Code for FDA Submission

Posts: 37

Code for FDA Submission



Currently, our SAS programs call several macros.  Per FDA request sponsor has to submit executable non-macro programs.  Is there a way/option to convert programs without calling macros.  I tried to using MPRINT and MFILE - with these options only macros are written into another file but not the original code in the program.


Can gurus help?




Super User
Posts: 10,217

Re: Code for FDA Submission

I would be surprised if the use of macros was prohibited. I think they want you to supply all macro code, and probably have the macro definitions contained in every single .sas program file you submit, so that reviewing the code is simpler.

There are lots of proper uses for macros to make code writing efficient.


What I (as a reviewer) would never tolerate is the use of compiled macros with hidden code.

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Super User
Super User
Posts: 9,599

Re: Code for FDA Submission

Is this actually a requirement now?  Last I heard they were debating it, and the analysis reviewers guide (or other doc) should show the model or logic used in the code, but actual executable code itself wasn't required.  It would be interesting if it is, as we for instance have a lot of old compiled hidden macro libraries from third parties - who will refuse to provide you with code - which don't work anymore.  

If it is the case, then even more reason to insist on completely open source, plain text files for all code.

So I would check what "submit executable non-macro programs" exactly means, to me non-macro means you would need to expand all the code which isn't worth anyone's time doing, nor would help anyone.  Much more likely they want to see some algorithms.

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