Drugs

FDA Proposes Easing Biologics Transition

FDA is proposing a new rule that would enable the seamless transition of some biologics approved under the Federal Food, Drug, and Cosmetic Act (FFDCA) to licensed biologics under the Public Health Service Act. The proposed rule would amend agency regulations on the use of drug master files to allow certain applications for biological products approved under the FFDCA to continue incorporating by reference information on drug substances, drug substance intermediaries, or drug products contained in the drug master files after the approved applications for the products are deemed to be licenses under the Public Health Service Act on 3/23/20.

Commenting on the proposal, FDA acting commissioner Ned Sharpless says the agency has identified about 89 approved NDAs that will transition 3/23/20, and 17 of them incorporate information related to the drug and its components in drug master files. “While this is a technical detail for a limited number of products,” he says, “this presents a complication for the transition since, under our current practice, licensed biologics are not permitted to reference master files for this type of information…. The proposed rule is intended to help mitigate any unintended consequences of the transition, including the potential for drug shortages, if manufacturing were to be disrupted.”

In addition to allowing the specified products to continue to reference drug master file information, the proposal also codifies FDA existing practice that a biological product in a BLA under the Public Health Service Act may rely on a master file, except for information regarding a drug substance, drug substance information, or drug product. And it codifies the agency practice that a biological product may incorporate by reference any information, including drug substance, drug substance intermediate, and drug product information, contained in a master file.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome