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FDA

From FDA - Page 10
Eric F. Greenberg
Tobacco Pushes to the Front of the Line
What makes this new draft guidance frustrating is that it was published after drug manufacturers have finished configuring, testing, deploying and validating their serialization solutions in advance of the November deadline.
FDA’s Late Recommendation on Human-Readable Format
Agency issues two new draft guidances in an effort to make clinical trials more efficient while lowering costs and strengthening its ‘gold standard for safety and efficacy.’
FDA Modernizes its Approach to Clinical Trials for Drugs and Biologics
FDA, CDC offer information to safeguard foods and drugs—such as insulin—during power outages, flooding, and severe weather conditions.
Hurricane Florence: Tips on how to protect packaged foods and medications
FDA, CDC offer information to safeguard foods and drugs—such as insulin—during power outages, flooding, and severe weather conditions.
Hurricane Florence: Tips on How to Protect Packaged Foods and Medications
Although mix-ups in labeling and filling lead to recalls, packaging deserves credit for improving patient outcomes.
Pharmaceuticals: The bad, the good, and the ugly
Although mix-ups in labeling and filling lead to recalls, packaging deserves credit for improving patient outcomes.
Pharmaceuticals: The Bad, the Good, and the Ugly
A labeling mix-up, incorrect dosage cup markings, and possible microbial contamination give patients plenty of reasons to give pause.
Potentially life-threatening issues lead to voluntary medicine recalls
A labeling mix-up, incorrect dosage cup markings, and possible microbial contamination give patients plenty of reasons to give pause.
Potentially Life-Threatening Issues Lead to Voluntary Medicine Recalls
Manufacturing changes at China facility believed to be the source of the NDMA impurity—an issue that could trace back to 2012
Contamination Prompts Voluntary Valsartan Recall
FDA Commissioner Gottlieb / Image: Undark
FDA Looks to End Patent Games to Lower Drug Prices
Agency takes steps to encourage more informative labeling on prescription drug and biological products’ indications and usage.
FDA Issues Draft Guidance on Labeling Rx and Biologics Products
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