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250 - In addition to the automatic renewal email I just submitted, it would be AMAZING if the final PAAB approval letter (or final communication letter -- for both languages if applicable) was included in the eFile library along with the historical files. There is so much turnover in agencies, it would be incredibly helpful to have a complete document history in one location to help alleviate anything slipping through the cracks.
• Jennifer Carroll -
249 - This isn't really a question, but it would be great if PAAB were able to send an automatic email out 2 months before expiry on electronic media/websites. I am sure this is an easy thing to tag to the submission database and would be of great value to agencies and clients. Perhaps it is something that users can opt in to if there are any concerns. I hope you will consider this.
• Jennifer Carroll -
245 - It seems to be standard industry practice to post the Product Monographs for pharmaceutical drug products on the corporate websites. There are no ancillary messages provided with these, just the links to the full texts of the product monographs. In addition, these PMs are available through Health Canada's Drug Product Database to anyone who searches, and these are unrestricted. However, I understand that PAAB reviews company prepared websites specific to products, even if they only contain information straight from the PM without any editing. If it is okay to post the PMs on the corporate websites and other publically available portals, why do the designated product websites that only contain the PM information require PAAB review? Thanks!
• Jennifer Carroll -
241 - When PAAB approves a submitted piece, it provides an approval identification number. Can you advise me as to the configuration of that number? How many characters is it? Is it an alpha-numeric configuration? We are formatting a cloud-based internal review system and would like to capture our PAAB approvals accordingly. Thank you.
• Jennifer Carroll -
226 - I have been contracted by CTC Communications to aid in developing an application program on a product for a chronic arthritic condition with a high indication of depression/anxiety in patients. Like most chronic illnesses, the incidence of a mood disorder is high - this has nothing to do with the drugs treating the arthritic condition (i.e. the drugs are not causing or treating the mood disorder). In this program, no claims are made regarding the product (i.e. no claims are made that the drug helps depression/anxiety), it simply offers education and rating scales on depression/anxiety. Does this program need to be PAAB approved? Furthermore, what...
• Jennifer Carroll -
224 - I have been contracted by an agency to help develop a program for doctors on a product for an arthritic condition with a high indication of depression and anxiety in patients. No claims are made in the program regarding the drug. The program simply offers education and tools on depression and anxiety in these patients with this arthritic condition. What are the PAAB guidelines that must be adhered to in this program? Thanks!
• Jennifer Carroll -
220 - A couple colleagues have recently indicated that Annotated Product Monographs are beginning to be subjected to more stringent restrictions by the PAAB. Both indicated that the reason was that by calling out certain elements of the product monograph that it was creating "undue emphasis" on product attributes. This raises two questions: 1. How does this differ from a typical sales aid whereby charts and compelling data points are given emphasis and fairly balanced with appropriate safety information, etc. AND 2. Doesn't the fact that an annotated Product Monograph contains all pertinent balancing information in one easily accessible tool not by default ensure that appropriate caution was exercised in highlighting data? Furthermore, is this a recent development? I can recall within the last 2 years working on several of these tools with no such objections from the PAAB. Thanks in advance for your reply!
• Jennifer Carroll -
210 - Would PAAB approval be required for cards containing the Ontario Drug Benefit (ODB) Reimbursement Codes for a drug class? *content is copied verbatim from the ODB website *OBD website/URL is referenced *no mention of drug name or drug logo *no mention of pharmaceutical company *to be distributed by drug rep
• Jennifer Carroll -
162 - Please advise as to whether there are any particular requirements related to a US manufacturer providing medical information letters to Canadian physicians' unsolicited requests for information for a drug not authorized for marketing in Canada. The letters would be intended only for medical information, not for advertising purposes.
• Jennifer Carroll -
79 - Could you please provide some clarity around the definition on Formulary Kits as described in "The Distinction Between Advertising and Other Activities". Specifically, is it appropriate for a company's sales representative to distribute formulary kits to formulary committees in a hospital setting?
• Jennifer Carroll -
8 - I was curious, to your knowledge , how many companies are currently operating within the PAAB meeting report exemption , either legitimately or otherwise . I know if anybody has this information it would be likely yourself. I am curious and was hoping you could shed some light on this issue
• Jennifer Carroll