FDA Çağrısı (İng)
The Food and Drug Administration (FDA) is announcing the establishment of a docket to receive comments on the proposed implementation of FDA’s Prescription Drug Labeling Improvement and Enhancement Initiative and on a proposed pilot project relating to the voluntary conversion of labeling to the ‘‘Physician Labeling Rule (PLR)’’ format described in the 2006 FDA final rule, ‘‘Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products.’’ The purpose of the initiative and the pilot project is to enhance the safe and effective use of prescription drugs by facilitating optimal communication through labeling. FDA is seeking public comment on this initiative, and the pilot project, particularly from stakeholders who develop and use prescription drug labeling.
Prescription drug labeling, commonly called the package insert or prescribing information, is a compilation of information approved by FDA about the safe and effective use of the product, based on FDA’s thorough analysis of the new drug application (NDA) or biologics license application (BLA) submitted by the applicant. Its primary purpose is to provide health care practitioners with the essential information needed to facilitate prescribing decisions, thereby enhancing the safe and effective use of prescription drug products and reducing the likelihood of medication errors.
In 2006, FDA published the final rule, ‘‘Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products,’’ which revised the content and format requirements for labeling to make it easier to access, read, and use (71 FR 3922, January 24, 2006). The rule is commonly referred to as the ‘‘Physician Labeling Rule’’ (PLR or final rule) because it addresses prescription drug labeling that is used by prescribers.
The focus of the initiative is to increase the number of drugs with labeling that complies with the PLR content and format requirements (§§ 201.56(d) and 201.57) for drugs approved before June 30, 2001, and for generic drugs. The initiative is anticipated to take place over several years. FDA intends to request that applicants with NDAs, BLAs, or ESs approved before June 30, 2001, and generic drugs for which the NDA for the RLD has been withdrawn (for reasons other than safety or effectiveness) voluntarily convert their labeling to PLR format and submit it to FDA for approval. FDA intends to identify and prioritize certain drugs and drug classes based on public health impact e.g., most prescribed, higher risk etc.
As part of the initiative, FDA is considering, through the use of a Government contractor, providing PLR conversion resources and services, including preparation of draft PLR labeling for applicants who request FDA’s assistance to convert labeling to PLR format.
FDA is soliciting public comments on the Prescription Drug Improvement and Enhancement Initiative till March 8 ,2013.