Categories

• About

  Want to know more about the organization, strategic plan, services, and fee schedule? Ask here.

  2
  Topics
  3
  Posts

  

  For web security reasons, please register with your professional email.

  You are not required to disclose your email on your profile (this can be managed in settings). While we do encourage using your real name for your account, to promote building a community, it is not required, and you are free to use a user name of your choosing (within the limitations of the Community Forum Guidelines).

  Thank you

• Announcements

  Announcements regarding our community

  12
  Topics
  25
  Posts

  

  Happy Friday @Agency @Manufacturer

  Heading into the weekend we have two exciting things to pass along:

  The ARO Q&A Session recording is live on the Summary List of ARO and Submission Resources page

  EFiles is now accepting gif, jpg and png file formats for upload. This will help address the sizing issues identified in the Advisory – Small Space Ads

  Have a great weekend!

• Tours

  A place for patient and healthcare professional feedback.

  5
  Topics
  5
  Posts

  A

  Enter your comments here.

• PAAB Forum Tutorials

  Have questions about how to use the forum, set up your account, functionality etc.? Ask them here and we'll help you out.

  1
  Topics
  1
  Posts

  A

  Lets start with a quick registration video.

• Newsletters/Blogs

  Blog posts from individual members

  16
  Topics
  51
  Posts

  

  ARO - Sept update.jpg

• PAAB Code

  Do you have questions about particular sections of the PAAB code? Do you have insights on how sections of the code be improved? Do you want to share insights about how related standards are addressed in other jurisdictions? Post here.

  42
  Topics
  75
  Posts

  

  Good morning @gmc

  Similar to Q&A 332, p=ns data from the PM clinical trials section may be included in advertising providing there are no conclusions or claims that extend beyond that found in the PM. This is possible regardless of whether it is primary, secondary or exploratory.

• Events & Training

  Have more questions about training? Let us know.

  0
  Topics
  0
  Posts
  No new posts.
• Resources

  Guidance on Code Application

  Guidance on Submission Procedures

  Guidance on DTCA / DTCI Regulations

  Myths vs. Facts

  PAAB Icons

  Activities

  External Resources

  PAAB Logo

  Accelerated Review Options (AROs)
  107
  Topics
  165
  Posts

  D

  Q: Can you provide more details around what is considered a time-sensitive announcement?

  A: A time-sensitive announcement is a short APS focused on an announcement that requires dissemination in an urgent manner. For example, these announcements may communicate formulary coverage changes, a guideline update, product shortages, availability announcements, etc. We consider an announcement to be 2 pages of new content or less.

  Examples:
  • A banner ad with the message “Brand X is now on formulary!”
  • A short email detailing issues related to a product shortage
  • A post card intended to bring awareness to a new indication, with the message “Now indicated for the treatment of…”

  What is not a time-sensitive announcement?

  Examples:
  • An APS with a rush timeline that does not focus on any of the above announcements
  • A large APS containing diverse content containing an announcement (e.g. a website with efficacy, safety and MOA information that also contains the flash “Now on formulary”)
  • A pre-NOC submission

  If you are unsure as to whether your piece qualifies as a time-sensitive announcement, please reach out to our team.

• PAAB Q&A

  Claims & Support/References for Claims

  Non-product branded APS, pre-NOC teasers

  NHP, OTC

  CME, educational material, Reprints, reports, textbooks, independently created content

  DTCA/I, consumer secondary audience

  Electronic Media

  FYI post-approval change/preclearance exemption/what requires review/PAAB scope

  Miscellaneous

  Disclosure requirements: PI & Safety Information, Federal schedule, study parameters, reference lists

  Giveaways, Incentives & GIfts, contests, coupons (maybe activities)
  868
  Topics
  1100
  Posts

  

  Hey @gmc

  Yes, inclusion in the logo qualifies. The answer above is based on an older version of the code. The current code section 2.2 states: In all APS for pharmaceutical products, the brand or trade name, the non-proprietary or generic name and the Federal drug schedule of the product must appear in juxtaposition at least once within advertising copy and must be in good contrast and be legible.

  It can appear anywhere in the piece as long as it appears at least once.