Influenza Virus Vaccine, H5N1 (for National Stockpile)
List of Injectable Vaccines - Influenza Virus Vaccine, H5N1 (for National Stockpile)
October 4, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies - 11/12/2024
Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies
Marcus Research Laboratory, Inc. - 615153 - 10/02/2024
CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
FDA approves neoadjuvant/adjuvant nivolumab for resectable non-small cell lung cancer
On October 3, 2024, the FDA approved neoadjuvant/adjuvant nivolumab with platinum-doublet chemotherapy for resectable non-small cell lung cancer.
April - June 2024 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
Explore potential signals of serious risks and new safety information identified by the FDA from April to June 2024 via the Adverse Event Reporting System (FAERS). Stay informed on emerging drug safet
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss
FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.
Compounding when Drugs are on FDA’s Drug Shortages List
FDA understands that when a drug is in shortage, patients and health care professionals may look to compounded drugs as an option to get the medication they need.
Public Notification: Body Shape Weight Loss System contains hidden drug ingredients
The Food and Drug Administration is advising consumers not to purchase or use Body Shape Weight Loss System, a product promoted for weight loss. This product was identified during an examination of imported goods.
BSO LLC. Lakewood, CO. 483 issued 07/03/2024
Task Description Request Please post to the ORA Electronic Reading Room Record Date 7/3/2024 Short Title (70 char) BSO LLC. Lakewood, CO. 483 issued 07/03/2024 FEI Number 3011976853 Firm Name BSO LLC
Annovex Pharma, Inc. Lorton, VA. 483 issued 9/6/2024
Task Description Request Please post to the ORA Electronic Reading Room Record Date 9/6/2024 Short Title (70 char) Annovex Pharma, Inc. Lorton, VA. 483 issued 9/6/2024 FEI Number 3020928491 Firm Name
IPV Therapy Device Correction: Sentec/Percussionaire Updates Use Instructions for Phasitron 5 In-Line Valve to Prevent Accidental Misuse of Expiratory Port Plug
IPV Phasitron 5 In-Line Valve helps provide therapy to promote ventilation. Users need to remove the expiratory port plug before direct ventilation.
2024 Meeting Materials, Cellular, Tissue, and Gene Therapies Advisory Committee
This is the main page for the 2024 Meeting Materials for the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC).
Cellular, Tissue, and Gene Therapies Advisory Committee November 21, 2024 Meeting Announcement - 11/21/2024
This is the main page for the CBER Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) November 21, 2024 announcement and meeting materials.
Frequently Asked Questions on Popular Topics
Frequently Asked Questions on Popular Drug-related Topics
Updates on Approaches to Acceptable Intakes of Nitrosamine Drug Substance Related Impurities and Bioequivalence Assessment for Reformulated Drug Products - 11/06/2024
This interactive two-day workshop will discuss the regulatory recommendations on confirmatory testing methods for the formation of Nitrosamine Drug Substance Related Impurities (NDSRIs) , safety testi
FDA Roundup: October 1, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency.
Antimicrobial Resistance
Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR.
Ventilator Software Correction: Philips Respironics Issues Mandatory Software Correction and Updates Use Instructions for Trilogy Evo, EV300, EvoO2, and Evo Universal to Address Multiple Issues that May Impact Ventilation
Trilogy Evo, EV300, EvoO2 and Evo Universal ventilators support patient breathing. A mandatory software correction was issued to address previously reported issues.
Infusion Pump Software Correction: Fresenius Kabi USA, LLC, Issues Correction for Ivenix Infusion System Large Volume Pump (LVP) Software due to Multiple Anomalies that May Cause Delay or Underdosage of Therapy
Ivenix LVP allows for controlled administration of large volumes of fluids but software anomalies may lead to delay or underdosing of therapy.
FDA’s Unified Human Foods Program, New Model for Field Operations, and Other Modernization Efforts Go into Effect
The FDA is announcing that today, the unified HFP, a new model for field operations and other modernization efforts is now in effect. This is the single largest reorganization in the agency’s modern history
October 1, 2024
The FDA is announcing that today, the unified HFP, a new model for field operations and other modernization efforts is now in effect. This is the single largest reorganization in the agency’s modern history
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance - 11/21/2024
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final