FDA Guidance Documents

As our history shows, Compliance Consultants believes the best advice we can offer our clients must be tested by direct “FDA contact” - regardless of what a “guidance document” might state. Direct contact takes more work and more confidence in our knowledge necessary to present issues and resolve conflicts with the FDA. Anyone can read a guidance document (client, sponsor or consultant) and derive a certain level of understanding. Our policy of direct contact (conversation & correspondence) with the FDA is more compelling and accurate compared to information gleamed from seminars and guidance documents.

FDA can disregard or invoke issues at will. This causes turmoil in requirements and adds risk to any submission. Many guidance document might state as a disclaimer “Contains Nonbinding Recommendations”. Yet the Guidance Documents does not separate “binding from non-binding” recommendations. Often, a sponsor has been sanctioned during a review process by the FDA for not following “recommendations”. The FDA states a recommendation and not a requirement, but a sponsor must comply with the recommendation. How does that make sense? At Compliance Consultants we test these conflicts and resolve them to the sponsor’s benefit.

Often, other statements are presented such as: This guidance document is being distributed for comment purposes only. Yet- FDA is enforcing these views and the guidance explains FDA’s current conduct.

Most regulations espoused in Guidance Documents represent “homogenized” thoughts - when if fact much is in conflict with earlier edicts in the evolution of adding definitions. Direct contact with FDA makes knowledge fresh. Guidance documents represent “stale“ information. We have never seen an instance where a our client is disadvantaged by direct contact with FDA. On the converse- it always results in a benefit.