The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled “Animal Studies for Dental Bone Grafting Material Devices–Premarket Notification (510(k)) Submissions.” This draft guidance document provides animal study design recommendations and animal study information to include to support a 510(k) submission for dental bone grafting material devices. This draft guidance may help manufacturers comply with some special controls for dental bone grafting material devices. The recommendations reflect current review practices and are intended to promote consistency and facilitate efficient review of these submissions. This draft guidance is not final nor is it for implementation at this time.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled “Handling and Retention of BA and BE Testing Samples.” This guidance is intended to provide recommendations for applicants of new drug applications (NDAs) and abbreviated new drug applications (ANDAs), including supplemental applications, and contract research organizations (CROs), regarding the procedures for handling reserve samples from relevant bioavailability (BA) and bioequivalence (BE) studies, and recommendations regarding responsibilities of each party involved in the study pertaining to reserve samples. Additionally, this guidance describes the conditions under which the Agency generally does not intend to take enforcement action against an applicant or CRO that retains less than the quantity of reserve samples specified in the regulation.

The Food and Drug Administration’s (FDA or Agency) Center for Biologics Evaluation and Research (CBER) is announcing support for the Clinical Data Interchange Standards Consortium (CDISC) Standard for Exchange of Nonclinical Data Implementation Guide–Animal Rule Version 1.0 (SENDIG-AR v1.0) on March 26, 2024, and this standard will be required in submissions to CBER for studies that start after March 15, 2027. The Agency will update the FDA Data Standards Catalog (Catalog) to reflect this change.

The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) for LYNPARZA (olaparib) Capsules, 50 milligrams (mg) held by AstraZeneca Pharmaceuticals LP (AZ), 1800 Concord Pike, Wilmington, DE 19803. AZ has voluntarily requested that FDA withdraw approval of this application and has waived its opportunity for a hearing.

The Food and Drug Administration (FDA or Agency) is announcing that it is withdrawing approval of the indications for the treatment of adult patients with advanced ovarian cancer for poly (ADP-ribose) polymerase (PARP) inhibitors under three new drug applications (NDAs) from multiple applicants. The applicants Clovis Oncology, Inc. (Clovis), AstraZeneca Pharmaceuticals LP (AZ), and GlaxoSmithKline, LLC (GSK) have each voluntarily requested that the Agency withdraw approval of the indications for the treatment of adult patients with advanced ovarian cancer for their respective PARP inhibitors and waived their opportunities for hearings. Applicant and indication details are further discussed in SUPPLEMENTARY INFORMATION.

The Food and Drug Administration (FDA, Agency, or we) has determined that ISUPREL (isoproterenol hydrochloride) injection, 0.2 milligrams (mg)/milliliter (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for ISUPREL (isoproterenol hydrochloride) injection, 0.2 mg/mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee (the Committee). The general function of the Committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements for a voluntary survey for the Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the Department of Homeland Security (DHS), which will inform the FDA Food Safety Modernization Act (FSMA), National Agriculture and Food Defense Strategy (NAFDS) Report to Congress. The proposed survey will be used to determine what food defense activities, if any, State, local, territorial, and/or tribal (SLTT) agencies have completed to date. The information will be compared to the initial baseline data previously collected by State(s).