A lot of work goes into getting a new pharma product across the finish line, especially if you’re an emerging manufacturer launching your first product.
Every element of a launch strategy is important, but certain components outweigh others.
FDA Special Designations and Programs for Pipeline Drugs: How They Impact Drug Development Deep Dive
Part 2 of 2: Special Designation Deep Dive
This is the second part of a two-part series from Two Labs Drug Pipeline Manager, Ryan Chandanais
In the first blog in this 2-part series, I provided an overview of FDA Special
Part 1 of 2: Special Designation Overview
This is the first part of a two-part series from Two Labs Drug Pipeline Manager, Ryan Chandanais
The FDA has several special designations or programs to facilitate the development of drugs treating
If you haven’t already heard, Two Labs is talking a lot about patient services this year.
After spending six months on an objective study to assess the key attributes of patient services programs – and identify the companies that are
This blog is the second part of a two-part series from Two Labs Director of Serialization, Michael Rowe.
Check out the first blog for an introductory dive into what the new DSCSA tracing requirements are.
Integration with Suspect Product SOPs
This is the first part of a two-part series from Two Labs Director of Serialization, Michael Rowe.
I had the opportunity to attend the HDA Distribution Management Conference in Indianapolis a few weeks ago. There, I led a roundtable discussion
Today’s drug pipeline is in an interesting spot. In 2022, there were only 44 novel new drugs approved, down from 58 in 2020 and 60 in 2021. The decrease is due to several reasons beyond a regulatory COVID lag: a
In 2015, the U.S. government passed the 21st Century Cures Act. In it was a provision called the ‘Open Act,’ designed to increase drug pricing transparency by requiring manufacturers to submit clinical trial results and detailed information on production and
If you haven’t had a chance to watch the on-demand webinar, “Top 3 Questions Facing New Launches,” but are curious about where to start with the pharmaceutical commercialization process, we’re giving you a recap of the highlights.