FDA Drug Information

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Today, we announced that we issued three warning letters to companies for introducing mole and skin tag removal products into interstate commerce that are unapproved new drugs, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). fda.gov/news-events/pr…
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There are different types of medications that are safe and effective to treat #psoriasis, such as biosimilars. Learn more about biosimilars and how they may provide patients with more access to important treatments: go.usa.gov/xJzkH
Don't miss our keynote speaker, FDA Principal Deputy Commissioner @DrWoodcockFDA at #CDERSBIA’s conference in collaboration with @USAIDGH & @USPharmacopeia. Join Aug 16-18 to learn about FDA's role in international regulatory harmonization. Register at: fda.gov/drugs/news-eve…
🎧 Learn about FDA’s recent oncology treatment approval of Xalkori (crizotinib) in the latest#FDADISCOO podcast:fda.gov/media/160545/d…Gd
Today, we approved the first treatment specifically for patients with unresectable (unable to be removed) or metastatic HER2-low breast cancer. HER2-low breast cancer subtype is a newly defined subset of HER2-negative breast cancer. fda.gov/news-events/pr…
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Today, FDA published a new web page to highlight recent FDA actions and activities related to complex generics as part of FDA’s continued commitment to ensuring Americans have access to safe, effective, high-quality, and more affordable generic drugs: fda.gov/drugs/generic-…
Join FDA and @complexgenerics for a free public workshop on October 27-28 on Best Practices for Utilizing Modeling Approaches to Support Generic Product Development Public Workshop. Register here: complexgenerics.org/modeling-appro…
This workshop will engage regulatory, industry and academic experts in the field of modeling and simulation to discuss the opportunities and best practices for incorporating modeling and simulation approaches into generic drug development programs.
Are you a health care professional reporting observed or suspected adverse events on your patient’s behalf? Check out our new Drug Info Rounds video for information to make reporting to MedWatch easier than ever: fda.gov/drugs/fda-drug…
ICYMI: Join #CDERSBIA's Best Practices for Topical Generic Product Development and ANDA Submission webinar, Aug 11 @ 9:30 AM ET, to learn about resources for implementing efficient in vitro characterization-based BE approaches for such products. Register: fda.gov/drugs/news-eve…
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/xF5XAj5Ty
The correct answer is all of the above. Always ask your health care provider if it’s safe to breastfeed if you’re taking medications or supplements. Check out these tips to learn more about how these products might affect you & your baby: go.usa.gov/xJzBd
ICYMI: Join us Aug 10 @ 1PM ET for #CDERSBIA's webinar on Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use. Register: fda.gov/drugs/news-eve…
#FDAapproves Cimerli (ranibizumab-eqrn), the first interchangeable biosimilar to Lucentis (ranibizumab injection): accessdata.fda.gov/drugsatfda_doc…
#FDAapproves treatment for psoriatic arthritis for pediatric patients 6 years and older: accessdata.fda.gov/drugsatfda_doc…
PSGs reflect FDA’s current thinking for developing generic drug products and generating evidence to support FDA approval of these products, which can help facilitate generic drug development and FDA assessment.
Today, FDA published 48 product-specific guidances (PSGs) – 18 for complex generic drug products, 28 for products with no approved generics, and 29 new PSGs for medications that treat conditions such as HIV, severe hypoglycemia, and rare genetic diseases: accessdata.fda.gov/scripts/cder/p…
World Breastfeeding Week #WBW2022 Quiz: Before you start breastfeeding, you should ask your health care provider about taking which of the following products?
🔊 New! FDA Drug Safety Podcast on Copiktra (duvelisib):fda.gov/drugs/drug-saf…L View prescribing information:accessdata.fda.gov/drugsatfda_doc…ct
Learn about current issues relating to manufacturing and quality assurance at the @PDAonline / FDA Joint Regulatory Conference on September 12-14 in Washington, DC. Register here ➡️ fda.gov/drugs/news-eve…
Today, we’re providing an update on our multipronged response to monkeypox in the United States, including our efforts in the areas of diagnostics, vaccines, and therapeutics. fda.gov/news-events/pr…
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La FDA aconseja a los consumidores que no compren ni usen Lipopastilla + Gold Max, un producto que se comercializa y vende para bajar de peso, debido a ingredientes farmacológicos ocultos: fda.gov/drugs/medicati…
Thank you to OGD’s Global Affairs program, and congratulations to all who helped form the Generic Drug Cluster. @EMA_News @GovCanHealth @MHRAgovuk @Swissmedic_ @IsraelMOH twitter.com/FDA_Drug_Info/…
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FDA advises consumers not to purchase or use Honeymoon Exclusive For Men & Women, a product promoted for sexual enhancement, due to hidden drug ingredients: fda.gov/drugs/medicati…
Today, FDA’s Office of Generic Drugs published its first progress report on the activities and accomplishments of the Global Generic Drug Affairs program’s Generic Drug Cluster: fda.gov/drugs/generic-…\
The Generic Drug Cluster was established as a multi-country forum for the world’s leading regulatory agencies to achieve a common understanding of each agency’s regulatory requirements and to increase scientific information sharing and alignment. fda.gov/drugs/generic-…
#DYK people living with chronic Hepatitis B virus (HBV) can spread the virus to others, even if they do not feel or look sick themselves? Learn how it’s spread, the symptoms, and treatments ➡️ go.usa.gov/xuS5e #WorldHepatitisDay
#FDAapproves treatment for patients aged 5 years & older with active systemic lupus erythematosus (SLE) and active lupus nephritis who are receiving standard therapy: accessdata.fda.gov/drugsatfda_doc…
Check out the Guidance Snapshot and the recap podcast with the authors to learn more: fda.gov/media/160256/d…
FDA issues guidance to facilitate drug development for neonates by providing recommendations for conducting clinical pharmacology studies in this vulnerable population: fda.gov/regulatory-inf…
Today, FDA announced a shelf-life extension for four lots of Paxlovid (nirmatrelvir tablets and ritonavir). To learn more & see a table of the affected lot numbers, visit: fda.gov/emergency-prep…
🎧 Learn about FDA’s recent oncology treatment approval of Tafinlar (dabrafenib) in combination with Mekinist (trametinib) in the latest#FDADISCOO podcast:fda.gov/media/160180/d…Db
ICYMI: Check out the new “Q&A with FDA” podcast ft. Dr. Farley, Director of CDER’s Office of Infectious Diseases, answer questions about Paxlovid (nirmatrelvir and ritonavir) & COVID-19. 🎧 Listen to the full podcast ➡️fda.gov/media/160003/d…WR
It’s not just for the beach. 🏖️ Use sunscreen 🧴 anytime you’re going to be out in the sun. Even on an overcast day, up to 80% of the sun’s UV rays can get through the cloudsfda.gov/consumers/cons…GU #UVSafetyMontht09
Looking for free 1-hr Continuing Education (CE) credit on FDA drug regulation and medication safety topics? Check out our new on-demand Home Study CE webinars for HCPs: fda.gov/about-fda/fda-…
FDA advises consumers not to purchase or use Lipopastilla + Gold Max, a product promoted and sold for weight loss due to hidden drug ingredients: fda.gov/drugs/medicati…
Reading the product label is the most important part of taking care of yourself when using over-the-counter (OTC) drugs. This #InternationalSelfCareDay, learn how to read the “Drug Facts” label on OTC drugs to help you compare & select products: go.usa.gov/xuS5F
CDC, in partnership with FDA, has made it easier to provide TPOXX to people with #monkeypox. The streamlined process reduces the number of required forms, patient samples, and photos & gives patients the option to see their doctor virtually.  More: bit.ly/3osCPzS.
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Today’s draft guidance lays out how we intend to leverage this tool to advance our mission as we further incorporate modernized approaches to protecting public health.
FDA issued a draft guidance on the expanded use of remote regulatory assessments (RRAs) to provide transparency to stakeholders about how RRAs may be used and to promote consistency in the way RRAs are conducted: fda.gov/news-events/pr… View guidance: fda.gov/media/160173/d…
FDA announces proposed rule: Revising the National Drug Code Format and Drug Label Barcode Requirements, to minimize the impact of FDA running out of ten-digit national drug codes (NDCs) by adopting a single, uniform 12-digit format for FDA-assigned NDCs: fda.gov/drugs/drug-app…
FDA is issuing this guidance as part of the Drug Competition Action Plan. fda.gov/drugs/guidance…
This guidance provides information and recommendations regarding potential courses of action for an ANDA applicant after issuance of a CRL, as well as the actions that FDA may take if the applicant fails to respond to that CRL.
Today, FDA issued a guidance to assist applicants of abbreviated new drug applications (ANDAs) in responding to complete response letters (CRLs) from FDA: fda.gov/regulatory-inf…
Dr. Farley, Director of CDER’s Office of Infectious Diseases, explains how authorizing state-licensed pharmacists to prescribe Paxlovid (nirmatrelvir & ritonavir) could broaden access to patients. 🎧 Listen to the full podcast ➡️fda.gov/media/160003/d…Wd
FDA is publishing this guidance as part of the Drug Competition Action Plan, which aims to facilitate more generic competition, promote patient access, and improve the economics of developing generic medicines. fda.gov/drugs/guidance…
This guidance is part of FDA’s continued efforts to improve transparency, provide helpful information to regulated industry and the public, and provide answers to commonly asked questions FDA has received regarding the Orange Book.
Today, FDA finalized a guidance to assist prospective drug product applicants, drug product applicants, and approved application holders in utilizing the Orange Book: fda.gov/regulatory-inf…
Join #CDERSBIA's Best Practices for Topical Generic Product Development and ANDA Submission webinar, Aug 11 @ 9:30 AM ET, to learn about resources for implementing efficient in vitro characterization-based BE approaches for such products. Register: fda.gov/drugs/news-eve…
🎧 Learn about FDA’s recent oncology treatment approval of Breyanzi (lisocabtagene maraleucel) in the latest#FDADISCOO podcast:fda.gov/media/160058/d…8y
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