Skip to content
  • Categories
  • Recent
  • Tags
  • Popular
  • Users
  • Groups
Skins
  • Light
  • Brite
  • Cerulean
  • Cosmo
  • Flatly
  • Journal
  • Litera
  • Lumen
  • Lux
  • Materia
  • Minty
  • Morph
  • Pulse
  • Sandstone
  • Simplex
  • Sketchy
  • Spacelab
  • United
  • Yeti
  • Zephyr
  • Dark
  • Cyborg
  • Darkly
  • Quartz
  • Slate
  • Solar
  • Superhero
  • Vapor

  • Default (No Skin)
  • No Skin
Collapse
Brand Logo

Forum

A

akar

@akar
Agency

Forum Update: Supporting Community-Led Discussion

The forum was created as a space for shared learning and peer support, and as the community grows, we want to lean more fully into that purpose.

Going forward, PAAB will be taking a more listening-first role in forum discussions. Rather than responding immediately to every question, we’ll be encouraging members to engage with one another, share experiences, and help build collective understanding. PAAB will continue to monitor conversations and will step in to:

  • Correct any misunderstandings
  • Provide guidance when questions remain unanswered after a few days
  • Support discussions where official clarification is needed

Our goal is to foster a collaborative, trusted community where knowledge is shared and strengthened by everyone’s contributions.

Thank you for being part of the conversation.

About
Posts
5
Topics
3
Shares
0
Groups
1
Followers
1
Following
0

Posts

Recent Best Controversial

  • PAAB Exemption
    A akar

    @akar I would like to add a bit more clarity to my question - Are letters regarding product supply from a Medical Director considered PAAB exempt?

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

  • PAAB Exemption
    A akar

    Are letters from a Medical Director PAAB exempt?

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

  • PAAB exemption criteria
    A akar

    Does an email to HCPs mentioning brand name only to drive docs to order samples online require PAAB review, if no therapeutic class or indication are mentioned?

    Sampling

  • Generic product launch announcement: can we mention the original brand name?
    A akar

    Can a generic company make mention of the original brand name in their launch announcement communication to HCPs? We would like to explore two scenarios: one in which the original brand is no longer manufactured and our communication announces the launch of a generic so that docs can keep their patients on the same pill as the original molecule and a scenario in which the original brand is still available for purchase?

    Claims & Support/References for Claims
  • Login

  • Don't have an account? Register

  • Login or register to search.
  • First post
    Last post
0
  • Categories
  • Recent
  • Tags
  • Popular
  • Users
  • Groups