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FDA warning letter. An FDA warning letter is an official message from the United States Food and Drug Administration (FDA) to a manufacturer or other organization that has violated some rule in a federally regulated activity. The FDA defines an FDA warning letter as: ... a correspondence that notifies regulated industry about violations that ...
Pharmaceutical fraud is when pharmaceutical companies engage in illegal, fraudulent activities to the detriment of patients and/or insurers. Examples include counterfeit drugs that do not contain the active ingredient, false claims in packaging and marketing, suppression of negative information regarding the efficacy or safety of the drug, and ...
Typically, rules are published within days of their adoption, meaning that consumers can expect to see the FTC’s fake review ban go into effect starting in mid-October. “Fake reviews not only ...
A case report form (or CRF) is a paper or electronic questionnaire specifically used in clinical trial research. [ 1] The case report form is the tool used by the sponsor of the clinical trial to collect data from each participating patient. All data on each patient participating in a clinical trial are held and/or documented in the CRF ...
Credit - Illustration by Lorenzo Gritti for TIME. A few months after posting a message on Goodreads about the imminent release of a new book, Indie author Beth Black woke up to an all-caps ransom ...
Fraud alerts are free and last 90 days or seven years, depending on which type of alert you choose. To reach the three nationwide credit bureaus, just visit their website or give one of them a ...
Good documentation practice (recommended to abbreviate as GDocP to distinguish from "good distribution practice" also abbreviated GDP) is a term in the pharmaceutical and medical device industries to describe standards by which documents are created and maintained. While some GDocP standards are codified by various competent authorities, others ...
NOWDiagnostics, Inc. The US Food and Drug Administration authorized the first at-home over-the-counter test for syphilis Friday. Until now, people who suspected that they had the sexually ...