The amendments are fairly light and sprinkled throughout. Most have little to no affect on the meaning or implementation of the bill–these include reformatting, corrections and minor logical adjustments–but there are a few things that are notable. Continue reading Senators Propose Amendments To S. 959→
I am a fan of attending conferences because, in addition to hearing thought-provoking presentations by knowledgeable speakers, you get to connect with the other attendees to learn what they are doing and thinking. That’s why it is so important to select the right conferences. Your goal should be to find the conferences that attract the best attendees so that you have the opportunity to make new connections and get updates from your existing ones. Of course, the speakers Continue reading Fall Conference Season Preview→
The one thing all pharmaceutical manufacturers can count on, regardless of whether or not the U.S. Congress passes a new track and trace regulation in this or future sessions, is that unit-level serialization will be a necessity on drug packages sold into the U.S. market within the next few years. We have all been paying close attention to the draft legislation that has been moving through the two houses of Congress for several months now, but there is no doubt that unit-level serialization will be required whether something passes at the federal level or not. The only questions are, exactly which year will it be required and what else will be required?
This week marks the four year anniversary of RxTrace. The first essay, published on July 4, 2009, said it all, “Welcome to rxTrace“. And almost four years later I found myself yelling at the California Board of Pharmacy with my most recent essay, “Hey California Board of Pharmacy: Your Time Is Running Out!“. In between there have been 177 other essays of varying topics and varying quality. Thanks for sticking with me.
Readership has grown significantly over the last 1 1/2 years. I don’t make readership numbers public because they probably aren’t as big as one might imagine, but the growth has been incredible. RxTrace readers are people who are looking for information about pharma and medical device regulations and the technology solutions necessary to meet them. I call it, “a comprehensive exploration of the intersection between the pharmaceutical (and medical devices) supply chains, track & trace technology, standards and regulatory compliance”. That about sums it up, I think.
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.