Department of Health and Human Services February 4, 2019 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Labeling for Human Prescription Drug and Biological Products Approved Under the Accelerated Approval Regulatory Pathway.'' This guidance discusses FDA's recommendations for developing the indication and usage statements in the prescribing information for drugs approved under the accelerated approval regulatory pathway (hereafter accelerated approval). The guidance also discusses labeling considerations for indications approved under accelerated approval when clinical benefit has been verified and FDA terminates the conditions of accelerated approval, or when FDA withdraws accelerated approval of an indication while other indications for the drug remain approved. This guidance finalizes the draft guidance of the same name issued March 25, 2014.

The Food and Drug Administration (FDA or Agency) has determined that ESBRIET (pirfenidone), film coated tablets, 534 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for pirfenidone, film coated tablets, 534 mg, if all other legal and regulatory requirements are met.

This proposed rule would update proficiency testing (PT) regulations under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to address current analytes (that is, substances or constituents for which the laboratory conducts testing) and newer technologies. This proposed rule would also make additional technical changes to PT referral regulations to more closely align them with the CLIA statute.