Alert: Siemens Healthineers Issues Correction for 3 Tesla MRI Systems
Siemens Healthineers is correcting 3 Tesla MRI systems including MAGNETOM and BioGraph mMR due to the potential for ice blockage in the magnet venting system
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FDA Pilots Faster Clarifications to Meeting Minutes
The U.S. Food and Drug Administration today announced a pilot program designed to streamline communications with sponsors following formal meetings. -
Alert: Update to Use Instructions for B Braun Hemodialysis Blood Tubing Set
B Braun Medical Inc. updates use instructions for the Streamline Bloodline Set for the Dialog+ Hemodialysis System -
FDA Modernizes Clinical Trials with Master Protocols
“FDA Modernizes Clinical Trials with Master Protocols” February 26, 2019 Issue -
National Drug Code Database Background Information
National Drug Code Database Background Information -
Office of Prescription Drug Promotion (OPDP) Metrics
FDA believes it is critically important to ensure that the promotional messages companies use to introduce new drugs are accurate and balanced as these messages form the public’s first impression of new drugs. -
“Jeni’s Splendid Ice Cream Voluntarily Recalls Passion Fruit Dreamsicle Ice Cream Bars Due to Undeclared Wheat and Soy.”
Jeni’s Splendid Ice Creams is voluntarily recalling one batch of Passion Fruit Dreamsicle Ice Cream Bars because they may contain undeclared wheat and soy. People who have an allergy or severe sensitivity to soy and/or wheat run the risk of serious or life-threatening allergic reactions if they cons -
FDA Requests Labeling Changes Related to Safety Information to Clarify the Benefit/Risk Considerations for Menopausal Hormone Therapies
Proposed removal of risk statements about cardiovascular diseases, breast cancer, and probable dementia from the boxed warnings, as well as other proposed safety-related labeling changes, to clarify the benefit/risk considerations for these drugs. -
Generic Competition and Drug Prices
FDA report demonstrating greater competition among generic drug makers can lead to lower generic drug prices. -
Patient-Focused Drug Development: Selecting, Developing, or Modifying Fit-for-Purpose Clinical Outcome Assessments
This guidance is the third in a series of four methodological patient-focused drug development guidances that describe how stakeholders can collect and submit patient experience data and other relevant information from patients and caregivers to be used for product development decision-making. -
NerPharMa S.r.l. – 06/27/2025
NerPharMa S.r.l. – 06/27/2025. Country: Italy. Record Type: 483 -
Face Rock Creamery LLC Recalls 6oz. Vampire Slayer Garlic Cheddar Because of Possible Health Risk
November 14, 2025, Face Rock Creamery LLC of Bandon, OR is voluntarily recalling 16/6oz. units of Vampire Slayer Garlic Cheddar with a use-by date of 11/04/26 because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infectio