Life Science Compliance Update EFPIA HCP Financial Disclosure Is Not Risk Free Thomas Sullivan Oct 17, 2016 0 A large number of pharmaceutical companies across Europe had until June 30, 2016 to disclose their financial interactions with…
CMS MACRA Final Rule to Be Released Today – Promises to Bring a New Level… Thomas Sullivan Oct 14, 2016 0 According to Politico, this morning Friday October 14, 2016 the MACRA final rule is being released by HHS. While the final…
Life Science Compliance Update What You Don’t Know About AMP Can Hurt You – Part 3 Can You Defend… Thomas Sullivan Oct 14, 2016 0 As part of a three-part series on the Average Manufacturer Price (AMP), this month’s article explores the continuing and evolving…
HHS HHS Issues Open Government Plan Thomas Sullivan Oct 13, 2016 0 On October 6, 2016, the U.S. Department of Health and Human Services announced its fourth Open Government Plan, which details…
Congress Mylan Reaches Deal Over EpiPen Rebates Thomas Sullivan Oct 12, 2016 0 On October 7, 2016, Mylan announced it reached an agreement with the United States Department of Justice (DOJ) to settle claims…
Life Science Compliance Update Getting to the Hub of the Matter: Analyzing the Compliance Needs for Hub… Thomas Sullivan Oct 12, 2016 0 Within the pharmaceutical industry there are new operating models emerging. One form of emerging arrangement is the increasing use…
FDA FDA Issues Draft Guidance on Real-World Data Thomas Sullivan Oct 11, 2016 0 In September, FDA issued a draft guidance to clarify how it evaluates real-world data to determine whether it can be used in FDA…
Uncategorized The Debate Rages On: Should Clinical Trial Data Be Public? Thomas Sullivan Oct 10, 2016 0 As we have previously written, the topic of whether or not researchers should make all the data they collect when testing drugs…
FDA Biosimilar User Fee Act (II) Performance Goals Letter Issued Thomas Sullivan Oct 7, 2016 0 The United States Food and Drug Administration (FDA) recently released its performance goals and procedures for fiscal years 2018…
FDA FDA Announces Draft MDUFA Agreement Thomas Sullivan Oct 6, 2016 0 On August 22, FDA and representatives from the medical device industry and laboratory community announced an agreement in…