Biologics
Iovance Biotherapeutics has delayed until the first quarter next year its completion of a rolling BLA submission for lifileucel, an investigational tumor infiltrating lymphocyte therapy for patients with advanced (unresectable or metastatic) melanoma who progressed on or after prior anti-PD-1/L1 therapy, and targeted BRAF/MEK inhibitor therapy.
FDA Policy/General
Federal Register notice: FDA has announced a 12/7 public meeting entitled “Animal Drug User Fee Act” to discuss proposed recommendations for reauthorizing the Animal Drug User Fee Act for fiscal years 2024 through 2028. To view the notice, click here.
FDA Policy/General
Senator Bernie Sanders (I-VT) is expected to become chairman of the FDA-watching Health, Education, Labor and Pensions (HELP) Committee after current chair Patty Murray (D-WA) signaled she is seeking the chair position of the chamber’s Appropriations Committee. “As chairman of the committee, he will focus on
Drugs
Due to increased demand for amoxicillin oral powder and subsequent shortages, FDA 11/18 issued an immediately in effect guidance on the preparation of beta-lactam oral antibiotic suspension products compounded by pharmacists. The agency says it has received requests for clarification about preparation of compounded versions of the products
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they told the agency the products were no longer marketed and requested they be withdrawn. To view the notice, click here.
Drugs
Comments are due by 11/22 on an FDA proposal published 7/25 to expand the National Drug Code (NDC) from 10 to 12 digits. An 11/17 CDER Small Business and Industry Assistance Webinar explains the reasons for the proposed change and describes the five-year implementation period that
Drugs
FDA has warned seven dietary supplement manufacturers that they are illegally selling products that claim to cure, treat, mitigate, or prevent cardiovascular disease or related conditions such as atherosclerosis, stroke, or heart failure. An agency notice says FDA is urging consumers not to use these or similar products because they
Drugs
FDA has approved Lilly’s Rezvoglar (insulin glargine-aglr) as an interchangeable biosimilar insulin product to Sanofi’s Lantus (insulin glargine). The agency says Rezvoglar is a long-acting human insulin analog indicated to approve glycemic control in adults and pediatric patients with diabetes mellitus. FDA previously approved Rezvoglar as
Drugs
Nine Democratic senators led by Sen. Elizabeth Warren (D-MA) are asking FDA to take three specific steps to protect and expand access to medication abortion. In an 11/17 letter to FDA commissioner Robert Califf, the senators ask that the agency: * finalize the updated Risk Evaluation and Mitigation Strategy
Drugs
Members of the FDA Cardiovascular and Renal Drugs Advisory Committee 11/16 voted 9-4 to back Ardelyx’ tenapanor as a monotherapy in kidney disease patients and 10-2-1 for its use in combination with phosphate binders. FDA medical reviewers had raised concerns about the drug’s treatment effect
Biologics
Pfizer and BioNTech have begun a Phase 1 study of their next-generation Covid-19 vaccine that they say is designed to “enhance SARS-CoV-2 T cell responses and potentially broaden protection against Covid-19.” The study is part of the companies’ strategy to generate more robust, longer-lasting,
Drugs
FDA Oncology Center of Excellence director Richard Pazdur says the agency wants to see multiregional trials in oncology submissions that represent the major International Conference for Harmonization (ICH) regions in the world. Speaking at the 2022 Friends of Cancer Research (FOCR) in Washington, DC 11/17, Pazdor expanded on a
FDA Policy/General
FDA commissioner Robert Califf and Oncology Center of Excellence director Richard Pazdur say FDA employees, who have been working from home during the pandemic, can likely return to the agency headquarters campus in White Oak, MD under a flexible hybrid approach in the near future. During a joint conversation at
Devices
FDA has classified as Class 1 an Insulet recall of its Omnipod DASH Insulin Management System due to battery issues. The device is used to deliver insulin at set and variable rates to manage diabetes in people who need insulin. According to an agency notice, the recall was initiated after
FDA Policy/General
Federal Register notice: FDA is making available additional draft and revised draft product-specific guidances for use by ANDA sponsors. The documents provide recommendations on, among other things, the design of bioequivalence studies to support ANDA submissions. To view the notice, click here.
FDA Policy/General
FDA is launching a cybersecurity modernization action plan (CMAP) to enhance its current cybersecurity defenses to address the ever-evolving threat landscape and protect the vital data supporting the agency’s regulatory decision-making. Writing in an FDA Voices post, chief information officer Vid Desai and chief information security officer
FDA Policy/General
Federal Register notice: FDA has announced its preliminary assessment that certain types of naloxone hydrochloride drug products may be approvable as safe and effective for nonprescription use to counteract opiod overdose. It found that naloxone nasal spray up to 4 milligrams (mg), and naloxone autoinjector for intramuscular or subcutaneous use
Drugs
Worldwide academic medical center researchers led by Abass Alavi from the Hospital of the University of Pennsylvania Department of Radiology say FDA should pause its approval of Biogen’s Aduhelm (aducanumab) to treat Alzheimer’s disease. Writing in a Journal of Alzheimer’s Disease commentary, Alavi says the approval should
Drugs
The California Court of Appeal has upheld federal preemption in a case involving the heart drug amiodarone. Attorney Steven Boranian (Reed Smith) writes in a Drug & Device Law Blog post that the plaintiffs in the case alleged that they experienced severe effects after their doctors prescribed amiodarone off-label.
Biologics
FDA has denied in full citizen petitions filed on 3/24/21 and 8/12/22 by the Informed Consent Action Network relating to certain provisions of the emergency use authorizations (EUAs) for Covid-19 vaccines. The agency response lists the lengthy and detailed requests made in the petitions. The
Drugs
Four Morrison Foerster attorneys say a panel on “Compliance and Cybersecurity Challenges in Clinical Trial Enforcement” held on 11/2 at a Food and Drug Law Institute conference featured a high-ranking attorney from the Department of Justice consumer protection branch and other regulatory compliance leaders to discuss key trends
Drugs
CBER has issued two new Standard Operating Policies and Procedures (SOPP) to guide Center staff in dealing with resubmissions to an application or supplement and actions on biological product licenses. SOPP 8405.1, Procedures for Resubmissions to an Application or Supplement, is a guide for the categorization and processing of