What is the Prescription Drug User Fee Act (PDUFA)? The Prescription Drug User Fee Act (PDUFA) was legislation first passed by Congress in 1992 most known for allowing the FDA to collect fees from companies in order to review new drug applications (NDAs). PDUFA is credited with speeding up review times as it allowed the FDA to scale up resourcing (including hiring of additional reviews) based on the number of drugs under review. ...
What is an FDA advisory committee meeting? The FDA may require an advisory committee meeting as part of the regulatory review process for certain drugs or indications. The advisory committee meeting consists of members of the FDA, representatives from the sponsor (pharma company), and experts chosen by the FDA (including clinicians, statisticians, etc.) Patient advocates may also be part of the process. Every drug or indication under review does not have an advisory committee. ...
What is contribution of components (CoC)? Contribution of components (CoC) refers to the impact that specific therapies that are part of a broader set of combination treatment are having for the overall outcome. For example, in a combination treatment of drug A and drug B, one may want to know what drug A means for outcomes when added to drug B compared to using drug B alone. The same question might come up for drug B as an add-on compared to drug A alone. ...
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. ...
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. ...
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. ...
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. ...