It is gloomy outside. I am gloomy inside. To distract me, I will report a little of what happened this week:
- FDA Seeks Input on Development of User Fee Program for Biosimilars – The agency has enunciated principles for the development of a user fee program for biosimilar products as part of the regulatory pathway that is under construction for such products. The notice about the issue states that in addition to accepting written comments, the agency will consult with a range of groups, including scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and regulated industry. No insight given on timing for this process, which has been lengthy.
- FDA Issues “Letter to Stakeholders” on Food Safety Modernization Act – I have long been curious to know what parts of the FSMA the FDA will be implementing in light of the fact that there are many in Congress who do not see the need to provide funding for the new law. Answers have been short in coming. Mike Taylor, Deputy Commissioner for Food, issued a letter to stakeholders this week to provide an update on implementation. One thing he noted that I did not know is that there is a new part of the FDA Web site that is dedicated to FSMA. Among some of the milestones noted were the launch of the new food safety search engine, the issuance of a new guidance on fish and some new rules on importation. No word on the big ticket items.
- Alkermes to Merge with Elan Drug Technologies – Seems like it has been a while since there has been news of a merger, but some came this week when Alkermes announced that it would be merging with Elan Drug Technologies to become Alkermes plc in a cash and stock deal worth $960 million. The release states the company will hold expertise in the development of treatments for conditions of the central nervous system (CNS) and will have 25 commercialized products on the market.
That’s it for me this week folks, I’m tossing in the towel. Have a good weekend everyone.
