medscopeglobal.com · FDA · Novinky
Novinky k humánním lékům
Aktuální sdělení FDA k humánním léčivým přípravkům a regulaci v USA.
FDA approves lutetium Lu 177 vipivotide tetraxetan with androgen receptor pathway inhibitor therapy for metastatic androgen pathway modulation-naïve or -sensitive prostate cancer
FDA · 31. 7. 2026
On July 31, 2026, the Food and Drug Administration approved lutetium Lu 177 vipivotide tetraxetan (Pluvicto, Novartis Pharmaceuticals Corporation) in combination with androgen receptor pathway inhibitor (ARPI) therapy for adults with prostate-specific membrane antigen (PSMA)-positive metastatic andr
NovinkaNubratori, Inc. dba Nubratori Rx - 700513 - 07/27/2026
FDA · 30. 7. 2026
Compounding Pharmacy/Adulterated Drug Products Zdroj: FDA
NovinkaDuPont Nutrition USA Inc. - 627211 - 07/22/2026
FDA · 30. 7. 2026
CGMP/Drug Products/Adulterated Zdroj: FDA
NovinkaNubratori, Inc. dba Nubratori Rx - 700513 - 01/22/2025
FDA · 30. 7. 2026
Compounding Pharmacy/Adulterated Drug Products <br> Zdroj: FDA
SchválenoSimilasan AG - 658878 - 09/11/2023
FDA · 30. 7. 2026
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug Zdroj: FDA
SchválenoSimilasan AG - 658878 - 07/29/2026
FDA · 30. 7. 2026
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug Zdroj: FDA
NovinkaMedisourceRx - 717970 - 07/27/2026
FDA · MedisourceRx · 30. 7. 2026
Compounding Pharmacy/Adulterated Drug Products Zdroj: FDA
NovinkaDuPont Nutrition USA Inc. - 627211 - 12/02/2022
FDA · 30. 7. 2026
CGMP/Drug Products/Adulterated<br> Zdroj: FDA
NovinkaMedisourceRx - 717970 - 12/12/2025
FDA · MedisourceRx · 30. 7. 2026
Compounding Pharmacy/Adulterated Drug Products Zdroj: FDA
NovinkaDrug Trials Snapshots: DECNUPAZ
FDA · 29. 7. 2026
Drug Trials Snapshots: DECNUPAZ Zdroj: FDA
NovinkaUpcoming Product-Specific Guidances for Generic Drug Product Development
FDA · 28. 7. 2026
Information related to upcoming new and revised product-specific guidances (PSGs) to support the development and approval of safe and effective complex generic drug products. Zdroj: FDA
NovinkaNew Approach Methodologies (NAMs)
FDA · 28. 7. 2026
The FDA is leading a transformative shift in drug safety evaluation—reducing, replacing or refining animal testing with advanced, human-relevant methods that better predict how medicines work in people. Zdroj: FDA
NovinkaFDA Issues Warning Letter to AHC Products, Inc.
FDA · 28. 7. 2026
The U.S. Food and Drug Administration (FDA) issued a warning letter to AHC Products, Inc. regarding violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. The products were found to be adulterated.
PipelineExpedited IND Pilot Program Educational Webinar for Stakeholders - 08/06/2026
FDA · 27. 7. 2026
An educational webinar on a proposal to establish the Expedited Investigational New Drug (IND) pilot program, a new program meant to accelerate the time from drug identification to first-in-human (FIH) clinical trial. Zdroj: FDA
NovinkaCDER Patient-Focused Drug Development
FDA · 27. 7. 2026
Patient-focused drug development (PFDD) is a systematic approach to help ensure that patients’ experiences, perspectives, needs, and priorities are captured and meaningfully incorporated into drug development and evaluation. The primary goal of patient-focused drug development is to better incorpora Zdroj: FDA
SchválenoElectronic Registration and Listing Compliance Program
FDA · 27. 7. 2026
Establishment registration and drug listing data is submitted by drug manufacturers and own label drug distributors through electronic means using Structured Product Labeling format (SPL). Zdroj: FDA
SchválenoFDA approves zidesamtinib for ROS1-positive non-small cell lung cancer
FDA · 24. 7. 2026
On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI). Zdroj: FDA
NovinkaBAXTER ISSUES VOLUNTARY NATIONWIDE RECALL OF CEFAZOLIN IN DEXTROSE INJECTION, USP, 2G / 100ML (20MG / ML) SINGLE-DOSE INFUSION BAG IN 100ML DUE TO PARTICULATE MATTER FOUND IN SOLUTION
FDA · 24. 7. 2026
July 24, 2026 – DEERFIELD, Ill., Baxter International Inc. (NYSE:BAX) is voluntarily recalling Lot LD175708, Exp 14-Feb 2027 of Cefazolin in Dextrose Injection due to a report of particulate matter found in the solution identified as cardboard. Risk Statement: The use of the defective product has a Zdroj: FDA
NovinkaReviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
FDA · 23. 7. 2026
The following are the medical, statistical, and clinical pharmacology reviews of pediatric studies conducted in response to a Written Request issued under the BPCA and pediatric assessments conducted under PREA.
NovinkaKangaroo Intense Venus 3000 may be harmful due to hidden drug ingredient
FDA · 23. 7. 2026
The Food and Drug Administration is advising consumers not to purchase or use Kangaroo Intense Venus 3000, a product promoted for sexual enhancement on various websites, including https://usroyalhoney.com, and possibly in some retail stores.
NovinkaPurushothaman Damodara Kumaran, M.D. / Senthil Specialty Hospital - 721325 - 12/22/2025
FDA · 22. 7. 2026
In Vivo Bioavailability-Bioequivalence Studies – Clinical Zdroj: FDA
SchválenoWarning Letter Issued to NSE Products, Inc. DBA Nu Skin Enterprises, Inc.
FDA · 21. 7. 2026
The FDA issued a warning letter to NSE Products, Inc. DBA Nu Skin Enterprises, Inc. regarding violations related to the Electronic Drug Registration and Listing System (eDRLS).
PipelineFDA Virtual Workshop on Digital Health Technologies and Statistical Considerations for Digitally-Derived Endpoints in Clinical Trials
FDA · 21. 7. 2026
On Thursday, August 27, 2026, the FDA is hosting a free virtual public workshop, convened by the Duke-Margolis Institute for Health Policy under a cooperative agreement with the FDA, to discuss statistical considerations for digitally-derived endpoints in clinical trials for drug and biological products.
NovinkaCentaur Pharmaceuticals Private Ltd. Receives Warning Letter from FDA
FDA · 21. 7. 2026
The FDA issued a warning letter to Centaur Pharmaceuticals Private Ltd. regarding violations of Current Good Manufacturing Practices (CGMP) related to Active Pharmaceutical Ingredient (API) production, resulting in adulterated products.
SchválenoWarning Letter Issued to NSE Products, Inc. DBA Nu Skin Enterprises, Inc.
FDA · 21. 7. 2026
The FDA issued a warning letter to NSE Products, Inc. DBA Nu Skin Enterprises, Inc. regarding violations related to the Electronic Drug Registration and Listing System (eDRLS).
NovinkaFDA Rare Disease Innovation Hub
FDA · 21. 7. 2026
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
SchválenoWritten Requests Issued
FDA · 20. 7. 2026
Updated list of approved active moieties to which FDA has issued a Written Request for pediatric studies.
NovinkaAdvancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs
FDA · 20. 7. 2026
This half-day workshop includes a series of expert-lead presentations and audience Q&A sessions focused on the latest advancements and regulatory considerations in the evolving field of Model-Integrated Evidence (MIE)-supported generic drug development and approval.
NovinkaUnique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) Issues Voluntary Nationwide Recall of Cetirizine Hydrochloride Tablets USP 5 mg Due to Potential Cross Contamination with Ranitidine
FDA · 20. 7. 2026
FOR IMMEDIATE RELEASE – July 18th, 2026 – Panoli, Gujarat, Unique Pharmaceutical Laboratories (A Div. of J. B. Chemicals & Pharmaceuticals Ltd.) is voluntarily recalling four lots of Cetirizine Hydrochloride Tablets USP 5 mg to the consumer level due to cross contamination with Ranitidine. Zdroj: FDA
NovinkaDrugs@FDA Data Files
FDA · 17. 7. 2026
Drugs@FDA Downloadable Data File in ZIP format, Data Definitions, and Entity Relationship Diagram (ERD) Zdroj: FDA
NovinkaInnovative Science and Technology Approaches for New Drugs (ISTAND) Program Submission Process
FDA · 17. 7. 2026
The 21st Century Cures Act formally established a multi-step process for Drug Development Tools (DDT) qualification. Qualification of a DDT is for a specific context of use (COU), and the qualified DDT may be used for the COU by any person in drug or biologics development. Zdroj: FDA
SchválenoFDA Approves First Oral PCSK9 Inhibitor to Lower LDL Cholesterol in Adults with High Cholesterol
FDA · 17. 7. 2026
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 Zdroj: FDA
NovinkaInternet Pharmacy Warning Letters
FDA · 17. 7. 2026
Rogue online pharmacies offer potentially dangerous prescription drugs to U.S. consumers. FDA has issued warning letters informing the website operators that they are engaged in illegal activity in violation of the U.S. Federal Food, Drug, and Cosmetic Act Zdroj: FDA
SchválenoFDA Issues Warning Letter to Wholesale Peptide
FDA · 16. 7. 2026
The FDA has issued a warning letter to Wholesale Peptide regarding unapproved new drugs and misbranding. The letter, dated 06/17/2026, outlines the violations found.
SchválenoFDA Issues Warning Letter to MantroForce
FDA · MantroForce · 16. 7. 2026
The FDA has issued a warning letter to MantroForce regarding unapproved new drugs and misbranding. The letter, dated June 17, 2026, details the violations found.
SchválenoPediatric Exclusivity Granted
FDA · 16. 7. 2026
Approved active drugs with sponsors to which FDA has granted exclusivity for pediatric studies under Section 505A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Zdroj: FDA
NovinkaDrug Shortages
FDA · 15. 7. 2026
Aktualizace z oficiálního zdroje FDA. MedScopeGlobal přináší strukturovaný přehled pro českou odbornou praxi s odkazem na primární dokument.
NovinkaFDA/Duke-Margolis Institute for Health Policy Virtual Public Meeting: Innovation in Quantitative Medicine Summit - 09/01/2026
FDA · 15. 7. 2026
The Duke-Margolis Institute for Health Policy and the U.S. Food and Drug Administration's (FDA) Quantitative Medicine Center of Excellence (QM CoE) will co-convene a virtual workshop to inform the establishment of the Quantitative Medicine Innovation Network (QMIN). Zdroj: FDA
NovinkaCDER Leadership Bios
FDA · 15. 7. 2026
Aktualizace z oficiálního zdroje FDA. MedScopeGlobal přináší strukturovaný přehled pro českou odbornou praxi s odkazem na primární dokument.
NovinkaSafe Drug Use After a Natural Disaster
FDA · 15. 7. 2026
Information on the use of medicines that may be affected by fire, flooding or unsafe water, and on the use of temperature-sensitive drugs when refrigeration is temporarily unavailable. Zdroj: FDA
SchválenoNatural Disaster Preparedness and Response | Drugs
FDA · 15. 7. 2026
Stay informed on FDA's guidance for drugs used in natural disaster preparedness and response. Learn about emergency drug supplies, FDA-approved treatments, and safety measures for public health during disasters like hurricanes, floods, and more. Zdroj: FDA
NovinkaTawon Liar contains hidden drug ingredient
FDA · 14. 7. 2026
FDA is advising consumers not to purchase or use Tawon Liar, a product promoted and sold for pain, rheumatism, insomnia, improving the immune system, increasing energy, and lowering cholesterol on various websites, including www.etsy.com, and possibly in some retail stor Zdroj: FDA
NovinkaRare Disease News, Events & Reports
FDA · 14. 7. 2026
Learn more about recent news and events related to rare diseases and read ARC Program Annual Reports. Zdroj: FDA
NovinkaXian Ling may be harmful due to hidden drug ingredients
FDA · 14. 7. 2026
The Food and Drug Administration is advising consumers not to purchase or use Xian Ling, a product promoted and sold for pain on various websites and in some retail stores. Zdroj: FDA
NovinkaPain and Arthritis Products Containing Hidden Ingredients
FDA · 14. 7. 2026
Learn about the warnings for pain and arthritis products that contain hidden drugs and other hidden ingredients. Zdroj: FDA
NovinkaRare Disease Drug Approvals
FDA · 14. 7. 2026
This page describes recent rare disease drug approvals that received a CDER or FDA communication. This is not an exhaustive list of all rare disease drug approvals. Zdroj: FDA
NovinkaMOU 225-26-007
FDA · 13. 7. 2026
This Memorandum of Understanding ("MOU") between the U.S. Department of Health and Human Services (HHS), the U.S. Food and Drug Administration (FDA), and the U.S. Department of Veterans Affairs (VA) (hereafter “the Parties” or “Federal Partners”) provides a framework for collaboration and the exchan Zdroj: FDA
PipelinePhase 1 IND Guidance Documents
FDA · 13. 7. 2026
Find FDA Guidance Documents related to Phase 1 IND submissions Zdroj: FDA
NovinkaNotifications on Data Integrity
FDA · 13. 7. 2026
FDA notifications for industry on data integrity. Zdroj: FDA
NovinkaCDER Small Business & Industry Assistance (SBIA)
FDA · 13. 7. 2026
A Comprehensive Resource for Information on Human Drug Development in Regulation Zdroj: FDA
NovinkaPsychedelic Drugs
FDA · 13. 7. 2026
FDA is supporting the development of psychedelic drugs, including new treatments for serious mental health conditions. Zdroj: FDA
NovinkaHiding in Plain Sight: 7-OH Products
FDA · 13. 7. 2026
The FDA is addressing the emergence of 7-OH products, which represent a potential fourth opioid epidemic. This highlights a public health concern related to these substances.
NovinkaANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions
FDA · 10. 7. 2026
ANDAs: Pre-Submission Facility Correspondence Related to Prioritized Generic Drug Submissions Zdroj: FDA
NovinkaCDER proposes to withdraw approval of TAVNEOS
FDA · 10. 7. 2026
The Center for Drug Evaluation and Research (CDER) is proposing to withdraw the approval of TAVNEOS (avacopan) for the treatment of severe active ANCA-associated vasculitis. The proposal is based on new data that suggests the drug may not be as effective as previously thought.
PipelineC3TI Compass (Knowledge Repository)
FDA · 9. 7. 2026
Centralized knowledge repository for clinical trial innovation Zdroj: FDA
NovinkaThe FDA at 120: A Long, Distinguished History Protecting Americans
FDA · 9. 7. 2026
Since 1906 Americans have relied on, and benefited from, the FDA’s oversight of our food, medical products, veterinary products, cosmetics, and so much more. Zdroj: FDA
NovinkaPatient Listening Session Summaries
FDA · 9. 7. 2026
Patient Listening Session summaries are published after each session to share a high-level summary of the discussion. The Public Engagement Staff draft summaries for FDA-requested sessions and the patient community requester drafts summaries for Patient-led sessions. Zdroj: FDA
NovinkaFDA Actions to Support and Strengthen Domestic Drug Manufacturing
FDA · 9. 7. 2026
The FDA is taking decisive steps to strengthen U.S. pharmaceutical manufacturing, improve supply chain resilience, and ensure Americans have reliable access to safe, effective, high-quality medicines. Zdroj: FDA
NovinkaeCTD Submission Standards for eCTD v3.2.2 and Regional M1
FDA · 9. 7. 2026
Aktualizace z oficiálního zdroje FDA. MedScopeGlobal přináší strukturovaný přehled pro českou odbornou praxi s odkazem na primární dokument.
NovinkaeCTD Submission Standards for eCTD v4.0 and Regional M1
FDA · 9. 7. 2026
A listing of the Implementation Guides, Specifications, and Documentation that support the FDA implementation for eCTD v4.0 Zdroj: FDA
NovinkaDrug Trials Snapshots: VOYXACT
FDA · 8. 7. 2026
Drug Trials Snapshots: VOYXACT Zdroj: FDA
NovinkaNational Drug Code Format
FDA · 8. 7. 2026
FDA’s final rule, Revising the National Drug Code Format and Drug Label Barcode Requirements, adopts a uniform, 12-digit format for the national drug code (NDC). Zdroj: FDA
NovinkaNovel Drug Approvals for 2025
FDA · 8. 7. 2026
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. Zdroj: FDA
NovinkaDrug Trials Snapshots
FDA · 8. 7. 2026
Drug Trials Snapshots: breaking down the what, how and why. Drug Trials Snapshots are part of an overall FDA effort to make demographic data more available and transparent. Zdroj: FDA
NovinkaOver-The-Counter Monograph Drug User Fee Program (OMUFA)
FDA · Over-The · 7. 7. 2026
A user fee program for nonprescription (over-the-counter or OTC) monograph drugs would be a potential funding mechanism to supplement congressional non user-fee appropriations. Zdroj: FDA
NovinkaMedical Products for Rare Diseases and Conditions
FDA · 7. 7. 2026
The Orphan Drug Designation program provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons Zdroj: FDA
NovinkaGuidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations
FDA · 7. 7. 2026
Guidance Recap Podcast | Assessing the Effects of Food on Drugs in INDs and NDAs – Clinical Pharmacology Considerations Zdroj: FDA
NovinkaGuidance Snapshot Pilot
FDA · 7. 7. 2026
Guidance Snapshots are a communication tool that provide highlights from the document using visuals and plain language. This pilot program is intended to increase awareness for FDA guidance documents to support the efficient application of the documents’ recommendations. Zdroj: FDA
NovinkaNovel Drug Approvals for 2026
FDA · 7. 7. 2026
This page lists novel drug approvals by the FDA for the year 2026. It serves as a central resource for tracking new therapeutic advancements authorized by the agency.
SchválenoFDA Approves First Treatment for COVID-19
FDA · 6. 7. 2026
FDA approved the antiviral drug Veklury (remdesivir) for adults and pediatric patients 12 years of age and older for the treatment of COVID-19 requiring hospitalization. Veklury is the first treatment for COVID-19 to receive FDA approval. Zdroj: FDA
NovinkaCoronavirus (COVID-19) Update: FDA Authorizes Drug Combination for Treatment of COVID-19
FDA · 6. 7. 2026
Today, the FDA issued an emergency use authorization for the drug baricitinib, in combination with remdesivir, for the treatment of COVID-19 in hospitalized adults and pediatric patients 2+ years requiring supplemental oxygen, invasive mechanical ventilation, or ECMO. Zdroj: FDA
NovinkaCoronavirus (COVID-19) | Drugs
FDA · 6. 7. 2026
CDER is engaged in numerous activities to protect and promote public health during the COVID-19 pandemic. Zdroj: FDA
NovinkaCoronavirus (COVID-19) Update: FDA Warns of Newly Discovered Potential Drug Interaction That May Reduce Effectiveness of a COVID-19 Treatment Authorized for Emergency Use
FDA · 6. 7. 2026
FDA is warning about a potential drug interaction with remdesivir, which received emergency use authorization to treat hospitalized COVID-19 patients with severe disease. Zdroj: FDA
NovinkaCOVID-19 Update: FDA’s Ongoing Commitment to Transparency for COVID-19 EUAs
FDA · COVID · 6. 7. 2026
FDA is committed to transparency around the EUA process Zdroj: FDA
NovinkaInnovation to Respond to COVID-19
FDA · 6. 7. 2026
Learn about FDA’s innovative approaches to respond to COVID-19 as quickly and safely as possible. Zdroj: FDA
SchválenoLyfeUnit / www.lyfeunit.com - 725156 - 06/23/2026
FDA · 5. 7. 2026
FDA issued a warning letter to LyfeUnit regarding Unapproved New Drugs/Misbranded products sold on www.lyfeunit.com.
NovinkaDrug Alerts and Statements
FDA · 2. 7. 2026
See updates from CDER on fast-moving issues and learn about CDER's work to enhance public health Zdroj: FDA
NovinkaFDA Listing of Authorized Generics
FDA · 2. 7. 2026
FDA Listing of Authorized Generics Zdroj: FDA
NovinkaFDA Alerts Health Care Providers to Cases of Neurologic Complications from General Anesthesia Linked to Genetic Variant in Patients of Maternal Venezuelan Ancestry
FDA · 2. 7. 2026
The U.S. Food and Drug Administration (FDA) is investigating the safety of sevoflurane and other general anesthetics based on published scientific reports of unexpected catastrophic outcomes, including severe neurologic adverse outcomes and death, occurring in adult and pediatric patients. Zdroj: FDA
NovinkaRegistered Outsourcing Facilities
FDA · 23. 6. 2026
Discover FDA's comprehensive list of registered outsourcing facilities engaged in human drug compounding. Get the latest updates, compliance guidelines, and resources to ensure safe, high-quality compounded medications. Explore regulations and stay informed with verified facility details. Zdroj: FDA
NovinkaGuidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
FDA · 23. 6. 2026
Guidance Recap Podcast | Digital Health Technologies for Remote Data Acquisition in Clinical Investigations Zdroj: FDA
NovinkaIND Application Reporting: IND Safety Reports
FDA · 23. 6. 2026
This webpage provides an overview of investigational new drug application (IND) safety reporting requirements for sponsors set forth in 21 CFR 312.32 and additional resources, including FDA guidances, related to these requirements. Zdroj: FDA
NovinkaCDER Small Business and Industry Assistance (SBIA) Learn
FDA · 23. 6. 2026
SBIA Learn offers a variety of multimedia resources to provide information that is comprehensive, interactive, and easily accessible to small pharmaceutical business and industry. Zdroj: FDA
NovinkaRecently Issued Guidance Documents
FDA · 23. 6. 2026
This page lists Recently Issued CBER and Cross-Center Guidance Documents. Zdroj: FDA
NovinkaFDA Actions to Accelerate and Modernize Early and Late-Stage Clinical Development
FDA · 22. 6. 2026
Learn more about actions to accelerate and modernize clinical research across the full continuum of drug development —from the Investigational New Drug (IND) phase to late-stage pivotal trials. Zdroj: FDA
PipelineOngoing | Cancer Accelerated Approvals
FDA · 22. 6. 2026
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have postmarketing requirement(s) for ongoing clinical trial(s) to verify clinical benefit. Zdroj: FDA
NovinkaDigital Health Technologies (DHTs) for Drug Development
FDA · 22. 6. 2026
Digital Health Technologies (DHTs) for Drug Development Zdroj: FDA
NovinkaGeneric Drugs Program Monthly and Quarterly Activities Report
FDA · 22. 6. 2026
Monthly and quarterly metrics of the FDA Generic Drugs Program. Zdroj: FDA
NovinkaGuidance Recap Podcast | Master Protocols for Drug and Biological Product Development
FDA · 22. 6. 2026
Guidance Recap Podcast | Master Protocols for Drug and Biological Product Development Zdroj: FDA
SchválenoWithdrawn | Cancer Accelerated Approvals
FDA · 22. 6. 2026
This listing includes accelerated approvals (AAs) for malignant hematology and oncology indications that have been subsequently withdrawn, and are therefore, no longer FDA-approved. Zdroj: FDA
NovinkaUntitled Letters
FDA · 18. 6. 2026
These letters are supplied by the CDER Freedom of Information Office and only cover Office of Prescription Drug Promotion's untitled letters.
NovinkaCommissioner's National Priority Voucher (CNPV) Pilot Program
FDA · 18. 6. 2026
FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.
NovinkaPatent Certifications and Suitability Petitions
FDA · 18. 6. 2026
Information on patents and suitability petitions that impact the availability of generic drugs.
NovinkaGeneric Drug Facilities, Sites and Organization Lists
FDA · 17. 6. 2026
Generic Drug Facilities, Sites and Organization Lists Zdroj: FDA
NovinkaBsUFA IV: Fiscal Years 2028-2032
FDA · 17. 6. 2026
On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022.
NovinkaInvestigational New Drug (IND) Application
FDA · 17. 6. 2026
Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.
NovinkaVědecké partnerství veřejného a soukromého sektoru
FDA · 17. 6. 2026
Find out how CDER works with partners and consortia to identify science gaps in drug development
SchválenoFDA Approves First Single-Dose Generic Treatment for Influenza
FDA · 17. 6. 2026
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.
NovinkaCompounding Quality Center of Excellence | Instructor-Led Trainings
FDA · 15. 6. 2026
The Compounding Quality Center of Excellence’s free in-person training programs target outsourcing facility staff and offer continuing education credits. The training will open for state regulators and pharmacy compounders if space is available.
SchválenoDevelopment of Antihypertensive Therapies for Use in Pediatric Patients
FDA · 15. 6. 2026
Treatment of chronic hypertension (high blood pressure) in pediatric patients remains an area of unmet medical need, with limited FDA-approved therapies, particularly for children younger than six years of age. Products are being developed to treat uncontrolled and/or resistant hypertension in adults that may have benefits in pediatric patients.
NovinkaBeekeeper’s Naturals Issues Voluntary Nationwide Recall of Beekeeper’s Naturals Saline Nasal Spray Sold Through Amazon Due to Microbial Contamination
FDA · 15. 6. 2026
FOR IMMEDIATE RELEASE – June 11, 2026, Covina, CA - Beekeeper’s Naturals is voluntarily recalling lot # 5950, Exp. Date 02/2028 of Beekeeper’s Naturals Saline Nasal Spray, sold only through Amazon, to the consumer level.
NovinkaHuman Drug Imports
FDA · 15. 6. 2026
Human drug import information including PLAIR, safe importation action plan, and personal importation policy.
NovinkaFrequently Asked Questions About Drugs
FDA · 15. 6. 2026
Frequently Asked Questions About Drugs<br>
NovinkaCompounding Quality Center of Excellence | Self-Guided Online Trainings
FDA · 15. 6. 2026
FDA Compounding Quality Center of Excellence’s is providing anytime, anywhere training resources to support outsourcing facilities and other stakeholders in their efforts to enhance the quality of compounded drugs.
NovinkaGeneric Drug User Fee Amendments
FDA · 13. 6. 2026
This page features news and information for industry and stakeholders about GDUFA, its fee structure, payment methods, and related information.
NovinkaOncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA · 12. 6. 2026
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
NovinkaStudy Data Technical Conformance Guide
FDA · 12. 6. 2026
This technical specifications document represents the Food and Drug Administration's (FDA's) current thinking on this topic.
SchválenoFDA Approves Drug for Pediatric Stage 3 Type I Diabetes
FDA · 12. 6. 2026
The U.S. Food and Drug Administration (FDA) has approved Tzield (teplizumab) injection to delay (slow down) the loss of the body’s own insulin production for pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 Type I diabetes (T1D).
NovinkaSchválení nového léku
FDA · 12. 6. 2026
Aktualizace z oficiálního zdroje FDA. MedScopeGlobal přináší strukturovaný přehled pro českou odbornou praxi s odkazem na primární dokument.
NovinkaClinicalTrials.gov: Essentials for Academic Medical Centers
FDA · 11. 6. 2026
This virtual training is designed to help staff at academic medical centers meet the federal requirements for registering clinical studies and reporting results on ClinicalTrials.gov.
SchválenoNový lék schválen FDA
FDA · Lék X · 11. 6. 2026
FDA schválila nový lék pro léčbu pacientů s vzácnou nemocí
PipelineNovinky z FDA
FDA · 11. 6. 2026
Denní přehled registrací a aktualit z agentury FDA
NovinkaBusiness Pill may be harmful due to hidden drug ingredient
FDA · 10. 6. 2026
The FDA is warning consumers not to use Business Pill due to a hidden drug ingredient
NovinkaBranch Manager for Men may be harmful due to hidden drug ingredient
FDA · 10. 6. 2026
The FDA is advising consumers not to purchase or use Branch Manager for Men due to a hidden drug ingredient
SchválenoFDA notification regarding unapproved drugs included in kits
FDA · 10. 6. 2026
FDA requested Azurity Pharmaceuticals Inc. to stop distributing unapproved drugs marketed as Unit-of-Use Prescription Compounding Kits
PipelineNovinky z FDA
FDA · Neuvedeno · 10. 6. 2026
Denní přehled registrací léků u FDA
NovinkaNovinky ze světa léků
FDA · 10. 6. 2026
Stránka FDA poskytuje rychlé odkazy na nejnovější informace o různých tématech, včetně schválení léků, bezpečnostních varování a nedostatku léků.
NovinkaNew Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
FDA · 10. 6. 2026
FDA's Adverse Event Monitoring System (AEMS) identifies potential signals of serious risks and new safety information for drugs
NovinkaVarování před produkty pro sexuální výkon a energii
FDA · 10. 6. 2026
FDA vydala varování před produkty pro sexuální výkon a energii, které obsahují skryté léky a další skryté složky.
SchválenoNový lék schválen FDA
FDA · Lék X · 8. 6. 2026
FDA schválila nový lék pro léčbu pacientů s vzácným onemocněním.
SchválenoSchválili nový lék
FDA · Léčivo X · 7. 6. 2026
FDA schválila nový lék pro léčbu závažných onemocnění
SchválenoNový lék schválen FDA
FDA · Lék X · 6. 6. 2026
FDA schválila nový lék pro léčbu závažných onemocnění
PipelineNovinky z FDA
FDA · Neuvedeno · 5. 6. 2026
Denní přehled registrací a aktualit z FDA
SchválenoNový lék schválen FDA
FDA · Lék X · 4. 6. 2026
FDA schválila nový lék, který má pomoci pacientům s vážnými zdravotními problémy.
NovinkaFDA — denní přehled registrací
FDA · 3. 6. 2026
Automatický monitoring https://www.fda.gov/
Agregovaný přehled MedScopeGlobal · oficiální zdroje: SÚKL · SÚKL · EMA · EMA · FDA. U každé položky odkaz na primární dokument.