Jeffrey W. Taub, M.D./Children's Hospital of Michigan - 674545 - 12/19/2023
Clinical Investigator (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 9, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA/CDER and American Association of Pharmaceutical Scientists (AAPS) Hybrid Public Workshop - 02/26/2024
This workshop will explore the current state of the science in the field of therapeutic drug monitoring (TDM) for biologic products and current clinical practice in the United States and Europe. TDM of some small molecules is commonly performed to sustain target drug levels for efficacy and to minimize safety issues. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Leiters Health Issues Voluntary Nationwide Recall of Vancomycin IV Bags, Phenylephrine IV Bags, and Fentanyl IV Bags Due to Potential for Superpotent Drug
January 5, 2024 – Englewood, Colorado, Leiters Health is voluntarily recalling 33 lots of products listed below to the user level. The recalled batches of vancomycin IV bags, phenylephrine IV bags, and fentanyl IV bags are being recalled due to the potential for superpotency because they may contain (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 8, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: January 5, 2024
The U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Authorizes Florida ’s Drug Importation Program
FDA authorized Florida ’s Agency for Health Care Administration’s Section 804 Importation Program (SIP) in accordance with section 804 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the FDA ’s implementing regulations. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 5, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Drug Safety Communication: Ongoing Safety Review of GnRH Agonists and possible increased risk of diabetes and certain cardiovascular diseases
The U.S. Food and Drug Administration (FDA) is evaluating whether Gonadotropin-Releasing Hormone (GnRH) Agonists may increase the risk of diabetes and certain cardiovascular diseases (heart attack, sudden cardiac death, stroke) in men receiving these medications for the treatment of prostate cancer. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 4, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice Web Conference - 06/04/2020
FDA and CTTI are hosting a two day public web conference to learn more about stakeholder experiences with the International Council for Harmonization Good Clinical Practice guidelines (ICH E6) and identify changes to improve its applicability to the changing clinical trial landscape. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 4, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Pharmaceutical Quality Symposium 2021: Innovations in a Changing World - 10/26/2021
Pharmaceutical Quality Symposium 2021: Innovations in a Changing World October 26-27, 2021 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 4, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar - 06/03/2021
FDA will provide an overview of the Over-The-Counter Monograph Drug User Fee Program (OMUFA) and describe the key elements of the program as it relates to OMUFA user fees. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 4, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Seraphim Z contains hidden drug ingredient
The Food and Drug Administration is advising consumers not to purchase or use Seraphim Z, a product promoted and sold for sexual enhancement on various websites, including www.amazon.com, and possibly in some retail stores. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

ENDUREA contains hidden drug ingredients
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. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

ForeverMen contains hidden drug ingredient
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 (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

Novel Drug Approvals for 2024
Innovative drugs often mean new treatment options for patients and advances in health care for the American public. (Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

FDA Roundup: January 2, 2024
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news

July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
(Source: FDA Center for Drug Evaluation and Research - What's New)
Source: FDA Center for Drug Evaluation and Research - What's New - January 2, 2024 Category: Drugs & Pharmacology Authors: FDA Source Type: news