FDA Policy/General
Federal Register notice: FDA is issuing an order to debar Phillip Leonowens for a period of five years from importing or offering for import any drug into the U.S. Under a plea agreement, Leonowens acknowledged that he agreed to receive, repackage, and reship prescription drugs that he received from
FDA Policy/General
Federal Register notice: FDA is announcing support for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implementation Guide—Animal Rule Version 1.0 effective 3/26. The standards will be required in submissions to CBER for studies that start after 3/15/2027. The agency will
FDA Policy/General
Federal Register notice: FDA is announcing that it is withdrawing approval of the indications for treating adult patients with advanced ovarian cancer for poly (ADP-ribose) polymerase (PARP) inhibitors under three NDAs — Clovis Oncology’s Rubraca (rucaparib), AstraZeneca’s Lynparza (olaparib), and GlaxoSmithKline’s Zejula (niraparib). The agency had earlier
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by OMB. They are: * Approval Expires Extralabel Drug Use in Animals * Premarket Notification for a New Dietary Ingredient * Food and Drug Administration Rapid Response Surveys * Application for Participation in Food and Drug Administration Fellowship Programs
FDA Policy/General
A new Government Accountability Office (GAO) report says FDA needs to evaluate its recruitment and retention efforts to support and maintain its investigator workforce. The report notes that FDA has faced challenges recruiting and retaining investigators, “resulting in fewer inspections and a less experienced workforce. For example, FDA was unable
FDA Policy/General
Federal Register notice: FDA is announcing a 4/12 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the use of minimal residual disease (MRD) as an endpoint in multiple myeloma clinical trials, including considerations regarding timing of assessment, patient populations, and trial design for future studies that
FDA Policy/General
Federal Register notice: FDA is issuing an order to permanently debar Martin Valdes from providing services in any capacity to a person that has an approved or pending drug product application. The order is based on his felony conviction for making false statements in his capacity as principal investigator responsible
FDA Policy/General
Federal Register notice: FDA is proposing to establish criteria for the lists of drug products or drug categories that present demonstrable difficulties for compounding under certain sections of the Federal Food, Drug, and Cosmetic Act. Additionally, the agency is proposing to identify the first three categories of drug products on
FDA Policy/General
CDER Office of Prescription Drug Promotion and Fors Marsh researchers say two fictitious television disease awareness and prescription drug promotional communications demonstrated that consumers might be confused about a drug’s benefits and risks. Writing in Health Communication, the researchers say (purchase required) consumers “may incorrectly equate the broadly described
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of an Air Products and Chemicals NDA and new animal drug application for medical gas helium because the company says it is no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of Bayer’s NDA for relapsed follicular lymphoma drug Aliqopa (copanlisib) after the company requested the action in response to a required postmarketing trial that did not verify the drug’s clinical benefit. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Controlled Correspondence Related to Generic Drug Development .” The document provides information on how generic drug manufacturers submit controlled correspondence requesting information related to their product development. It also describes the agency’s process for providing responses related to the
FDA Policy/General
FDA has posted a draft guidance entitled “Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs.” The document says that a minimum of three primary batches of drug product should be manufactured under current good manufacturing practice to support application approvals, noting that the batches should be of
FDA Policy/General
Federal Register notice: FDA is correcting a date in a 3/12 notice announcing the availability of a guidance entitled “Early Alzheimer’s Disease: Developing Drugs for Treatment.” The date on pages 17850 through 17851 is being corrected from “5/13/2024” to “6/10/2024.” To view the notice,
FDA Policy/General
FDA has released a cross-Center paper entitled “Artificial Intelligence (AI) & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” The paper, which applies to drugs, devices, biologics, and combination products, says “end-to-end management of AI applications is an iterative process that starts from ideation
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” The document provides an overview of the mechanisms available for device sponsors to request interactions with FDA related to medical device submissions. It also provides clarification
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Evaluation of Thermal Effects of Medical Devices That Produce Tissue Heating and/or Cooling.” The document describes relevant information that should be provided in premarket submissions to support the evaluation of thermal effects of medical devices that produce local,
FDA Policy/General
Federal Register notice: FDA is amending certain medical device regulations to update a citation for information collection and conform to the regulatory provisions to the Federal Food, Drug, and Cosmetics Act. The rule does not impose any new requirements on affected parties, and this notice is editorial in nature to
FDA Policy/General
Federal Register notice: FDA is correcting a 12/18 notice that announced the withdrawal of two NDAs. That notice indicated that the agency was withdrawing NDA 022424, Flowtuss (guaifenesin 200 mg/5 mL and hydrocodone bitartrate 2.5 mg/5 mL) oral solution held by Chartwell RX Sciences. Chartwell has
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports.” The document updates the existing E2D guidance entitled “E2D Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting,” published
FDA Policy/General
FDA associate commissioner for global policy and strategy Mark Abdoo says the Biden administration’s budget proposal for the next fiscal year requests $1 million in new funding to begin the process of expanding the agency’s foreign footprint. Speaking on 3/12 to the 25th Session of the International
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new proposed information collection entitled “Proposed Small Dispensers Assessment Under the Drug Supply Chain Security Act.” Under the Act, FDA is required to enter into a contract with a consulting firm with expertise to conduct a technology and software assessment that