Conversation: Darshan Kulkarni on the FDA Draft Guidance

Last week Pixels & Pills’ editor Briana Campbell had the pleasure of sitting down for a Skype chat (so the quality is a little lower than our normal, professional videos) with Dr. Darshan Kulkarni (@FDALawyers) of the Kulkarni Law Firm in Philadelphia. And while the questions answered in the conversation don’t constitute legal advice and should not be constructed as such, we were very happy to get the thoughts of a lawyer on the recent FDA draft guidance. And to have him address some questions that you all had put forth on Twitter.

Further information on some of the things Darshan touches on can be found in the following sources:

The Park Doctrine

Par Pharmaceutical versus the FDA

FDA’s Cease and Desist to Triple Flu Defense

One more time, Jonathan Richman’s handy flow chart

He also mentioned to us, after we’d turend the camera off, that the FDA uses draft guidance as a way to express their thoughts on certain issues without the rigor of regulations. There is much draft guidance out there that never becomes finalized. To us, this means that we should take the guidance for what it is – all we are getting on emerging electronic/social media platforms at this time. And maybe ever.

Do you have questions for Dr. Kulkarni? Thoughts on this conversation? Leave them in the comments and we’ll continue the discourse.



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