Quite a few companies in FDA regulated industries are experiencing “Dynamic Shock.” After handling their operations and quality assurance in the same manner for years, they are suddenly faced with severe findings on a 483, or are even issued a warning letter. Dynamic Shock stems from the constantly shifting nature of the industry and the practical policy changes the FDA makes, with the goal of constant industry improvement. These changes often take the form of industry guidances, which reflect the FDA’s current mindset about various aspects of certain industries. Some guidances receive large amounts of attention in the media and are difficult to overlook. Others however, are less publicized and are missed by some companies, resulting in negative findings during an FDA site visit.
The FDA does make serious efforts to ensure that regulatory information is readily available to the public. Fda.gov contains a vast wealth of literature, including industry guidances. However, because of the sheer volume of information housed on the site, it can sometimes be difficult to find the information relevant to you. To help combat this difficulty, the FDA has opened channels of communication to help guide companies to the right source of information, and even has a dedicated CDER Small Business Assistance Office of Communications. There is also a more general drug industry information channel. Another important aspect of staying current with industry regulations is to monitor 483 reports, warning letters, and enforcement actions by the FDA. The FDA makes this information easily accessible in the reading room section of the site, and even has a mailing list that anyone can subscribe to that automatically sends enforcement reports for specific categories. By monitoring the types of issues being flagged by the FDA, one can get a very good idea of issues that may exist for a specific company.
One of the best information resources an FDA regulated company can leverage are consulting agencies. Often, consultants have specialized knowledge garnered from hours of painstaking research undertaken for previous projects. Many consultants have a wide variety of experience in FDA regulated areas, and can offer pragmatic compliance solutions to keep up with new guidances. Leveraging these unbiased outside opinions can make the difference between either upholding a long history of good standing with the FDA, or having serious negative findings during an FDA site visit. One of our goals at Globiox is to continuously cultivate our knowledge and expertise in regulatory affairs, so that we can continue to be a resource for high quality solutions and advice to our customers. We would love the opportunity to be your partner in this area.