I have an interview for a launch brand & need a bit of help... I’ve worked on plenty of pharma brands (DTC, HCP, Payer) but never on a launch. FDA approval vs PDUFA vs launch — what do I need to know?

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1- NDA submission- company submits draft label/packaging for FDA review (10 mo, 6 mo if expedited approval) - agency has very little to do with this except packaging files

2- PDUFA/FDA Approval- approval of label/final PI

3-OPDP submission- (electronic or physical binders or both)- promo materials for FDA review/feedback (optional) 45-90days
Promotional launch- once OPDP review feedback is received and pieces are updated

Product can be made available anytime after PDUFA (depending on company supply time usually 2-3 months) “now approved” promotions until product available- then “now available” promotions until full promotional launch

Make sense?

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Also, worth noting, as many people go into planning a product launch (client side,agency side) the single most important role at the end of the day (IMO) is a strong team of writers that can follow the constant data changes, understand their impact, find solutions that keep the work on strategy, and keep their head in the game...it is a great foundation to hustle hard and earn a promotion from

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Nothing additional to add here. All sound advice. Nice to see people using Fishbowl in helpful, productive ways like this. A round of 👏 to all you good little Fishies

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That you will work 18 hour days for 3 months or more straight and not be able to take a day off.

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PDUFA is the last date the FDA can approve without being out of compliance. So often there will be million false starts pre-PDUFA (“client says 80% chance we get it today”) but then you won’t actually get label (approval) until PDUFA.

OPDP submission is a soul-crushing referencing exercise so if you are a writer I hope for your sake that the brand isn’t sub part E (brands that require OPDP subs). If it is sub part E, however, usually OPDP submission occurs a few weeks prior to expected approval, or PDUFA. Usually it’s when the SCPI - the version of the PI very close to final - has been issued, and you have to do the referencing using that version of the PI.

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OP, seriously doubt you'll be grilled too much on these specifics in this much detail at an interview but some good general points above and I suggest googling for more.
I've worked on more than one launch and fyi as well: tons of approvals don't happen at all or get greatly delayed too. No idea what you do and what level you are so hard to give more tailored advice for the interview. Definitely know working on a launch is super brutal, not gonna mince words here. But, highly educational experience to have and be able to add to your resume/book.

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You need patience. Lots and lots of patience. Labels are changing constantly, MLR always changing minds, random derivatives will pop up constantly. And nothing will be live for a year. But it’s gratifying to build something from the ground up.

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Agree with those above. To add:
If the brand is doing an OPDP submission, OPDP is kind enough to provide advisory comments on promotional campaigns and messages, but only if all those are submitted to OPDP within 5 biz days of approval. So in addition to working many hours leading up to approval, those 5 days are an all-hands-on-deck situation, to get the materials updates with the final PI and final ISI and referenced and annotated and sent to client so they can submit by the deadline. It is a time that clients work round the clock too.
Good luck at the interview.

Thank you so much everyone! This is an extremely helpful overview and I really appreciate it.

@SC1, what do you mean that PDUFA is the last date the FDA can approve w/o being out of compliance? Compliance of what specifically?

PDUFA is actually a law. From the time of application for approval they have a certain amount of time to approve or reject. So if they are going to approve hey have to do so by the end of that period (the PDUFA date).

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