FDA Issues Draft Guidance on Dietary Supplements
Food and Drug Administration (FDA) announced the availability of a draft guidance aimed at increasing the amount of safety information the agency has about the dietary supplement marketplace by providing the industry an opportunity to submit late new dietary ingredient (NDI) notifications. The agency intends to exercise enforcement discretion, for a limited time and in […]
Read More ›FDA Issues Final Guidance/Q&A on Importation of Prescription Drugs
This Food and Drug Administration (FDA) guidance is intended to help small entities better understand the final rule “Importation of Prescription Drugs,” published October 1, 2020 (85 FR 62094). The secretary of the United States Department of Health and Human Services issued the final rule to implement Section 804(b) through (h) of the Federal Food, […]
Read More ›New Web Page Addresses Boards’ Questions on FDA MOU for Compounded Products
Food and Drug Administration (FDA) has created a new web page to help answer questions regarding the Memorandum of Understanding (MOU) Addressing Certain Distributions of Compounded Human Drug Products from boards of pharmacy and other state agencies. The web page will continue to be updated by FDA as additional questions on the MOU are received. […]
Read More ›