On October 26, 2020, a business plan was endorsed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) that eventually resulted in a holistic revision to ICH Q9, “Quality Risk Management,” the “R1” of the framework. The four areas of concern were identified as: High levels of subjectivity in risk assessments […]
In today’s rapidly evolving technological landscape, pharma and biotech businesses are increasingly looking to leverage artificial intelligence (AI) to gain a competitive edge. However, before diving headfirst into AI, it is crucial to lay a solid foundation. One of the most effective ways to do this is by implementing a Unified Namespace (UNS). This blog […]
Last week, I had the privilege of attending The Indian Pharmaceutical Alliance’s 10th Global Pharmaceutical Quality Summit in Mumbai. Not only was the event loaded with excellent content presented by leaders of the generics industry, it also provided invaluable chances to discuss innovation and opportunities for the industry with individuals in quality from around the […]
Since 1976, the International GMP Conference has been co-sponsored by the University of Georgia College of Pharmacy and the U.S. Food & Drug Administration. However, this year, through no fault of the Agency, the FDA was unable to attend. This was unfortunate (to say the least), especially as this public-private collaboration amongst a number of […]
There is a hint that the “pause” or freeze on communications from the FDA may be starting to thaw. This morning, a CDER Small Business and Industry Assistance (SBIA) Webinar titled Navigating Controlled Correspondences to Support Generic Drug Development, to be held on February 27, 2025 from 1:00 to 3:30 p.m., was posted with a request […]
Deflecting responsibility is a timeless tactic for the young. While it was easy to simply point the finger and say, “I didn’t do it, they did,” as children, this approach is not viable in the life-sciences industry when things go awry. In this sector, we can’t simply transfer our responsibilities without written agreements and clear […]
Artificial intelligence is advancing at an unprecedented speed, with breakthroughs happening almost daily. One of the most fascinating—and potentially unsettling—developments is the idea that AI systems could replicate themselves. Picture an AI model so advanced that it can create a duplicate of its own functionality. What once sounded like pure science fiction is now inching […]
In the quest for effective treatments for their disease, cancer patients often require several different modalities and treatment types. Radiopharmaceutical products are one of those forms of treatment, and treatment with these types of products requires expedient delivery to ensure that the required dosage is administered to patients as radioactive decay may result in a […]
When a firm receives an FDA 483 finding of “does not follow Standard Operating Procedures (SOPs) for performing X GMP activity,” the immediate response is often to revise or update that specific SOP with more detailed instructions. While this might seem like the right thing to do for a quick fix, it is crucial to […]
Revision 2 of the FDA Guidance for Industry “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers” was published on January 6, 2025 and it finalizes the previous draft version. This is a procedural guidance that applies to medical products regulated by CDER, CBER, CDRH, […]
