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281 - Please confirm the approval process for French websites. We submit the English copydecks and layouts for approvals. Once approved, we then submit the French copydecks for approval. Does the French copydeck require French layouts or can we submit the French copydeck with the English layout?
• Jennifer Carroll -
244 - 1. Is there a preference as to which comes first after a claim: the symbol (e.g. *) or the footnote number (e.g. 1)? "My product was tested and found to work."*1 or "My product was tested and found to work.1* 2. Should these be superscripted or just keyed in in a regular font (e.g. *) 3. Is there a separation required between footnote numbers and symbols? "My product was tested and found to work."1,* In AMA (American Medical Association) format the reference number would come first, separated by a comma, then the footnote symbol. The referencing would be superscripted. "My product was tested and found to work." 1,*
• Jennifer Carroll -
198 - Dear PAAB, We have been asked to prepare a slide presentation for our sales reps to use for group presentations to customers. These events vary in length from 20 to 60 minutes. It is not possible to create a separate slide presentation for each event. We propose a 'core' deck with the essential safety and efficacy information, and an 'enhanced' or 'expanded' deck with additional published data. Both would be PAAB-approved. In cases where there was insufficient time to present the larger presentation, the core slides would be presented and would be supplemented with a number of slides from the PAAB-approved 'expanded' presentation. Is it possible to use 2 approved slide decks in this manner? If so, how should they be submitted to PAAB for approval. Thanks for your interest.
• Jennifer Carroll -
145 - When is the time one can submit a docket before the Holidays? Are you open between Christmas and New Year's? If so, do you accept submissions at this time? Also, does the rule of 2 for initial docket submission still apply? Is the queue always 10 days for every first submission within that docket?
• Jennifer Carroll -
117 - I presently manage a small graphics studio and printing company and have been asked by one of my clients to arrange to get PAAB approval for certain Pharmaceutical Detail aids, Brochures and other related materials. I would like to know how to go about registering either my company or myself to be able to submit to PABB for approvals in the near future.
• Jennifer Carroll -
107 - For a launch product is the review time the same as an old product line. When a pharmaceutical submits to PAAB the promotional pieces needed at NoC does PAAB take their 10 full days for review or is it possible to take half of the time because it is a product in launch mode.
• Jennifer Carroll