individual infected with #COVID19, AND ✅ the exposure meets close contact criteria per @CDCgov
Today, FDA updated the emergency use authorization (EUA) for REGEN-COV (casirvimab and imdevimab) to allow its use for post-exposure prevention of #COVID19 in adults and pediatric patients at high risk for progressing to severe disease: go.usa.gov/xFkEg
People of all skin colors are potentially at risk for sunburn & other harmful effects of UV radiation. Always protect yourself with these sun safety tips: go.usa.gov/x6exX #UVSafetyMonth
Thank you to the @EnergyCommerce subcommittee for the opportunity to testify today on neurodegenerative disease drug development and approval. energycommerce.house.gov/committee-acti…
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All stakeholders may start to recertify and re-enroll beginning August 16, 2021. To learn more, visit the Clozapine REMS Frequently Asked Questions (FAQs) webpage: go.usa.gov/xFK8Q
Prescribers, pharmacies/pharmacists, & wholesalers/distributors must re-certify or re-enroll in the Clozapine REMS by Nov 15, 2021, to continue prescribing, dispensing, or distributing the drug. Patients don’t need to take any actions – you’ll be re-enrolled by your prescriber.
Today, FDA approved a modification to the Clozapine Risk Evaluation and Mitigation Strategy (REMS) that will take effect on Nov 15, 2021. Learn about the changes & what health care professionals & other stakeholders must do to continue providing care: go.usa.gov/xFK8D
FDA has warned consumers of more than 1,000 products with undeclared drug ingredients over the past decade. Stores, websites, and online marketplaces, like Amazon, can do more to protect consumers from the sale of potentially dangerous and illegal FDA-regulated products. twitter.com/FDA_Drug_Info/…
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DYK: One of the most common symptoms of uterine fibroids is heavy menstrual bleeding? This #FibroidAwarenessMonth, learn about FDA approved drugs to treat heavy menstrual bleeding associated with fibroids: go.usa.gov/x6Auu
“Patient-focused drug development enables the delivery of therapeutics that have a meaningful impact on people’s quality of life and target what they consider the most important aspects of their disease.” –@FDACDERDirector Dr. Cavazzoni
“We understand the need for access to therapies when people with life-threatening diseases cannot participate in a clinical trial. This is why the Agency grants almost all individual patient expanded access requests.” – @FDACDERDirector Dr. Cavazzoni
.@FDACDERDirector Dr. Cavazzoni discusses the need to adopt additional innovative approaches for neurodegenerative diseases to bring new drugs to people who desperately need them.
.@FDACDERDirector Dr. Cavazzoni discusses how new therapies are brought to patients faster thanks to more efficient clinical trials and the use of expedited regulatory pathways.
WATCH LIVE NOW as @FDACDERDirector Dr. Cavazzoni testifies before @EnergyCommerce on a path forward for advancing treatments and cures for neurodegenerative diseases. go.usa.gov/xFBH7
Consumers should search for product information from sources other than sellers and ask a doctor for help distinguishing between reliable & questionable information. Our Tainted Product Database can also be used to identify potentially dangerous products: go.usa.gov/xFW8v
FDA continues to warn consumers to avoid certain products with hidden and potentially dangerous drug ingredients represented as conventional foods or dietary supplements for weight loss, body building, pain relief, sleep aids, and sexual enhancement: go.usa.gov/xFBzw
WATCH LIVE: At 11:00 AM, @FDACDERDirector Dr. Cavazzoni will testify before @EnergyCommerce where she will discuss a path forward for advancing treatments and cures for neurodegenerative diseases. @FDA_Drug_Info will tweet highlights from the testimony. go.usa.gov/xFBH7
Based on the totality of the scientific evidence now available from two clinical trials, FDA determined that baricitinib alone may be effective for treatment of certain #COVID19 patients. twitter.com/FDA_Drug_Info/…
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The EUA for baricitinib no longer requires that it be used in combination with remdesivir. See the revised fact sheets and FAQs for important information on dosing instructions, potential side effects, and drug interactions ⬇️ go.usa.gov/xF2zP
Today, FDA revised the emergency use authorization (EUA) for baricitinib to allow its use as stand-alone treatment of #COVID19 in hospitalized patients requiring supplemental oxygen, non-invasive & invasive mechanical ventilation, or ECMO: go.usa.gov/xFBDm
Patients and health care providers do not need to wait for a biosimilar product to “become” an interchangeable product. Biosimilars are safe and effective, just like the reference product to which they were compared. twitter.com/FDA_Drug_Info/…
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FDA also released new materials to help with understanding about biosimilar and interchangeable biosimilar products, including new fact sheets. go.usa.gov/xFZuH
Depending on state pharmacy laws, an interchangeable biosimilar may be substituted for the reference product at the pharmacy without consulting the prescriber.
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