<span class="archive__title-prefix>Posts Categorized:</span> Conference Spotlight

As a result of an early 2020 change in the Public Health Service Act definition of a “biological product,” it now includes “protein,” defined as “any alpha amino acid polymer with a specific, defined sequence that is greater than 40 amino acids in size.” Under this new definition, 89 products that were originally registered with […]

Chimeric Antigen Receptor (CAR) T cell products hold the promise of curing various cancers previously considered incurable. Since each lot of these products is specific to one patient, however, chain of custody, chain of identity, and other logistic/quality requirements are critical to ensure the correct patient receives the correct dose. [Related: Are you a cell […]

In light of the withdrawal of the United Kingdom from the European Union, there remain a number of questions regarding medical device and combination product marketing and approval. Is Great Britain the same as the United Kingdom?Where do Ireland and Northern Ireland fit in?With the United Kingdom leaving the European Union, how will this change?What […]

In FY 2020, FDA issued nearly two dozen warning letters and untitled letters to human cell and tissue product (HCT/P) manufacturers marketing products they claim will treat various diseases and life-threatening conditions—including cancer, amyotrophic lateral sclerosis, Alzheimer’s, autism, arthritis, stroke, multiple sclerosis, macular degeneration, Parkinson’s disease, chronic obstructive pulmonary disease (COPD), and many others—without proof […]

At the FDA/PharmaLink conference earlier this year, representatives from the Russian State Institute of Drugs and Good Practices, UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and U.S. FDA shared their top ten pharma company inspection findings from FY2019, revealing many similarities and a few differences (more about these similarities and differences can be read […]

Gene and T-cell therapies hold promise for treating rare and debilitating diseases that in the past had no treatment options.Yet, the time to plan and execute clinical trials and gather the evidence needed for regulatory agency approval makes those suffering from the diseases being targeted wait many years for treatment. Luxturna, the first-ever gene therapy […]

At the International GMP Conference at the University of Georgia in Athens, Georgia, in early March 2020 co-sponsored by FDA, Procter & Gamble Quality Leader and Leadership Coach Steve Greer provided a compelling, true story about a scuba diving incident and used the lessons learned as an analogy for how to ensure that pharma quality […]

In addition to the FDA Quality Metrics Site Visit Program discussed in Part 1 of this article, the agency also has a Quality Metrics Feedback Program, which aims to obtain more information about quality metrics used within the industry. FDA is interested in understanding the quality metrics that are most meaningful for companies and particular […]

This is Part 4 of our series on virtual agency inspections. In this part, former FDA investigator Ricki Chase provides her advice on how to host a virtual inspection. In Part 3, she provided insight into the best way to prepare for virtual inspections, including how to always be ready, how to review documents, and […]

This is Part 3 of our series on virtual agency inspections. In this part, former FDA investigator Ricki Chase provides her insight into the best way to prepare for virtual inspections, including how to always be ready, how to go about reviewing documents, and which documents FDA is likely to request for review. Next time, […]