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ForumsPublic SquareFDA compounding enforcement update — June 2026 guidance document Page 20

FDA compounding enforcement update — June 2026 guidance document

RegAffairsDC Mon, Feb 26, 2024 at 4:00 PM 336 replies 53,782 viewsPage 20 of 20
pete_RVA
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Mar 31, 2024 at 8:47 PM#96
PharmacoVig_BOS said:
Practical: whatever you change, write down the date and the reason.

Correct as far as it goes. The part it does not cover is what to do when the honest answer is "not enough data", which is more often than anyone likes.

Happy to go further on any of that.

13 13mike_mod, SarahChen_PharmD, sarah.morrison and 10 others
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anna.melb_AU
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Apr 2024
Melbourne, AU
Apr 1, 2024 at 6:40 AM#97
PharmacoVig_BOS said:
Practical: whatever you change, write down the date and the reason.

This is exactly what I could not find anywhere else.

12 12paige_pharma, emma_london, tammy_FL and 9 others
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RegAffairsDC
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Washington, DC
Apr 1, 2024 at 4:33 PM#98

Closing the loop on my own question.

Closing this out. What actually changed my mind was the point about waiting for a trend instead of reading a single measurement, which is embarrassing in hindsight and worth saying anyway.

11 11hannah_MT, Dr.SportsMedIN, amy_econ_NJ and 8 others
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HealthEcon_DC
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Apr 2, 2024 at 2:26 AM#99

Found this through search years later and it is still the best discussion of the question, so adding one thing. Give anything pharmacological four weeks before you judge it, and give anything measured weekly a four-point rolling average before you call it a trend.

Last edited: Apr 2, 2024 at 4:26 AM
10 10TirzTom, TrialTracker_MD, JennaRN and 7 others
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quinn_sf
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Jun 2024
San Francisco, CA
Apr 2, 2024 at 12:20 PM#100
RegAffairsDC said:
What actually changed my mind was the point about waiting for a trend instead of reading a single measurement, which is embarrassing in hindsight and…

Coming at RegAffairsDC’s question from a different direction. It helps to ask what evidence would change your mind before you look at any. If nothing would, the discussion is not about evidence, and it is better to say so early than to spend nine posts discovering it.

25 18Dr.EndoEP, GraceAZ_72, carl_compliance and 22 others
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