$GFY News

Last published 2y ago

2y agoCAH GFYFDA Roundup: June 21, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published final guidance titled Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection. This guidance defines the types of behaviors (actions, inactions, and circumstances) that FDA considers to constitute delaying, denying, or ...
2y agoGFYFDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After Extensive Scientific ReviewFDA Press ReleasesFollowing an extensive scientific review, the U.S. Food and Drug Administration today authorized the marketing of four e-cigarette products in the United States through the premarket tobacco product application (PMTA) pathway. The FDA issued marketing granted orders to NJOY LLC for four menthol-flavored e-cigarette products – NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod Menthol 5%, NJOY DAILY Menthol 4 ...
2y agoGFYFDA Expands Approval of Gene Therapy for Patients with Duchenne Muscular DystrophyFDA Press ReleasesToday, the U.S. Food and Drug Administration expanded the approval of Elevidys (delandistrogene moxeparvovec-rokl), a gene therapy for the treatment of Duchenne muscular dystrophy (DMD) for ambulatory and non-ambulatory individuals 4 years of age and older with DMD with a confirmed mutation in the DMD gene. Elevidys was previously approved under accelerated approval for ambulatory individuals 4 th ...
2y agoDLTR GFYFDA Roundup: June 18, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a request for input about patient safety associated with certain medical software functions excluded from the medical device definition. This input will help the FDA develop the 2024 report on the risks and benefits to health of non-device software functions. Pl ...
2y agoMMSI GFYFDA Roundup: June 14, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued a proposed exemption for certain cottage cheese products from the requirements of the Food Traceability Rule. The proposal would exempt Grade “A” cottage cheese that appears on the Interstate Milk Shippers List from the requirements of the rule. Today, the FDA anno ...
2y agoGFYBiden-Harris Administration Announces National Strategy to Reduce Food Loss and Waste and Recycle OrganicsFDA Press ReleasesToday, the U.S. Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), and the U.S. Environmental Protection Agency (EPA) announced the “National Strategy for Reducing Food Loss and Waste and Recycling Organics” as part of President Biden’s whole-of-government approach to tackle climate change, feed people, address environmental justice, and promote a circular economy. The ...
2y agoGFYFDA Roundup: June 11, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an advisory warning consumers and retailers to not eat, sell, or serve any flavor of Diamond Shruumz- Brand Chocolate Bars, Cones, and Gummies. The FDA and CDC, in collaboration with America’s Poison Centers and state and local partners, are investigating a series ...
2y agoGFYJustice Department and FDA Announce Federal Multi-Agency Task Force to Curb the Distribution and Sale of Illegal E-CigarettesFDA Press ReleasesThe U.S. Department of Justice (DOJ) and the U.S. Food and Drug Administration (FDA) today announced the creation of a federal multi-agency task force to combat the illegal distribution and sale of e-cigarettes. Along with the FDA and the Justice Department, the task force will bring together multiple law enforcement partners, including the Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF) ...
2y agoGFYFDA Roundup: June 7, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced that it has advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the United States should be monovalent (single strain) JN.1 vaccines to more closely match currently circulating SARS ...
2y agoGFYFDA Roundup: June 4, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published When We Work Together, Hand in Glove with Our Partners, We Can Overcome Any Barrier: A Conversation with EMA's Emer Cooke. The interview is the latest in the FDA’s blog series From a Global Perspective. These are occasional thought pieces on international topics ...
2y agoGFYFDA Roundup: May 31, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA approved mRESVIA (Respiratory Syncytial Virus Vaccine) for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older. mRESVIA is an mRNA-based vaccine that is manufactured by Moderna Moder ...
2y agoGFYFDA’s Reorganization Approved for Establishing Unified Human Foods Program, New Model for Field Operations and Other Modernization EffortsFDA Press ReleasesThe U.S. Food and Drug Administration reached a significant milestone with approval of its reorganization involving the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations and other significant modernization efforts. The reorganization implementation is currently targeted for Oct. 1, 2024, notably enhancing the agency’s ability to oversee and protect t ...
2y agoSBUX SYY GFYFDA, USDA, EPA enhance efforts to reduce food loss and waste, welcome USAID to interagency collaborativeFDA Press ReleasesThe U.S. Food and Drug Administration announced today the signing of a formal agreement with the U.S. Department of Agriculture (USDA) and the U.S. Environmental Protection Agency (EPA) to renew their Federal Interagency Collaboration to Reduce Food Loss and Waste (FIFLAW). Additionally, the U.S. Agency for International Development (USAID) joined the collaboration as an important federal partner ...
2y agoISRG GFYFDA Roundup: May 28, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA announced it had opened a new period for applications for grants to support the development and potential approval or conditional approval of new animal drugs intended to treat uncommon diseases (minor uses) in major species (horses, dogs, cats, cattle, pigs, turkeys ...
2y agoAMGN CBPO GFYFDA Approves First Interchangeable Biosimilar for Two Rare DiseasesFDA Press ReleasesToday, the U.S. Food and Drug Administration approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. Bkemv is approved for the following treatment indications, which are also currently approved for Soliris: the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; and the treatment of patie ...
2y agoGFYFDA Roundup: May 24, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA announced that Medline Industries, LP, a firm marketing and distributing plastic syringes made in China within the U.S., initiated a recall to stop using affected products which includes unauthorized plastic syringes made in China. Additionally, on Tuesday, the FDA ...
2y agoGFYFDA Roundup: May 21, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced that registration is open for the two-day virtual public meeting, "FDA’s Fifth Online Controlled Substances Summit." The goal of this summit, hosted in partnership with the Reagan-Udall Foundation for the FDA, is to identify innovative solutions to reduce the il ...
2y agoGFYFDA Roundup: May 17, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA granted accelerated approval to tarlatamab-dlle (Imdelltra, Amgen, Inc.) for extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. The prescribing information for tarlatamab-dlle includes a Boxed Warning f ...
2y agoGFYFDA Roundup: May 14, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA’s Office of Science and Engineering Laboratories launched an improved online Regulatory Science Tool (RST) Catalog to enhance search and browse capability as well as allow for long-term growth in published tools. The RST Catalog is now organized by research program an ...
2y agoGFYFDA Roundup: May 10, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA provided information on how to safely charge hearing aids, glucose monitors, insulin pumps, and other medical devices to avoid overheating. Medical devices with rechargeable batteries meet important medical needs, but if they are not charged properly, they can overh ...
2y agoGFYFDA Issues Final Guidance to Clarify “Remanufacturing” of Devices that Need Maintenance or RepairFDA Press ReleasesToday, the U.S. Food and Drug Administration issued final guidance to provide the medical device industry clarity on the definition of “remanufacturing” for reusable devices needing maintenance or repair. The final guidance seeks to ensure that there is consistency regarding what constitutes remanufacturing activities and to promote a better understanding of applicable federal law and regulations ...
2y agoGFYEPA, FDA, and USDA Issue Joint Regulatory Plan for BiotechnologyFDA Press ReleasesIn response to President Biden’s Executive Order 14081, “Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy,” the U.S. Environmental Protection Agency (EPA), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) have developed a plan to update, streamline, and clarify their regulations and oversight m ...
2y agoGFYFDA Roundup: May 7, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a meeting of the Psychopharmacologic Drugs Advisory Committee on June 4 to discuss a new drug application for midomafetamine (MDMA) capsules, submitted by Lykos Therapeutics, for the treatment of post-traumatic stress disorder. The committee will discuss the ove ...
2y agoGFYFDA Roundup: May 3, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced the availability of draft guidance for industry (GFI) #290 (VICH GL61) entitled “Pharmaceutical Development” for veterinary drug products. This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Re ...
2y agoGFYFDA Clarifies Approach to Genomic Alterations in AnimalsFDA Press ReleasesToday, the U.S. Food and Drug Administration took important steps to advance the FDA’s regulatory process for intentional genomic alterations (IGAs) in animals. The updated guidance documents underscore the agency’s commitment to further modernize its approach to evaluating and supporting the development of innovative animal and veterinary products to increase regulatory flexibility, predictabilit ...
2y agoCAH GFYFDA Roundup: April 30, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and Effective Biosimilars,” by Sarah Yim, Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., and Patrizia Cavazzoni, M.D., Direc ...
2y agoGFYFDA to Hold Listening Session as Part of Broader Work to Optimize Use of, and Processes for, Advisory CommitteesFDA Press ReleasesToday, the U.S. Food and Drug Administration announced it will host a listening session in June as part of its broader work to optimize the use of, and processes for, advisory committees. This virtual public meeting will focus on the composition of advisory committees, ways to improve the experience for members serving on committees and ways to ensure public awareness and understanding of the role ...
2y agoGFYFDA Takes Action Aimed at Helping to Ensure the Safety and Effectiveness of Laboratory Developed TestsFDA Press ReleasesToday, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised for many years. LDTs are in vitro diagnostic products (IVDs) that the FDA has described as intended for clinical use and designed, manufactured a ...
2y agoCAH GFYFDA Roundup: April 26, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published the FDA Voices: “A Milestone in Facilitating the Development of Safe and Effective Biosimilars,” by Sarah Yim, Director of the Office of New Drugs’ Office of Therapeutic Biologics and Biosimilars, Hilary Marston, M.D., M.P.H., and Patrizia Cavazzoni, M.D., Direc ...
2y agoGFYFDA Approves New Treatment for Uncomplicated Urinary Tract InfectionsFDA Press ReleasesToday, the U.S. Food and Drug Administration approved Pivya (pivmecillinam) tablets for the treatment of female adults with uncomplicated urinary tract infections (UTIs) caused by susceptible isolates of Escherichia coli, Proteus mirabilis and Staphylococcus saprophyticus. “Uncomplicated UTIs are a very common condition impacting women and one of the most frequent reasons for antibiotic use,” said ...
2y agoGFYFDA Roundup: April 23, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA announced a new initiative aimed to help reimagine the home environment as an integral part of the health care system. The Home as a Health Care Hub is intended to enable solutions that seamlessly integrate medical devices and health care, prevention and wellness into peo ...
2y agoGFYFDA Roundup: April 19, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA posted a safety communication to inform the public and healthcare providers that the agency has required and approved labeling changes to the U.S. Prescribing Information (USPI) for all licensed BCMA-directed and CD19-directed genetically modified autologous CAR-T c ...
2y agoGFYFDA Roundup: April 16, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA’s Center for Devices and Radiological Health (CDRH) announced the unveiling of a new public dataset designed to help assist chemistry labs in ensuring the robustness of chemical characterization methods used to assess the biocompatibility of medical devices. This dataset ...
2y agoGFYFDA Roundup: April 12, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA will reopen the comment period for 60 days for the draft guidance “Recommendations for Collecting Representative Samples for Food Testing Used as Evidence for Release of Certain Fish and Fishery Products Subject to Detention Without Physical Examination (DWPE) and Removal ...
2y agoGFYFederal Court Enters Consent Decree Against Philips Respironics Following Recall of Certain Sleep Therapy MachinesFDA Press ReleasesToday, the U.S. District Court for the Western District of Pennsylvania entered a consent decree of permanent injunction against Philips RS North America LLC (“Philips Respironics”), Respironics California LLC, and Philips Holding USA Inc., and Roy Jakobs, CEO of Royal Philips, along with several other individual defendants named in the decree. The consent decree, with limited exceptions, restrict ...
2y agoGFYFDA Roundup: April 9, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Friday, the FDA authorized for marketing MMI North America, Inc.’s Symani Surgical System, indicated for use during certain microsurgical procedures on small blood vessels and lymphatic ducts in adults. The system includes the use of a motion scaling function, which scales down the s ...
2y agoGFYFDA Roundup: April 5, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an emergency use authorization (EUA) for CorDx, Inc.’s CorDx TyFast Flu A/B & COVID-19 At Home Multiplex Rapid Test, a single use test intended to detect and differentiate influenza A and B (commonly known as flu) and SARS-CoV-2 (the virus that causes COVID-19), in ...
2y agoGFYFDA Approves New Antibiotic for Three Different UsesFDA Press ReleasesToday, the U.S. Food and Drug Administration approved Zevtera (ceftobiprole medocaril sodium for injection) for the treatment of adults with Staphylococcus aureus bloodstream infections (bacteremia) (SAB), including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections (ABSSSI); and adult and pediatric patients three months to less than 18 ye ...
2y agoGFYFDA Roundup: April 2, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA is releasing several scientific review policy memoranda that provide a snapshot of the FDA’s internal thinking on certain topics within the premarket tobacco review process. This action is consistent with commitments made by the FDA’s Center for Tobacco Products to post s ...
2y agoGFYFDA Roundup: March 29, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA made several updates to the Mammography Quality Standards Act and Program section on the FDA Website to enhance user experience and provide the most up-to-date information, including reordering and renaming the landing pages so the information is easier to find and ...
2y agoGFYFDA Roundup: March 26, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Thursday, the FDA made several updates to the Mammography Quality Standards Act and Program section on the FDA Website to enhance user experience and provide the most up-to-date information, including reordering and renaming the landing pages so the information is easier to find and ...
2y agoGFYFDA Warns Consumers to Avoid Certain Topical Pain Relief Products Due to Potential for Dangerous Health EffectsFDA Press ReleasesThe U.S. Food and Drug Administration is warning consumers not to use certain over-the-counter analgesic (pain relief) products that are marketed for topical use to relieve pain before, during or after certain cosmetic procedures, such as microdermabrasion, laser hair removal, tattooing and piercing. The agency issued warning letters to six companies for marketing these products in violation of fe ...
2y agoGFYFDA Roundup: March 26, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: On Monday, the FDA proposed a ban of electrical stimulation devices intended to reduce or stop self-injurious or aggressive behavior, a step rarely taken by the agency. The agency has determined that these devices present an unreasonable and substantial risk of illness or injury. This i ...
2y agoGFYFDA Roundup: March 22, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued an emergency use authorization for Pemgarda (pemivibart) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents (12 years of age and older weighing at least 40 kilograms [about 88 pounds]). Pemgarda is authorized for individuals ...
2y agoGFYFDA Approves Nonsteroidal Treatment for Duchenne Muscular DystrophyFDA Press ReleasesToday, the U.S. Food and Drug Administration approved Duvyzat (givinostat) oral medication for the treatment of Duchenne Muscular Dystrophy (DMD) in patients six years of age and older. Duvyzat is the first nonsteroidal drug approved to treat patients with all genetic variants of DMD. It is a histone deacetylase (HDAC) inhibitor that works by targeting pathogenic processes to reduce inflammation a ...
2y agoGFYFDA Roundup: March 19, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA provided an update on our evaluation of quality and performance issues related to plastic syringes made in China, and announced additional recommendations and actions the FDA is taking to address these issues. The FDA issued warning letters to three entities that describe ...
2y agoGFYFDA Approves First Gene Therapy for Children with Metachromatic LeukodystrophyFDA Press ReleasesToday, the U.S. Food and Drug Administration approved Lenmeldy (atidarsagene autotemcel), the first FDA-approved gene therapy indicated for the treatment of children with pre-symptomatic late infantile, pre-symptomatic early juvenile or early symptomatic early juvenile metachromatic leukodystrophy (MLD). Metachromatic leukodystrophy is a debilitating, rare genetic disease affecting the brain and n ...
2y agoGFYFDA Roundup: March 15, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA published its new paper, “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together,” which outlines specific focus areas regarding the development and use of AI across the medical product lifecycle. The paper helps further align and ...
2y agoMDGL GFYFDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver DiseaseFDA Press ReleasesToday, the U.S. Food and Drug Administration approved Rezdiffra (resmetirom) for the treatment of adults with noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), to be used along with diet and exercise. “Previously, patients with NASH who also have notable liver scarring did not have a medication that could directly address their liver damage,” sa ...
2y agoGFYFDA Roundup: March 12, 2024FDA Press ReleasesToday, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency: Today, the FDA issued the draft guidance Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the FD&C Act. This draft guidance proposes updated recommendations to industry on quality system considerations for cyber devices and for documentation in device premarket s ...