iwewlkws With the US government partial shutdown completing its 20th day, it is important for the regulated industry to understand that despite the event, many activities at the FDA continue as normal (as much as one can define “normal”). First, the things that don’t change. Pharmacovigilance activities continue as normal. Companies are still expected to report … Read more
Data quality and integrity issues are the most common reasons for 483s and Warning Letters. Many of these arise from misunderstanding FDA’s expectations from common issues related to data and documentation generation, correction, and storage. This week FDA released a new guidance on a Q&A format that discusses most common issues that all GMP facilities … Read more
It is no secret that FDA would like to regulate LDTs like other in vitro diagnostic (IVD) tests. FDA’s last attempt to do so in 2016 was withdrawn due to uncertain political conditions. Since then little has changed in the LDT space in terms of their use by patients, the number of providers, and it … Read more
Sponsors should look beyond GCP training to identify, groom and qualify investigators for their trials. A White paper on improving measures of investigator qualifications from the Clinical Trial Transformation Initiative (CTTI), a joint non-profit venture of the FDA and Duke University, suggests sponsors avoid repetitive training and encourage investigators to improve new skills. Investigators should … Read more
Last week FDA announced that is has implemented a standardized, electronic semi-automated inspection protocol to GMP sites for sterile injectables with plans to expand the program to all GMP inspections or audits. The new GMP inspections protocol created under the New Inspections Protocol Project (NIPP) is a culmination of several years of planning, testing and … Read more
It came to light this week that Amazon has been developing software that could mine a patient’s medical records to help doctors and hospitals to “help patients and cut costs”. Similar software are being developed by Apple, Google, probably everyone else. Healthcare data is already available in various forms electronically and what is not, can … Read more
By now practically everyone has heard about the US-trained Chinese scientist who create gene edited embryos that led to twin girls. In the hoopla, one thing that is barely discussed is that how easy it was to do it. Using commonly available CRISPR-based gene editing technology, the scientist could create World’s first genetically engineered babies, … Read more
Last week Amarin announced the results of its large Phase 3 with the fish oil product, Vascepa. The trial showed remarkable improvement in cardiovascular events compared to placebo, however, patients on placebo showed higher than normal incidence rate for the same events that Vascepa is supposed to improve raising questions if the placebo over-inflated the … Read more
Last week FDA announced new ways to strengthen its expanded access program and, in the process, highlighted what an uphill task is has due to competition from the Right-To-Try (RTT) law. FDA released an updated webpage dedicated to the Expanded Access Program. The page describes in detail how “easy” and “fast” it is to request … Read more
A review of FDA’s webpage listing available Guidance Documents shows that in the last two years, the total number of available documents is steadily decreasing. This despite FDA having a full roster of new guidance documents being created and released. A screenshot in Oct 2017 showed 3164 active Guidance Documents on FDA’s website; a similar … Read more
