Another snowless week, even when snow was predicted leads one to speculate that the daffodils, pushing their heads up so early, might not bloom just in time to have their heads poking up in a freakishly late blizzard.
Meanwhile Valentine’s Day beckons. Good luck to all you sweethearts or sweetheart wannabes.
And here is a bit of note to be aware of from our corner of the world this week:
- FDA Issues Draft Guidance on Biosimilar Development – For a long time, the United States has been trying to figure out how it wants to oversee the development of biosimilars and it has been a slow pathway, but a milestone was reached this week when FDA issued three new draft guidances involving critical areas in the development of biosimilars. These were “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product“, “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product“, and finally one entitled “Biosimilars: Questions and Answers Regarding Implementation of the Biologic Price Competition and Innovation Act of 2009“.
- FDA Testimony on Biosimilars and on Drug Shortages – Yesterday CDER Director Dr. Janet Woodcock delivered testimony before the Subcommittee on Health of the Energy and Commerce Committee in the House. She outlined generic drug and biosimilar user fees. She then discussed the steps FDA has taken on the drug shortage issue that included, among other things, doubling the number of staff in the Center to assist in coordination and response and working with the Department of Justice regarding issues related to stockpiling.
- Social Media Week – It’s Happening – Social Media Week is happening this next week and will include Washington, D.C. this year and it is including health care in the line up of topics and activities. The dates are February 13-17 and if you are interested in attending any of the events occurring in cities all over, check it out. I think I may be participating in one virtually that is happening in New York.
- Draft Guidance on Unsolicited Requests for Off-Label Use – Hey – remember that draft guidance the agency issued over Christmas break (and did not issue a press release about) that many said was a partial draft guidance about social media, but in fact was a draft guidance about something entirely different that just happens to mention social media? It was entitled “Responding to Unsolicited Requests for Off-Label Information About Prescription Drug Products and Medical Devices.” Yeah, that one. Well anyway, the comment period for that is still open, but I would imagine will be closing soon, so if you have a comment about it, here is the spot to do it! Comments are due by March 29.
That’s it for me this week. Have a good weekend everyone.
