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The Federal Institute for Drugs and Medical Devices (in German: Bundesinstitut für Arzneimittel und Medizinprodukte – BfArM) is the medical regulatory body in Germany. It operates under the Federal Ministry of Health (BMG). It is headquartered in Bonn, Germany. [1] Its president is Karl Broich. [2]
Generic drug manufacturers often change the way in which prescription drug ingredients are made in order to lower costs of making them, so this kind of contamination may be more widespread and undetected in generic drugs. [21] 2022–2023 United States P. aeruginosa outbreak in eye drops
FDA's role under the guidelines is to monitor company recalls and assess the adequacy of a firm's action. After a recall is completed, FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective. Generally, FDA accepts reports and other necessary recall information submitted by e-mail.
The recall involves updating instructions for use rather than removing the device, POLARx Cryoablation Balloon Catheters, from where they are used or sold, the FDA said. The FDA said the use of ...
The Food and Drug Administration (FDA) Center for Devices and Radiological Health, which regulates home medical devices, has been receiving an increasing number of “adverse event reports ...
About 10,655 devices, which were distributed between Oct. 26, 2022 and July 17, 2023, have been recalled by the company. B. Braun Medical did not immediately respond to a Reuters request for comment.
A drug recall removes a prescription or over-the-counter drug from the market. Drug recalls in the United States are made by the FDA or the creators of the drug when certain criteria are met. When a drug recall is made, the drug is removed from the market and potential legal action can be taken depending on the severity of the drug recall. [1]
(Reuters) - The U.S. Food and Drug Administration, on Wednesday, classified the recall of certain tubes made by a unit of ICU Medical as the most serious type, which could cause severe injury or ...