# drug administration (blogs) — RSS Amplifier Recent posts from the 3 feeds in the RSS Amplifier directory that cover drug administration. Page: Feed: --- ## [FDA Approves First Therapy for Patients aged 8 years and older with Glycogen Storage Disease Type Ia](http://www.fda.gov/news-events/press-announcements/fda-approves-first-therapy-patients-aged-8-years-and-older-glycogen-storage-disease-type-ia) _2026-08-19 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today issued an accelerated approval for Genglycos (pariglasgene brecaparvovec-opnr) as the first-ever treatment for adults and children 8 years of age and older with glycogen storage disease type Ia (GSDIa) ## [FDA Authorizes First-Of-Its-Kind Robotic Blood Draw Device](http://www.fda.gov/news-events/press-announcements/fda-authorizes-first-its-kind-robotic-blood-draw-device) _2026-08-19 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today authorized the Aletta, the first standalone robotic device that can draw blood from a patient’s arm without hands-on operator intervention. ## [FDA Seeks Public Feedback to Inform Regulatory Approach for Generative AI-Enabled Medical Devices](http://www.fda.gov/news-events/press-announcements/fda-seeks-public-feedback-inform-regulatory-approach-generative-ai-enabled-medical-devices) _2026-08-18 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today issued a discussion paper on considerations for the regulation of generative artificial intelligence (GenAI)-enabled medical devices, seeking feedback from interested parties on risk assessment, premarket evaluation, postmarket monitoring, and other topics ## [Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals](https://www.federalregister.gov/documents/2026/08/17/2026-16716/agency-information-collection-activities-announcement-of-office-of-management-and-budget-approvals) _2026-08-17 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. ## [Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements](https://www.federalregister.gov/documents/2026/08/17/2026-16715/agency-information-collection-activities-proposed-collection-comment-request-investigational-new) _2026-08-17 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. ## [Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI](https://www.federalregister.gov/documents/2026/08/17/2026-16713/determination-of-regulatory-review-period-for-purposes-of-patent-extension-bizengri) _2026-08-17 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIZENGRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human… ## [FDA Issues Emergency Use Authorization for Drug to Treat New World Screwworm in Dogs and Puppies](http://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-drug-treat-new-world-screwworm-dogs-and-puppies) _2026-08-13 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today issued an Emergency Use Authorization (EUA) for Simparica TRIO (sarolaner, moxidectin, and pyrantel chewable tablets) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs and puppies. ## [Substances Generally Recognized as Safe](https://www.federalregister.gov/documents/2026/08/11/2026-16296/substances-generally-recognized-as-safe) _2026-08-11 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act). ## [Determination of Regulatory Review Period for Purposes of Patent Extension; BRINSUPRI](https://www.federalregister.gov/documents/2026/08/10/2026-16247/determination-of-regulatory-review-period-for-purposes-of-patent-extension-brinsupri) _2026-08-10 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BRINSUPRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human… ## [Determination of Regulatory Review Period for Purposes of Patent Extension; DAYVIGO](https://www.federalregister.gov/documents/2026/08/10/2026-16246/determination-of-regulatory-review-period-for-purposes-of-patent-extension-dayvigo) _2026-08-10 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for DAYVIGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human… ## [Brisk AI News Briefings (Sponsored)](https://crawlproof.com/a/kg0oGBjFmugH) _2026-08-10 · **Sponsored**_ Read AI summaries and listen to audio briefings for top stories. ## [FDA Issues Emergency Use Authorization for Drug to Prevent New World Screwworm in Multiple Species, Including Sheep, Cattle, Goats, and Swine](http://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-drug-prevent-new-world-screwworm-multiple-species-including) _2026-08-07 · FDA · FDA Press Releases RSS Feed_ FDA today issued an Emergency Use Authorization (EUA) for CLiK Extra (dicyclanil topical suspension) wound spray for application on or around wounds for the prevention of New World screwworm (NWS) infestations (myiasis). ## [FDA Approves New Engineered Viral Immunotherapy for Patients with Treatment-Resistant Advanced Melanoma](http://www.fda.gov/news-events/press-announcements/fda-approves-new-engineered-viral-immunotherapy-patients-treatment-resistant-advanced-melanoma) _2026-08-06 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today granted accelerated approval to Tudriqev (vusolimogene oderparepvec-wtpg), a genetically modified oncolytic viral therapy for the treatment of advanced, refractory melanoma. ## [FDA Approves First Drug to Treat the Full Range of Narcolepsy Type 1 Symptoms](http://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-treat-full-range-narcolepsy-type-1-symptoms) _2026-08-05 · FDA · FDA Press Releases RSS Feed_ The FDA approved Orzeyful (oveporexton) tablets for the treatment of narcolepsy type 1 in adults. ## [Micro-Tracers, Inc.; Response to Objections and Requests for a Public Hearing](https://www.federalregister.gov/documents/2026/08/05/2026-15920/micro-tracers-inc-response-to-objections-and-requests-for-a-public-hearing) _2026-08-05 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA or we) received objections and requests for a public hearing submitted by Buchanan Ingersoll & Rooney PC, on behalf of Micro-Tracers, Inc. (Micro-Tracers or objector), on the order granting a color additive petition (3C0323) requesting that we repeal specified regulations to no longer provide for the safe use of FD&C Red No. 3 in food (including dietary… ## [Over-the-Counter Monograph Drug User Fee Rates for Fiscal Year 2027](https://www.federalregister.gov/documents/2026/07/30/2026-15344/over-the-counter-monograph-drug-user-fee-rates-for-fiscal-year-2027) _2026-07-30 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Over-the-Counter Monograph Drug User Fee Amendments (herein referred to as "OMUFA II"), authorizes the Food and Drug Administration (FDA, the Agency, or we) to assess and collect user fees from qualifying manufacturers of over-the-counter (OTC) monograph drugs and submitters of OTC monograph order requests (OMORs) for fiscal… ## [FDA Licenses First-Ever Freeze-Dried Plasma Product in the U.S.](http://www.fda.gov/news-events/press-announcements/fda-licenses-first-ever-freeze-dried-plasma-product-us) _2026-07-29 · FDA · FDA Press Releases RSS Feed_ FDA today licensed Ezplaz Freeze Dried Plasma (FDP), making it the first freeze-dried plasma product licensed for use in the United States. Ezplaz is intended for transfusion in adult patients who need plasma and for whom other plasma products are not available. ## [Medical Devices; Radiology Devices; Classification of the Phase-Changing Fiducial Marker for Radiation Therapy](https://www.federalregister.gov/documents/2026/07/29/2026-15303/medical-devices-radiology-devices-classification-of-the-phase-changing-fiducial-marker-for-radiation) _2026-07-29 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration (FDA) is classifying the phase-changing fiducial marker for radiation therapy into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the phase-changing fiducial marker for radiation therapy. We are taking this action because we have determined… ## [Statement of Organization, Functions, and Delegations of Authority](https://www.federalregister.gov/documents/2026/07/29/2026-15297/statement-of-organization-functions-and-delegations-of-authority) _2026-07-29 · Health and Human Services Department, Food and Drug Administration · Federal Register Documents matching 'animal testing', published on or after 07/21/2026, and from Food and Drug Administration_ The Food and Drug Administration's (FDA) plans to centralize and enhance key functions across the agency. These changes will reduce redundancies, improve efficiency, and advance alignment to better serve the American public. ## [FDA Announces First Participant Selected for TEMPO for Digital Health Devices Pilot](http://www.fda.gov/news-events/press-announcements/fda-announces-first-participant-selected-tempo-digital-health-devices-pilot) _2026-07-22 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today announced the first manufacturer selected for the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot. ## [FDA Takes Further Steps to Remove Outdated Authorizations for Color Additives in Food](http://www.fda.gov/news-events/press-announcements/fda-takes-further-steps-remove-outdated-authorizations-color-additives-food) _2026-07-22 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today announced two actions targeting petroleum-based color additives in food, continuing the agency’s broader efforts to Make America Healthy Again. ## [Retro Grid Dungeon Crawler (Sponsored)](https://crawlproof.com/a/0OpAeJlN1WRH) _2026-07-22 · **Sponsored**_ Retro grid movement with first-person combat, loot and skill-tree progression. ## [FDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol](http://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-pcsk9-inhibitor-lower-ldl-cholesterol-adults-high-cholesterol) _2026-07-17 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration approved Lipfendra (enlicitide), the first oral inhibitor of proprotein convertase subtilisin/kexin type 9 (PCSK9), as an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C), or “bad” cholesterol, in adults with hypercholesterolemi ## [FDA Issues Emergency Use Authorization for Drug for Short-Term Prevention of New World Screwworm in Horses](http://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-drug-short-term-prevention-new-world-screwworm-horses) _2026-07-15 · FDA · FDA Press Releases RSS Feed_ The FDA today issued an Emergency Use Authorization (EUA) for Ivermectin Liquid for Horses (ivermectin oral solution) for the short-term prevention of New World screwworm (NWS) infestations (myiasis) in horses when administered within 24 hours of birth or at the time of initial wound care. ## [FDA Proposes Rule to Modernize Drug Manufacturing Registration](http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-modernize-drug-manufacturing-registration) _2026-07-10 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a “hub-and-spoke” model. ## [FDA Approves First Gene Therapy for Young Children with Sickle Cell Disease](http://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-young-children-sickle-cell-disease) _2026-07-01 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today issued a supplemental approval for Casgevy (exagamglogene autotemcel) for patients aged 2 years and older with either sickle cell disease (SCD) with recurrent vaso-occlusive crises (VOCs) or transfusion-dependent β thalassemia (TDT). ## [FDA Approves New Treatment That Uses Donor Immune Cells to Prevent Serious Complications in Blood Cancer Patients](http://www.fda.gov/news-events/press-announcements/fda-approves-new-treatment-uses-donor-immune-cells-prevent-serious-complications-blood-cancer) _2026-06-30 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today approved TREGZI, the first regulatory T (Treg) cell-based immunotherapy for improving chronic graft-versus-host disease (GVHD)-free survival in adult patients with blood cancers undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT). ## [FDA Selects Seven Participants for PreCheck Pilot Program to Advance U.S. Drug Manufacturing](http://www.fda.gov/news-events/press-announcements/fda-selects-seven-participants-precheck-pilot-program-advance-us-drug-manufacturing) _2026-06-29 · FDA · FDA Press Releases RSS Feed_ FDA announces the selection of seven companies to participate in the FDA PreCheck Pilot Program, a new initiative designed to boost American global competitiveness, strengthen domestic drug manufacturing, and improve the resilience of the U.S. drug supply chain. ## [FDA Proposes Rule That Would Help Hold Foreign Tobacco Product Manufacturers Accountable, Protect Public Health](http://www.fda.gov/news-events/press-announcements/fda-proposes-rule-would-help-hold-foreign-tobacco-product-manufacturers-accountable-protect-public) _2026-06-26 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today issued a proposed rule that, if finalized, would help protect the public health of Americans, including youth, by strengthening the agency’s ability to efficiently identify illegal foreign tobacco products — including youth-appealing e-cigarettes — and con ## [FDA Approves First Single-Dose Generic Treatment for Influenza](http://www.fda.gov/news-events/press-announcements/fda-approves-first-single-dose-generic-treatment-influenza) _2026-06-17 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today approved the first generic of Xofluza (baloxavir marboxil) tablets, the first single-dose treatment for acute uncomplicated influenza and prophylaxis in patients 5 years of age and older. ## [FDA Broadens Access to Over-the-Counter Naloxone Nasal Spray for Opioid Overdose](http://www.fda.gov/news-events/press-announcements/fda-broadens-access-over-counter-naloxone-nasal-spray-opioid-overdose) _2026-06-16 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration (FDA) today approved another over-the-counter (OTC) intranasal naloxone product, Rextovy, a 4 milligram (mg) naloxone hydrochloride nasal spray for the emergency treatment of opioid overdose. ## [FDA Approves New Indication for Tzield (teplizumab) for Certain Pediatric Patients with Recently Diagnosed Stage 3 Type 1 Diabetes](http://www.fda.gov/news-events/press-announcements/fda-approves-new-indication-tzield-teplizumab-certain-pediatric-patients-recently-diagnosed-stage-3) _2026-06-15 · FDA · FDA Press Releases RSS Feed_ On June 12, 2026, the U.S. Food and Drug Administration granted accelerated approval to Tzield (teplizumab) for a new indication, to delay the decline of insulin production in pediatric patients ages 8 through 17 years who have been recently diagnosed with Stage 3 type 1 diabetes (T1D). ## [Home of the Agentic Pull Request (Sponsored)](https://crawlproof.com/a/xBMqosoXSQBy) _2026-06-15 · **Sponsored**_ CLI-first, TUI-ready toolkits and a moshscript installer — join the waitlist ## [FDA Clears First Over-the-Counter Continuous Glucose Monitor for Children](http://www.fda.gov/news-events/press-announcements/fda-clears-first-over-counter-continuous-glucose-monitor-children) _2026-06-12 · FDA · FDA Press Releases RSS Feed_ The U.S. Food and Drug Administration today cleared for marketing the first over-the-counter (OTC) continuous glucose monitor (CGM) for children, Dexcom Inc.’s Stelo Glucose Biosensor System, an integrated CGM (iCGM) indicated for people two years of age and older who do not use insulin. ## [FDA Issues Emergency Use Authorization for Generic Over-the-Counter Drug to Treat New World Screwworm in Dogs and Cats](http://www.fda.gov/news-events/press-announcements/fda-issues-emergency-use-authorization-generic-over-counter-drug-treat-new-world-screwworm-dogs-and) _2026-06-11 · FDA · FDA Press Releases RSS Feed_ FDA today issued an Emergency Use Authorization (EUA) for generic Nitenpyram Tablets (nitenpyram) for the treatment of New World screwworm (NWS) infestations (myiasis) in dogs, puppies, cats, and kittens that weigh at least two pounds and are at least four weeks old. ## [FDA Expands Sunscreen Options for the First Time in 20 Years](http://www.fda.gov/news-events/press-announcements/fda-expands-sunscreen-options-first-time-20-years) _2026-06-09 · FDA · FDA Press Releases RSS Feed_ Today, the U.S. Food and Drug Administration added bemotrizinol to the list of permitted sunscreen active ingredients, marking a significant milestone in the agency's efforts to advance sunscreen innovation. ## [Umary contains hidden drug ingredients](http://www.fda.gov/drugs/medication-health-fraud-notifications/umary-contains-hidden-drug-ingredients) _2026-04-07 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use Umary, a product promoted and sold for pain on various websites, including https://www.solovital.com and possibly in some retail stores. ## [BIG GUYS Male Energy Supplement contains hidden drug ingredient](http://www.fda.gov/drugs/medication-health-fraud/big-guys-male-energy-supplement-contains-hidden-drug-ingredient) _2025-07-24 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use BIG GUYS Male Energy Supplement, a product promoted and sold as an energy booster on the website www.amazon.com and possibly in some retail stores. ## [The Rock contains hidden drug ingredient](http://www.fda.gov/drugs/medication-health-fraud/rock-contains-hidden-drug-ingredient) _2025-07-24 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use The Rock, a product promoted and sold for sexual enhancement on various websites, and possibly in some retail stores. This product was distributed by Noah’s Wholesale, LLC. ## [Ram It contains hidden drug ingredient](http://www.fda.gov/drugs/medication-health-fraud/ram-it-contains-hidden-drug-ingredient) _2025-07-24 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use Ram It, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores. ## [T XTRA Strength Test Booster contains hidden drug ingredient](http://www.fda.gov/drugs/medication-health-fraud/t-xtra-strength-test-booster-contains-hidden-drug-ingredient) _2025-07-24 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use T XTRA Strength Test Booster, a product promoted and sold for sexual enhancement and as an energy booster on various websites, including www.amazon.com, and possibly in some retail stores. ## [TO THE MOON contains hidden drug ingredient](http://www.fda.gov/drugs/medication-health-fraud/moon-contains-hidden-drug-ingredient) _2025-07-24 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use TO THE MOON, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores. ## [Wild Bull contains hidden drug ingredient](http://www.fda.gov/drugs/medication-health-fraud/wild-bull-contains-hidden-drug-ingredient) _2025-07-24 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use Wild Bull, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores. ## [ForeverMen contains hidden drug ingredient](http://www.fda.gov/drugs/medication-health-fraud/forevermen-contains-hidden-drug-ingredient) _2025-07-24 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use ForeverMen, a product promoted and sold as an energy booster on various websites, including www.amazon.com, and possibly in some retail stores. FDA laboratory analysis confirmed that ForeverMen contains sildenafil, the ## [ENDUREA contains hidden drug ingredients](http://www.fda.gov/drugs/medication-health-fraud/endurea-contains-hidden-drug-ingredients) _2025-07-24 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use ENDUREA, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores. ## [Sustain® contains hidden drug ingredients](http://www.fda.gov/drugs/medication-health-fraud/sustainr-contains-hidden-drug-ingredients) _2025-07-24 · FDA · Health Fraud RSS Feed_ The Food and Drug Administration is advising consumers not to purchase or use Sustain®, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores.