Weekly Roundup 4.8.16

I put the herbs into the garden on a warm and balmy day last weekend only to fall victim to freeze warnings a day later so brought them in the house. Warms up. Put them back outside and then another freeze warning. Bring them back in the house. Warms up. They are outside now but tomorrow there is a prediction for some snow…. Am seriously now thinking of just turning the dining room into my new herb garden….

Wherever you are, I hope there is Spring in your present, if not your near future. In the meantime, some interesting stuff happened this week and here is a little bit of it.

  • Help for Making a Mobile Health App – If you are trying to create a mobile health app you may find yourself needing help in sorting out the various regulatory compliance issues. FTC?  FDA?  HIPAA?  Alphabet soup?  This week, FTC came to your rescue when it posted on its website an interactive tool designed to help you find out which federal laws you need to follow. Produced in cooperation with HHS, the Office of the National Coordinator of Health Information Technology, the Office for Civil Rights and the FDA, the tool sets forth a series of yes/no questions that inform a developer of which laws apply to the project in question.
  • FDA Approves New Biosimilar – For only the second time, FDA announced this week the approval of a new biosimilar for use in the U.S.  Called Inflectra (infliximab-dyyb), it was approved for multiple indications – all of which were the same as the indications approved for the reference product Remicade (infliximab) which includes moderate to severe Crohn’s disease, moderate to severe ulcerative colitis and rheumatoid arthritis, and others. Indicating the need to educate the public about this emergent area of medicine, in its press release, FDA went out of its way to explain the nature of a biologic and a biosimilar and the approval process (though did not explain the naming). You can see the company press release here.
  • Growth in Number of Organic Food Producers – Not an FDA story, but an interesting food story nonetheless – USDA reports that according to data from the Agricultural Marketing Service National Organic Program, he number of U.S. certified organic operations has increased nearly 300 percent since 2002 and 12 percent between 2014 and 2015. As almost anyone who shops for food can tell you the number of stores offering organic choices has certainly increased. In the release on the topic, USDA also referenced a resource – the Organic Integrity Database run by the agency where you can look up specific organic operators and see what products are certified as organic.

That’s it for me this week. On Monday I will be sharing some thoughts with you about an important emerging issue and the real need to be planning ahead of the curve. Until then, have a good weekend everyone.

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