The IU Kelley School of Business’ Center for Business of Life Sciences is hosting a conference on November 20th at IUPUI about personalized medicine. This conference will provide further insight into personalized medicine as it becomes more popular. To register, click here. For more information, visit the event page.
Health Canada, a Canadian medical device market regulator, has recently announced that all submissions must include proper labeling for Class II Medical Device Licenses. They have updated their application process to match the change. To read the full article on Mass Device, click here.
With the approval of Zarxio (filgrastim-sndz), copycat of Amgen’s Neupogen (filgrastim), there has been much speculation on the word interchangeable vs. just a biosimilar, which is Zarxio’s status. According to FDA, a product is interchangeable if it is intended to produce the same result as the original in any patient. Janet Woodcock, CDER director, spoke recently on behalf of the Senate Subcommittee about how the FDA must wait until the guidelines are bulletproof before releasing to the public. Industry is frustrated as they want to obtain the higher interchangeable status but how to prove that remains unknown until FDA publishes final guidance.
Francis Megerlin, the Berkeley Center for Health Technology, stated that the growing use of interchangeable products could cause “a long-lasting competition for chronic treatments,” while also lowering prices by insurers. It is hard to say how much prices will decrease in comparison with the original products and it will have a different effect around the world.
As FDA begins to build policy and review biosimilar submission packages, the Senate subcommittee on Primary Health and Retirement Security shows some skepticism about the time delay and difficulties that have emerged. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), responded by addressing the importance of getting the science right for the release of the first biosimilars. Read her testimony on fda.gov from September 17, 2015 here. When asked about the education of biosimilars to medical professionals, she said that they’ve “laid out a plan of education campaigns and still need to determine what people need to know.” To read more in an article on raps.org, click here.
Since Commissioner Margaret Hamburg resigned in March, it has been speculated that Robert Califf could be the new US FDA commissioner. Califf has been with FDA since February in the role as depute commissioner for medical products and tobacco.
Going forward along with this new change, the Senate is currently working toward legislation to expedite FDA drug approval process. To read Zachary Brennan’s complete article, click here. Also check out the article in Medscape.
FDA has enforced a final rule that allows the destruction of a drug that has been denied entry into the US. The final rule will help control the unwanted drugs that are illegally snuck into the US. Brennan states that the preexisting rule remains the same that the “owner or consignee of a drug valued over the current $2,500 threshold that has been refused admission will still have the option to destroy or export that drug.” The final rule provides additional structure that “for a drug valued at $2,500 or less that has been refused admission, FDA is allowed to destroy the drug without providing the owner or consignee with the opportunity to destroy or export it.”
It is estimated that the final rule will cause approximately 15,100 destructions each year and will save $901,950 annually. The final rule will take effect on October 14th. To learn more, check out Zachary Brennan’s article on RAPS.org.
Join us at the annual RAPS Regulatory Convergence in Baltimore, Maryland, from October 24-28. Learn more about how to drive regulatory excellence and visit us at our booth. Some of the biggest challenges in the regulatory industry will be addressed, such as creating and adapting regulatory frameworks, building regulatory capacity, and collaborating in countries with different tactics. To find out more information, visit the event homepage and register now.
FDA has updated its guidance on resolving disagreements and disputes between sponsors and the agency. The goal is to avoid messy disputes by holding discussions that will hopefully lead to more timely resolutions. The revisions of the guidance state more appropriate regulatory actions for a formal dispute resolution request (FDRR). To get less people involved, the sponsor must first interact with the deciding official before appealing to higher up management. To read Zachary Brennan’s full article on raps.org, click here.
Check out this article by Dr. Colin Wilsher about the newly released changes to International Good Clinical Practice (GCP). It’s important for the industry to follow the same quality standards for clinical trials and to understand the changes that have been made. ICH predicts that the final guidelines will be complete in November 2016.
For more information from the Research Quality Association (RQA) website, click here.
The 10th annual Site Solutions Summit, hosted by the Society for Clinical Research Sites (SCRS), is taking place October 8-11, 2015 in Amelia Island, Florida. This is a great opportunity to learn from industry experts and network with other clinical research entrepreneurs. Pearl Pathways’, Diana Caldwell, will be a panelist for “The Truth of its Impact for Your Site” at 4:00pm on October 10th. There is still time to register for the event. To visit the event homepage for more information, click here.