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If the firm markets other FDA-regulated products and the issue(s) affect marketed products—or the inspection extended to marketed products included on the FDA 483, then they may issue a Warning Letter These include the following statement: "Due to the deficiencies listed on the attached FDA 483 we are recommending to the center that approval ...
In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products (generic drugs). These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education in the area of ...
The FDA said it inspected the firms earlier this year and found pervasive failures with data management, quality assurance, staff tra US FDA sends warning letters to two Chinese firms for ...
The Act further sets forth a broad range of powers that the FDA may exercise in order to prevent distribution of adulterated or misbranded food. In addition to the express powers set forth in the statute, the FDA exercises certain implied powers, such as the issuance of Warning Letters and recall orders.
The U.S. Food and Drug Administration in 2023 recommended against the use of some China-made syringes as it investigated reports of leaks, breakages and other quality problems with such products ...
The FDA statement said Tandem Diabetes Care Inc. sent all affected users a letter which requested they update the software to version 2.7.1 or later, which is currently available for download in ...
In April 2005, FDA advisors requested that Pfizer place a boxed warning on their non-steroidal anti-inflammatory drug Celebrex for cardiovascular and gastrointestinal risks. [9] [10] In 2005, the FDA issued a boxed warning regarding the risk of atypical antipsychotics being prescribed among elderly patients with dementia. This advisory was ...
Of course, this technically constrained the market for Johnson & Johnson’s best-selling drug. But in the sense that the company was already selling into markets far beyond the label, it arguably didn’t matter. By the time the company implemented the FDA order in February 2002, a full 16 months later, the sales team had been prepared well.