FDA Drug Information
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Receive the latest drug information from the US FDA. Contact us at 1.855.543.3784 or druginfo@fda.hhs.gov. Privacy Policy - https://t.co/K2nAJlm94m.
Silver Spring
Joined July 2009
RT @US_FDA: Today FDA Commissioner @DrMakaryFDA announced that the nationwide shortage of sodium chloride 0.9% injection products, a form o….
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FDA’s Office of Pharmaceutical Quality has published their fiscal year 2024 Report on the State of Pharmaceutical Quality. The report includes select quality indicators and trends that provide insight into the quality of the U.S. drug supply.
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👉 View LEADER 3D educational content here:
fda.gov
The goal of LEADER 3D is to develop educational content based on the needs of rare disease drug development stakeholders.
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📢 Calling all rare disease drug innovators! FDA wants your feedback on CDER’s LEADER 3D initiative – our educational platform for rare disease drug development. What’s helpful? What’s missing? Let us know!. 🔗 Share your voice here:
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FDA expands the indication for Ajovy (fremanezumab-vfrm) injection as the first calcitonin gene-related peptide ligand for the preventive treatment of episodic migraine in children aged 6 & older & who weigh 45 kg (99 lbs) or more. Learn more:
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RT @US_FDA: The FDA is requiring safety labeling changes to all opioid pain medications to better emphasize and explain the risks associate….
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FDA published final guidance to help develop antibacterial drugs for serious bacterial diseases caused by drug-resistant organisms. This guidance provides regulatory flexibility to address urgent public health needs. #AntibacterialResistance #PublicHealth
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RT @US_FDA: The Agency is taking a bold step to protect Americans from dangerous, illegal opioids by recommending a scheduling action to co….
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FDA releases white paper on Selective Safety Data Collection. SSDC is the planned reduction in certain data collection for drugs with well-characterized safety profiles. White paper discusses trials that have used SSDC in oncology & cardiometabolic spaces.
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FDA approves first interchangeable rapid-acting insulin medication. Kirsty (insulin aspart-xjhz) is an interchangeable biosimilar to Novolog (insulin aspart). View the prescribing information:
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RT @US_FDA: Today, we announced the issuance of seven warning letters to companies illegally marketing products containing 7-hydroxymitragy….
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FDA invites you to attend a public workshop on the development of interchangeable biosimilar products. Register here for virtual or in-person participation:
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FDA invites you to attend the interim public meeting for the BsUFA III Regulatory Science Pilot Program. Register here:
fda.gov
The U.S. Food and Drug Administration (FDA) is hosting a hybrid in-person/virtual meeting on September 18, 2025, to meet the BsUFA III Commitment to review the progress of the pilot program’s aims,...
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The CDER Center for Clinical Trial Innovation (C3TI) demonstration project on Bayesian methods is expanding its scope to include pre-specified primary analysis and trial monitoring, in addition to its previous focus on supplementary analysis. Learn more:
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FDA releases final guidance on developing drugs for early Lyme disease. Guidance focuses on localized & disseminated disease; covers trial design, safety & efficacy; & aims to support drug development. Learn more: #LymeDisease #FDAGuidance.
fda.gov
Early Lyme Disease as Manifested by Erythema Migrans: Developing Drugs for Treatment
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FDA grants accelerated approval to a treatment for non-small cell lung cancer.
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FDA grants accelerated approval to a treatment for relapsed or refractory multiple myeloma.
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CDER released its 9th annual 2024 Drug Trials Snapshots report, which summarizes the demographic representation in the clinical trials that supported the 50 novel drugs approvals in 2024. 31,000 patients participated in these clinical trials. Learn more:
fda.gov
Drug Trials Snapshots: breaking down the what, how and why.
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