CDER - Biological Product Deviations
La FDA advierte que los medios de contraste basados en gadolinio (MCBG) se depositan en el cuerpo y exige una nueva clase de advertencias
FDA is requiring a new class warning and other safety measures for all gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI) concerning gadolinium remaining in patients’ bodies, including the brain, for months to years after receiving these drugs. Gadolinium retention has no
An FDA review found the side effects on mood, behavior, or thinking with the stop-smoking medicines Chantix (varenicline) and Zyban (bupropion) are lower than previously suspected. These risks still exist, but we believe the benefits of quitting smoking outweigh them.
FDA provides consumers and industry with safety, regulatory and availability information for various drugs by drug class. From A to Z. Topics include: acetaminophen, estrogen, insulin, opioids, statins, and weight-loss drugs.
Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process.
Frequently Asked Questions About Therapeutic Biological Products
This page provides summaries of past DSB Meetings. Each summary include DSCs posted since the last meeting, topics presented and discussed with the Board. Views expressed by non-CDER employees are those of the individual and not necessarily the opinion of his/her respective federal agency or Inst.
Discover FDA-approved products for anthrax preparedness and response. Get essential information on vaccines, treatments, and preventive measures to protect public health from bioterrorism threats like anthrax.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDSRIs); Updated Information
Oz mentioned risk coding and prior authorizations as areas he plans to examine in Medicare Advantage.
What does an engineer do? An engineer applies scientific principles to design, build, and test machines, systems, or structures to meet specific needs. They follow the steps of the engineering design process to ensure their designs work as planned while meeting a variety of requirements, including size, weight, safety, and cost. NASA hires several types […]
NASA’s Scientific Balloon Program has returned to Wānaka, New Zealand, for two scheduled flights to test and qualify the agency’s super pressure balloon technology. These stadium-sized, heavy-lift balloons will travel the Southern Hemisphere’s mid-latitudes for planned missions of 100 days or more. Launch operations are scheduled to begin in late March from Wānaka Airport, NASA’s […]
Airplane manufacturers running noise tests on new aircraft now have a much cheaper option than traditional wired microphone arrays. It’s also sensitive enough to help farmers with pest problems. A commercial wireless microphone array recently created with help from NASA can locate crop-threatening insects by listening for the sounds they make in fields. Since releasing […]
The International Space Station supports a wide range of scientific activities from looking out at our universe to breakthroughs in medical research, and is an active proving ground for technology for future Moon exploration missions and beyond. Firefly Aerospace’s Blue Ghost Mission-1 landed on the Moon on March 2, 2025, kicking off science and technology […]
Chem. Commun., 2025, Accepted Manuscript DOI: 10.1039/D4CC06799A, Communication Open Access This article is licensed under a Creative Commons Attribution 3.0 Unported Licence. Jing Chen, Paolo P. Pescarmona A series of novel dye-based organocatalysts was designed, synthesised and tested in the cycloaddition of CO2 to styrene oxide yielding styrene carbonate under mild reaction conditions (45 °C, 10 bar CO2).... The content of this RSS Feed (c) The Royal Society of Chemistry
The artist's flowing and geometric compositions stretch across walls and exterior facades. Do stories and artists like this matter to you? Become a Colossal Member today and support independent arts publishing for as little as $7 per month. The article Through Knotted Installations, Windy Chien Reinterprets the Hitching Post appeared first on Colossal.
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
RFK Jr.’s recent roundtable on regenerative medicine offers some worrying signs about his approach to regulating stem cells.
A polyelectrolyte-based wireless and drift-free iontronic sensor can measure prolonged loads in implants.
A DNN model reveals how sex-specific steroid variations influence aging, offering fresh insights into biological age prediction.
The longest sediment core (30 m) from a marine sinkhole provides an excellent cyclone-frequency record for the past 5700 years.
Boot sock sampling is an informative and valuable approach to assessing soil fecal contamination in informal settlements.
A polyvalent antibacterial vaccine could selectively kill tumor-associated bacteria to prevent cancer metastasis.
Linking ion migration with lattice dynamics offers a doping blueprint for stable, efficient perovskite devices.
A molecule-induced ripening control strategy enables perovskite QLEDs with a maximum peak EQE of 26.0% and a T50 of 10,587 hours.
Prior-adaptive probabilistic deep learning swiftly and reliably identifies all realistic structures from reflectometry data.
Advanced spike sorting based on self-supervised learning unveils the effects of Tau on hippocampal neuronal activity.
Spraying water microdroplets causes an electrical discharge between oppositely charged droplets that enables chemical reactions.
Genome-wide survey of human and mouse DMD tissues suggests EZH2’s role in satellite cells; its inhibition improves prognosis.
A crucial neuronal background current is regulated by the neurotransmitter release machinery.
Oral treatment with obeldesivir protects macaques from lethal infection with Ebola virus.
Stay informed on FDA updates and press announcements about recalls involving angiotensin II receptor blockers (ARBs) like valsartan and losartan. Discover key safety alerts, reasons for recalls, and the latest FDA actions to ensure drug safety and availability.
Find information on drug development, applications, submissions, manufacturing & quality, safety, labeling and more
Innovative drugs often mean new treatment options for patients and advances in health care for the American public.
Interviews with experts from FDA's Center for Drug Evaluation and Research (CDER) on priorities, projects, and initiatives.
Ophthalmic drug products, such as eye drops, pose a heightened risk of harm to users because drugs applied to the eyes bypass some of the body’s natural defenses. Any drug used in the eyes must be sterile to reduce the risk of infection. Eye drops are available by prescription or sold as OTCs.
Depending on your locale, equinoxes can be seen as harbingers of longer nights and gloomy weather, or promising beacons of nicer temperatures and more sunlight. Observing and predicting equinoxes is one of the earliest skills in humanity’s astronomical toolkit. Many ancient observatories around the world observed equinoxes along with the more pronounced solstices. These days, […]
Eight finalist teams participating in the 2025 NASA Gateways to Blue Skies Competition have been selected to present to a panel of judges their design concepts for aviation solutions that can help the agriculture industry. Sponsored by NASA’s Aeronautics Research Mission Directorate, this year’s competition asked teams of university students to research new or improved […]
Following the 3,000th orbit of NASA’s AWE (Atmospheric Waves Experiment) aboard the International Space Station, researchers publicly released the mission’s first trove of scientific data, crucial to investigate how and why subtle changes in Earth’s atmosphere cause disturbances, as well as how these atmospheric disturbances impact technological systems on the ground and in space. “We’ve […]
A NASA photographer captured a time-lapse image of the lunar eclipse and blood moon above the Space Environments Complex at NASA’s Neil Armstrong Test Facility in Sandusky, OH on March 14, 2025.
As part of NASA’s Artemis campaign, the Commercial Lunar Payload Services (CLPS) initiative, managed out of Johnson Space Center in Houston, is paving the way for conducting lunar science for the benefit of humanity. Through CLPS, NASA teams worked closely with commercial companies to develop a new model for space exploration, enabling a sustainable return […]
The phases of the lunar eclipse are visible in this time-lapse image of the Moon above the Space Environments Complex at NASA’s Neil Armstrong Test Facility in Sandusky, OH on March 14, 2025. Toward the middle of the Moon’s track through the sky, it appears red – this is the Blood Moon. One meaning of […]