FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “FDA Recall Regulations — 21 CFR Part 7.” The collection helps support implementation of FDA regulations that clarify and explain associated practices and procedures by the agency. The regulations also provide for corrective actions to be taken regarding
FDA Policy/General
Federal Register notice: FDA is announcing a 6/13 virtual public meeting entitled ‘‘Listening Session: Optimizing FDA’s Use of and Processes for Advisory Committees.’’ The listening session is intended to solicit feedback on the agency’s use of and processes for its advisory committee system. To view the notice,
FDA Policy/General
Federal Register notice: FDA is making available a draft document entitled “Considerations for the Use of Human- and Animal-Derived Materials and Components in the Manufacture of Cell and Gene Therapy and Tissue-Engineered Medical Products.” The document provides manufacturers of cellular and gene therapy and tissue-engineered medical products
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Content and Format of Composition Statements in NDAs and ANDAs and Corresponding Statement of Ingredients in Labeling.” The document is intended to assist NDA/ANDA applicants in submitting an accurate and complete composition statement in their applications and corresponding
FDA Policy/General
FDA is planning to hold a listening session 6/13 as part of its plan to revamp the use of advisory committees. “This virtual public meeting will focus on the composition of advisory committees, ways to improve the experience for members serving on committees and ways to ensure public awareness
FDA Policy/General
Federal Register notice: FDA schedules a 5/24 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss the safety and efficacy of a Novo Nordisk BLA for NNC0148–0287 for injection (insulin icodec), a long-acting insulin analog product. The proposed indication is to improve glycemic control in adults with
FDA Policy/General
Federal Register notice: FDA is establishing a public docket entitled “Promoting Effective Drug Development: Identifying Opportunities and Priorities for the Food and Drug Administration’s Office of Clinical Pharmacology.” The docket is intended to accept input from stakeholders on specific and actionable policy topics that could be prioritized, developed, and
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Laboratory Values.” The document provides recommendations about eligibility criteria for clinical trials of investigational drugs for cancer, such as selecting appropriate laboratory values as trial eligibility criteria to avoid unjustified exclusions of diverse trial
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Performance Status.” The document includes recommendations regarding expanding eligibility criteria to include patients with a wider range of performance status. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Cancer Clinical Trial Eligibility Criteria: Washout Periods and Concomitant Medications.” The document provides recommendations regarding the appropriate use of washout periods and concomitant medication exclusions. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is announcing that OMB has approved an information collection entitled “Electronic Records: Electronic Signatures.” OMB has assigned the collection with the control number 0910-0303, and its approval expires 3/31/2027. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a revised draft guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.” It is being revised to address questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing
FDA Policy/General
FDA has published a draft guidance, Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products — Questions and Answers, to address questions firms may have when developing FDA-regulated promotional labeling and ads for specified prescription biological products. The document replaces a 2/2020
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 23 NDAs from multiple applicants after they notified the agency that the drugs are no longer marketed and requested that they be withdrawn. To view the notice, click here.
FDA Policy/General
FDA has granted Day One Biopharmaceuticals accelerated approval for Ojemda (tovorafenib), a Type 2 RAF inhibitor for treating patients six months of age and older with relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG), the most common form of childhood brain tumors. “BRAF is the most commonly altered
FDA Policy/General
Federal Register notice: FDA making available its annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments” for fiscal year 2022. The agency is required to report annually on the status of postmarketing requirements and postmarketing commitments required of, or agreed upon
FDA Policy/General
Federal Register notice: FDA’s Medical Devices Advisory Committee’s Molecular and Clinical Genetics Panel announces a 5/23 meeting to review a Guardant Health PMA for its Shield blood test for colorectal cancer (CRC) screening. The proposed indication for use statement is as follows: “The Shield test is a
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Data To Support Social and Behavioral Research as Used by the Food and Drug Administration.” The collection supports agency-conducted research for understanding patients, consumers, and healthcare professionals’ perceptions and behaviors to improve FDA’s regulatory decision-
FDA Policy/General
Federal Register notice: FDA is announcing that it issued a priority review voucher to Orchard Therapeutics for its rare pediatric disease drug approval for Lenmeldy (atidarsagene autotemcel), indicated for treating children with pre-symptomatic late infantile, pre-symptomatic early juvenile, or early symptomatic early juvenile metachromatic leukodystrophy. To view the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Expedited Programs for Serious Conditions — Drugs and Biologics.” The collection supports regulations governing FDA expedited programs that are established under 21 CFR Part 312, subpart E, and are intended to speed the availability of new therapies to
FDA Policy/General
Federal Register notice: FDA is announcing the establishment of CDER’s Center for Clinical Trial Innovation, which is intended to be a central hub to support innovative approaches to clinical trials that are designed to improve the quality and efficiency of drug development and regulatory decision-making. Its mission is
FDA Policy/General
Federal Register notice: FDA has determined that UCB’s Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are