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News from FNH and the industry

Articles

News from FNH and the industry

Articles

News from FNH and the industry

Thanksgiving Is Your Real Launch Deadline. Check Your MLR Review Calendar.

Thanksgiving Is Your Real Launch Deadline. Check Your MLR Review Calendar.

Thanksgiving and the December holidays cancel review meetings and take reviewers out, so a January launch is really due in November. Here is how to plan your pharma launch timeline backward from the MLR review calendar, send the hardest pieces first, and decide early what moves to February.

A January launch has to be in MLR review by mid-November, because holiday-canceled review meetings, not the project plan, set the real deadline.

A January launch has to be in MLR review by mid-November, because holiday-canceled review meetings, not the project plan, set the real deadline.

A January launch has to be in MLR review by mid-November, because holiday-canceled review meetings, not the project plan, set the real deadline.

Author

Rich Roginski

(Founder, FutureNova Health)

(Founder, FutureNova Health)

Topic

Marketing Operations

Published date

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Picture the second week of December. Your January launch materials are done, the team is proud of them, and someone finally asks when the next review meeting is. The answer comes back: January. The last meetings of the year were canceled for the holidays, and half the reviewers are already out.

That launch didn't slip because the work was late. It slipped because the deadline everyone was working to was never the real one.

If you are launching in January, your real deadline is Thanksgiving. Here's why, and what to do about it this month.

Why Your MLR Review Calendar Sets the Launch Date

Before anything goes public, it goes through medical, legal and regulatory review. Most companies call it MLR, some call it PRC. Different name, same gate. Nothing ships without their sign-off.

That team doesn't review on demand. It meets on a fixed schedule, and pieces often need more than one round. Comments come back, the work gets revised, and it goes back on the agenda for the next meeting.

So the calendar that controls your launch isn't the project plan. It's the review calendar. Count the meetings between now and launch, think honestly about how many rounds each piece will need, and you have your real timeline.

Then Thanksgiving shows up. Then the December holidays. Meetings get canceled, reviewers take time off, and the ones still around are clearing a backlog. A January launch needs its materials in review by mid-November to have enough meetings left to finish.

Why Holiday Review Deadlines Catch Launch Teams Off Guard

Most teams plan forward. The brief lands, the work gets scheduled, and review is the last box on the timeline. That works most of the year, when there's always another meeting next week.

Q4 is different. The meetings thin out right when everyone is pushing to finish before year-end. Every team in the company is trying to get its pieces onto the same shrinking set of agendas.

For a biotech heading into an early launch, there's often no history to warn you. Nobody has lived through a holiday review crunch at this company yet. So the discovery happens late, usually when the work is done and the calendar isn't.

How to Plan a January Launch Backward From Review

Plan backward from the review calendar, not forward from the brief. Here's what that looks like this week:

  • Confirm the review dates now. Get the actual meeting schedule through January in writing, including any meetings already canceled for the holidays.

  • Find out who is out. Ask which reviewers are taking time off and when. A meeting on the calendar doesn't help if the person who signs off on your claims isn't in the room.

  • Send the hardest pieces first. Anything with new claims or new references goes into the earliest meeting you can get. Those are the pieces most likely to need another round.

  • Batch the simple pieces behind them. Low-risk pieces built on language that is already approved can follow as a group. They move faster, so they can go later.

  • Decide in November what moves to February. Pick now what can slip to a second wave. That's a plan. Finding out in the middle of December is a scramble.

None of this needs new tools or more people. It needs the review calendar on the table before the first piece of creative gets built.

The Bigger Point: The Review Calendar Is Part of the Brief

Faster timelines don't come from working faster at the end. They come from knowing where the real gates are at the start.

The review team isn't the obstacle. Their schedule is information. Plan around it, and the launch date you promise is one you can keep.

So pull up the review calendar this week and count the meetings. If the math doesn't work, you'll know in November, while there's still time to fix it.

Plan Your Launch Around the Review Calendar

If your January launch is tight on review time, it is better to find that out now than in December. See how we approach biotech launch marketing, or talk to us about your timeline.

FREQUENTLY ASKED QUESTIONS

Why is Thanksgiving the real deadline for a January launch?

MLR review meets on a fixed schedule, and Thanksgiving and the December holidays cancel meetings and take reviewers out. A January launch needs its materials in review by mid-November to have enough meetings left to finish.

What is MLR review?

It is medical, legal and regulatory review. Most companies call it MLR, some call it PRC. Nothing goes public without that team's sign-off.

How should you plan a January launch around MLR review?

Plan backward from the review calendar. Confirm the meeting dates through January, find out which reviewers are out, send the hardest pieces first, batch the simple pieces behind them, and decide in November what moves to February.

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Author

Rich Roginski

(Founder, FutureNova Health)

Topic

Marketing Operations

Published date

Subscribe to Signals

Stay up-to-date with the latest innovations, features, and tips in no-code website building!

By checking the box above, I agree to receive marketing communications from FutureNova Health and can unsubscribe at any time.