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FDA Response Authentix has pioneered the development and application of a variety of authentication technologies for protecting pharmaceutical products and their packaging. While working through numerous anti-counterfeit solutions for manufacturers and their products, we are often asked about the regulatory implications and filing requirements for including authentication features in the product packaging as well as in the dosage itself. Following a series of meetings and communications with the FDA over the past several years, we wrote a letter requesting written clarification to the questions that we were most frequently being asked. The FDA responded with helpful guidance in the form of a letter which we are making available through our website as we believe this information will be of interest and value to pharmaceutical manufacturers as various approaches to authentication are considered. Please contact Authentix to receive login access and download the complete text to this FDA Response document. You do not currently have access to this document. |
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