FDA Guidance Document

What is an FDA Guidance Document?
An FDA Guidance Document is a publication that the FDA puts out to give manufacturers (and others) insight into their current thinking around a particular topic. FDA Guidance Documents give additional clarity to manufacturers around what may or may not be acceptable and generally serves to help make decision-making easier for the company as they can more clearly assess risk v. benefit of taking a particular action.

FDA Guidance Documents can be searched on the FDA website.


Complete Response Letter

What is a Complete Response Letter (CRL)?

A Complete Response Letter is an FDA communication with a manufacturer rejecting approval of a drug following review of a new drug application (NDA). A CRL can be issued for not satisfactorily meeting any number of conditions needed for drug approval including concerns about data, risk-benefit of the drug, manufacturing sites, etc. CRLs are shared in confidence with manufacturers so reasons for the rejection are not known publicly unless a company decides to share the information voluntarily. A CRL does not preclude a company from resubmitting a drug application and it is common to see resubmissions upon addressing FDA concerns.

Functions Regulatory

Regulatory Affairs

What is Regulatory Affairs?

The Regulatory Affairs group is tasked with ensuring compliance to regulatory body requirements and setting the strategy around communications with the agency. There are several distinct functions which fall under the Regulatory umbrella within a pharmaceutical company including Regulatory Strategy, Regulatory Ad/Promo, and Regulatory Labeling.

What is Regulatory Strategy?

Regulatory Strategy team members often sit on cross-function development teams and help ensure appropriate development of clinical trials from the perspective of the local regulatory requirements and what would be needed in order to achieve the aspired labeling. There may be several things the regulatory representative would be looking for in the development of a clinical trial including choice of the right endpoints, powering for a minimally acceptable result, and having a general study design that is in line with local regulatory guidance. Regulatory Strategy also deals with communications with the regulatory body around the time of label-expansion and these team members will often travel to the agency to have discussions around development details and submission of applications for new drugs or updated labels.

What is Regulatory Advertising and Promotion (Ad/Promo)?

An important function of the Regulatory Affairs group is in reviewing materials for external communications in order to ensure compliance with regulatory guidance and to minimize the regulatory risk that the company is taking. Member of the ad/promo team are involved in various review committees (often shortened to RC) for the company and may review things including marketing materials for publication or media, deliverables for use by field teams such as sales reps, and so on.


Drug Label

What is a Drug Label?

A drug label is the approved language denoting approval of a drug by a specific regulatory body such as the FDA or EMA. The label contains information on the approved indication, dosing, safety warnings, adverse events, contraindications, pregnancy use guidance, and so on. It also contains data from key clinical trials and other studies including data on pharmacokinetics, toxicology, etc. It also includes information on safe storage and use.

The regulatory label is very important to a pharmaceutical company and the opportunity they have in increasing uptake of the drug in the real world as it can set boundaries on what marketing materials can be developed and what commercial field teams can speak about with customers. Internal review committees often contain experts from the Regulatory Affairs organization who assess potential marketing materials to ensure alignment with the approved labeling in the country.

It is common to have differing labels across the world with each regulatory body having its own requirements and processes in assessing and approving drugs and label expansions/updates.