Without mentioning any clinical data or making any clinical claims, would it be permitted to compare the methodologies of the pivotal studies of 2 products. For example, Product A's study has a primary efficacy endpoint at week 1 and Product B's has a primary efficacy endpoint at week 8. Or, something, like Product A included patients over 65 and Product B excluded them.
C
charlton
@charlton
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Posts
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Side-by-side comparison of clinical study methodologies -
Websites for controlled drugsThanks, Jennifer. Love the dog, by the way!
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Websites for controlled drugsAssuming that a url is only provided via a PAAB-approved APS, if a website is being designed for a controlled drug, are there any differences in what is allowable versus for a prescription product. For example, can the brand name be on the gate page, can there be a patient section (DIN gated) where the contents of a PAAB-approved Patient Brochure are provided? Are there any specific restrictions that affect controlled drugs when it comes to websites?
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Promoting to hospital buying groups/administratorsAre there any restrictions when it comes to promoting prescription medicines to hospital buying groups or hospital administrators? How are they categorized on the consumer vs patient vs HCP spectrum?
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Definition of a pragmatic trialForgive my ignorance but as pragmatic trials are relatively new, it would be helpful to know how you define "pragmatic trial" and where they fit in the taxonomy of clinical research (e.g. experimental vs observational; and if observational, analytical vs descriptive).
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Conference booth regulationsCan a pharmaceutical company have a product branded booth at a conference where the disease state in question is off label? For example, could a company promoting an antihypertensive have a booth at an obesity conference?
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FYI for a price update?We have a recently approved APS that includes the price of the product. If the price changes, and we make just that one change to the piece, can this be handled with an FYI email?
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Brand name onlyThe recent PAAB Advisory on Small Space Ads is very welcome. However, it doesn't quite answer a question I have. If I have a static (one frame) banner ad, and I only want to direct the viewer to a landing page where we offer further information and samples, can I use the brand name only, without the indication and fair balance? There would be no claims.
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Patient case studiesThanks for your reply. However, I'm still not clear about whether the patient is required to have been one of the patients included in the trial included in the PM.
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Patient case studiesAre real patient case studies, used to illustrate before and after effects, which were not taken from the efficacy studies in the PM, acceptable in a branded piece?