I love risk, and risk is something I live in every single day. I think it's really important to understand that when people talk about risk and FDA risk management, it's not about the elimination of all risk.... Read more
Guidance Inartfully Mixes New and Old Expectations – Creates Confusion for Drug and Biologics Manufacturers As the COVID-19 pandemic continues, FDA continues its efforts to steward public health decision-making in an increasingly challenging regulatory climate. FDA’s most recent... Read more
For life science manufacturers concerned about third-party access to facilities, we have been recommending they add pre-entrance gowning to existing gowning procedures and extend the gowning envelope to the building exterior. This can be accomplished through an expedited... Read more
The Opportunity Cost of Swapping Staff from One Project to Another: The need to constantly swap internal resources to keep projects on-track can severely limit FDA-regulated companies from maintaining quality and staying in compliance. Instead of improving operations,... Read more
Cannabidiol (CBD) is the latest “it” product. Companies across the US and internationally are eager to manufacture CBD or incorporate CBD into a variety of other products. Despite a recent Draft Guidance issued by FDA on July 22, 2020... Read more
The FDA has long taken a risk-based approach to manufacturer GMP compliance expectations and enforcement actions, as well as requiring pharmaceutical and medical device manufacturers to do the same in their quality system operations. Similarly, companies can also... Read more
Being able to present data that the FDA believes it can trust is critical to making it through an inspection unscathed. Medical product manufacturers must provide myriad data to agency investigators, which expect that data to meet its... Read more
Data drives the pharmaceutical and medical device industries. It informs the manufacture and release of medical products to patients and consumers, and determines which products are approved for sale in the US and other markets. And regulators, like... Read more
