The dog days of Summer are upon us. No matter what one does, it seems, lawns turn a faded color. Bright daisies and black-eyed Susan flowers dance lazily in gentle breezes. Gazpacho can be a complete meal. The porch swing, while inviting, is only a place to sit for a short while as the ceiling fan does its best to keep us cool. We take solace in the fact that many are on vacation and commutes are nice and easy with both the Congress out and school out.
In the meantime, a bit of what happened this week:
- Approval of 3-D Printable Pill – Aprecia Pharmaceuticals announced this week that it had received FDA approval of the first 3-D printed drug product. The drug is called SPRITAM (levetiracetam) indicated as an adjunct therapy for adults and chlidren with epilepsy and utilizes a technology platform to print a porous formulation of the drug that rapidly dissolves when taken with liquid. The system can deliver high doses of drugs and may be useful for patients who have trouble swallowing pills. And it provides us with one more way 3-D printers can be used.
- Guidance for Finding Guidance – This week the FDA blog – FDA Voice carried a posting regarding a new tool for use in finding guidance documents when you need to. According to the posting, there are over 3100 guidance documents which represent the agency’s thinking on a wide range of issues under FDA’s jurisdiction. The tool is referred to as a dynamic search list – and will afford you access to the guidance no matter where it resides on the FDA site. I tested it out doing a search for “social media” and two guidance documents – one related to character space limitation and one related to correcting third party misinformation came up. But there are other guidances that discuss some aspects of social media – such as the 2011 guidance on Responding to Unsolicited Requests About Off-label Information and the one on Fulfilling Regulatory Requirements for Post-Marketing Submission of Interactive Promotional Media so don’t assume a search term that you enter that is broad will necessarily capture all subject matter. That said, the tool seems to make finding specific guidances much easier.
- OPDP Issues First Warning Letter of 2015 – While there have been 7 Untitled Letters issued by the FDA office that oversees drug promotion regulation, in July the first Warning Letter was issued. One of the violations cited in this letter concerned a professional sales aid that did not contain any risk information but did contain a statement that the sales aid was to remain in the possession of the professional sales representative. The agency did not find the fact that the sales aid was not to be distributed to be a mitigating factor. While this violation was of particular interest, other violations can be seen in the letter.
That’s it for me this week folks. Have a wonderful summer weekend.