Calcium Chloride Injection, USP(Updated – Currently in Shortage) Deferoxamine Mesylate for Injection, USP(Updated – Currently in Shortage) Dexrazoxane Injection(Updated – Currently in Shortage) Dextrose 50% Injection(Updated – Currently in Shortage) Diazepam Injection, USP(Updated – Currently in Sho...
The U.S. FDA issued 180 warning letters to drug andbiologicsmanufacturers in fiscal year 2023 (FY23). Of those letters, 94 were based on an on-site inspection of the company, 27 were the result of records requests sent under section 704(a)(4) of the Federal Food, Drug, and Cosmetic ...
FDA Update: January 2012 — Drug Shortages; Ranbaxy, FDA AgreementBy Lori ClapperEditor
FDA Task Force Report On Drug Shortages A complete analysis of the situation and the measures that FDA intends to implement in the near future are described in “Drug Shortages: Root causes and potential solutions: A Report by the Drug Shortages Task Force.3.In this report, the agency pres...
Drug Shortages药品短缺 Drugs@FDA Search药品@FDA搜索 已上市药品的信息可通过药品名称、原料药名称和申请号快速查询,也可通过药品的英文首字母和批准上市时间来分类查询,查询结果包括药品规格、剂型、给药途径、申报类型(如IND、NDA、ANDA)、批准状态、申请者。
FDA leaders say the advance warning will help the agency work with companies to resolve supply problems or find alternate sources of drugs that are being phased out. The U.S. has seen a spike indrug shortagesover the past six years, particularly inexpensive generic injected drugs, including pow...
美国食品和药物管理局（FDA）的工作因大量员工离职而受到阻碍，其中包括长期任职的检查员，他们找到了新...
A-List: Prioritized Guidance Documents that CDRH Intends to Publish in FY2024 Final Guidance Topics Remanufacturing of Medical Devices Medical Device Shortages - Implementation of Section 506J of the Federal Food, Drug, and Cosmetic Act Marketing Submission Recommendations for A Predetermined Change Contr...
[06/15/2017 -CDER Statement- Updates on Pfizer drug shortages- FDA] Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter Mar 21, 2016 | Audience: Pharmacy, Nursing ISSUE: Hospira, Inc. is recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02,...
Drug shortages in the US continue to affect patients on a daily basis.* Drug shortages range from something as simple as buffered aspirin to life-saving medications such as cancer chemotherapy agents, antibiotics, and emergency medications such as epinephrine. Strategies to identify and prevent drug...