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@Jennifer-Carroll said in There are a lot of clinical trials underway on Medical Cannabis. If some of these trials are successful and Medical Cannabis companies can start making claims will they be required to submit their APS's to PAAB?:

Medical cannabis is a healthcare product. Healthcare professional (HCP) advertising for medical cannabis therefore falls within the scope of the PAAB Code of Advertising Acceptance. Currently, medical cannabis advertising may not contain claims, even when directed to healthcare professionals. Advertising materials that do not contain claims are exempt from preclearance for any product category (excluding opioids).
However, specific medical cannabis products that are granted a form of Terms of Market Authorization (TMA) based on evidence relating to particular therapeutic uses will presumably be permitted to make claims in HCP advertising. Of course, those materials would exceed the exemption criteria outlined in the PAAB code and would not be exempt from preclearance.

Thanks Jennifer - this is very informative. We will share this with our customers.

I was reviewing the eFiles system requirements from the June 2013 Guidance Document "Guidance on Submission Process"

1. System requirements
   Consider the following system requirements:
    document maximum size = 20 MB
    document file format required is Adobe 8.0 or less
    video file formats accepted must be in .mov, .wmv, .swf., or .udf

Are these still accurate? Our clients use the MP4 video format most often and Acrobat DC (2015). Any guidance on whether these are supported now and the max file size will be appreciated.

Currently most Cannabis companies do not have the clinical results to support making product claims. Assuming that some of the hundreds of clinical programs are successful and Cannabis companies start making claims, will they be required to submit their APS's to PAAB?