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Isotretinoin may cause liver failure, therefore the patient's blood levels should be regularly tested. [9] It is known to cause birth defects due to in-utero exposure because of the molecule's close resemblance to retinoic acid, a natural vitamin A derivative that controls normal embryonic development. It is associated with psychiatric side ...
The FDA determined that the data presented in a 2022 color additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 because of a ...
In the European Union, the European Medicines Agency has jurisdiction and the relevant documents are called the "summary of product characteristics" (SPC or SmPC) and the document for end-users is called the "patient information leaflet" or "package leaflet". The SPC is not intended to give general advice about treatment of a condition but does ...
The U.S. Food and Drug Administration (FDA) announced a ban this week on red dye No. 3, or erythrosine, from foods and oral medications due to a potential cancer risk.. Food manufacturers have ...
After the FDA has banned red dye No.3, you may be wondering which drinks and candies contain it. Here's the full list—plus, when it'll be removed from shelves.
Several common factors can include: assurance of patient safety, assurance of the efficacy of the drug through the intended shelf life, [1] uniformity of the drug through different production lots, thorough documentation of all materials and processes, control of possible migration of packaging components into the drug, control of degradation ...
In 1999, Johnson & Johnson had signed a contract with a company called Excerpta Medica. Its specialty was medical marketing. Its sub-specialty was producing ghostwritten, data-filled studies on the efficacy and safety of a client’s drugs, finding the right academic scholars to be listed as the authors and then placing the articles in prestigious academic journals.
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