Submission Guidelines - All submissions, inquiries, requests for article ideas must be submitted to: submissions@pda.org

Highly-referenced and detailed scientific studies, new methods, and the like should be submitted to the PDA Journal of Pharmaceutical Science and Technology “Regulation” articles cover the impact of global regulatory actions in the pharma and medical device spaces. [...] The PDA Letter Editors reserve the right to rewrite headlines, select pull quotes, insert subheads, etc., and to edit unclear language, make changes per the PDA Letter style, and correct spelling and grammatical errors. [...] Here are some examples of ledes to articles published in the PDA Letter: “Has the time finally arrived when parametric release and real-time release testing can be implemented for sterile drug products without a sterilization phase, even those manufactured in aseptic processes?” “How much variation is acceptable in our products and processes? For such a simply stated question, the answer can be qu. [...] Here are examples of conclusions to articles published in the PDA Letter: “It is well worth your time to find out if there are shared audits available for materials and suppliers used for your drug substance and drug product manufacturing and to review any databases that may be available on supplier compliance status and certification. [...] ‘We have to continue the collaboration established to define how QbD and other approaches will be applied to the development and manufacturing of vaccines,’ she stressed.” 3) Take-home message/news you can use – Articles published in the PDA Letter should offer overviews of important topics within the industry, suggest solutions for common problems, or just generally provide useful, relevant infor.