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FDA Alert: FDA Reminds Compounders to Use Appropriate and Sterile Ingredients
The agency urges manufacturers, including repackagers, to clearly identify any ingredients intended for use in foods or dietary supplements on the label. Providing this information on ingredient labels could help prevent compounders from using ingredients that are not appropriate for sterile drugs and may help prevent patient harm.
[...]Indictment,USA v Wuhan Jinshang Import & Export Trading Company and Wenying Nie
United States District Court Middle District of Florida USA v Wuhan Jinshang Import & Export Trading Company and Wenying Nie Indictment Filed November 30, 2023 Read the document.
[...]Indictment, USA v Tianjin Furuntongda Tech Co and Wenxing Gao
United States District Court Middle District of Florida USA v Tianjin Furuntongda Tech Co, LTD and Wenxing Gao Indictment Filed January 4, 2024 Read the document.
[...]Indictment, USA v Hubei Shanglin Trading and Zhihan Wang
United States District Court Middle District of Florida USA v Hubei Shanglin Trading Company and Zhihan Wang Indictment Filed January 4, 2024 Read the document.
[...]Prescription Drug Affordability Board Activity through October 18, 2024
Colorado’s board reviewed proposed changes to PDAB legislation based on stakeholder testimony and board review and learned about Medicare’s Maximum Fair Price (MFP) determination. Over two meetings, Oregon’s board reviewed a draft constituent group engagement report and a UPL model that analyzed potential 2023 savings based upon MFP provided by their consultants and aggregate data collected from PBMs. The board also discussed ; policy recommendations from staff and a UPL draft report required by Senate Bill 192.
[...]October 28, 2024: DOJ hands down indictments and patients harmed by formulary change
Chinese companies and individuals indicted by the Department of Justice and a study examines how patients were harmed by the sudden removal of a medication from a drug formulary.
[...]Plea Agreement, USA v Jeremy Brown
United States District Court Western District of Vermont USA v Jeremy Brown Plea Agreement Filed September 13, 2024 Read the document.
[...]Information, USA v Jeremy Brown
United States District Court Western District of Vermont USA v Jeremy Brown Information Filed September 13, 2024 Read the document.
[...]A DSCSA-newbies guide to the recent FDA DSCSA announcement
The FDA recently announced that “connected trading partners” that have made progress in transmitting electronic data that identifies and follow medicines made for the U.S. drug supply will not be penalized if they are still working out challenges in the process. Are you wondering what that means? We can explain.
[...]FDA Alert: Pain Relief-Marketed Dietary Supplement Recalled For Containing Prescription Steroids, Muscle Relaxants, and OTC Pain Relievers
Consumers taking this product should immediately consult with their health care professional to safely discontinue use of this product. The risks of withdrawal from corticosteroids should be assessed by a healthcare professional. Only licensed health care professionals can evaluate patients for the risk, or confirm the existence, of adrenal suppression. Consumers that have product which is being recalled should return to place of purchase or discard.
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