Department of Health and Human Services June 8, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) permanently debarring Analay Rico from providing services in any capacity to a person that has an approved or pending drug product application. FDA bases this order on a finding that Ms. Rico was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product under the FD&C Act. Analay Rico was given notice of the proposed permanent debarment and was given an opportunity to request a hearing to show why she should not be debarred. As of March 3, 2023 (30 days after receipt of the notice), Ms. Rico had not responded. Ms. Rico's failure to respond and request a hearing within the prescribed timeframe constitutes a waiver of her right to a hearing concerning this action.

The Food and Drug Administration (FDA, Agency, or we) has determined that BUSPAR (buspirone hydrochloride) capsules, 5 milligrams (mg), 7.5 mg, 10 mg, and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDA) for buspirone hydrochloride capsules, 5 mg, 7.5 mg, 10 mg, and 15 mg, if all other legal and regulatory requirements are met.

The U.S. Department of Health and Human Services (HHS) announces the next meeting of the President's Advisory Commission on Asian Americans, Native Hawaiians, and Pacific Islanders (Commission) and the solicitation of written and oral comment regarding the advancement of equity, justice and opportunity for Asian American, Native Hawaiian, and Pacific Islander (AA and NHPI) communities. The meeting is open to the public and will be held in Honolulu, Hawaii. Virtual attendance will be available through livestream for July 6; in- person attendance is available for July 7, 2023. The Commission is working to accomplish its mission to provide independent advice and recommendations to the President on ways to advance equity, justice, and opportunity for AA and NHPI communities.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #279 entitled ``Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting; Draft Guidance for Industry.'' This draft guidance describes an approach to satisfy the requirements for the completion of the Bioequivalence technical section for generic Type A medicated articles (TAMAs) containing poorly soluble, locally acting, active pharmaceutical ingredients (APIs) that have little to no systemic absorption, and for which blood level studies are not considered appropriate to demonstrate product bioequivalence. The suggested approach described in this draft guidance uses a combination of in vitro and in vivo data to support a determination of bioequivalence to address the unique challenges associated with demonstrating bioequivalence of TAMAs containing poorly soluble, locally acting APIs that have little to no systemic absorption.