FDA Policy/General
Federal Register notice: FDA is announcing an 11/16 Oncologic Drugs Advisory Committee meeting to hear an update on the agency’s accelerated approval program for oncology products. Panel members will also discuss two accelerated approval NDAs that have not met their agreed-upon milestones for completing confirmatory trials. The
Drugs
FDA commissioner Robert Califf says the agency will be increasing a mix of announced and unannounced drug company inspections in India. Califf was interviewed on CNBC-TV18’s The Medicine Box while on his first official visit to the country. Asked about the largest challenge facing India, he said expectations
Drugs
FDA medical reviewers are questioning the validity of the CodeBreak 200 post-marketing study of Amgen’s Lumakras (sotorasib) that is the basis of the company’s request to have the drug’s 5/28/21 accelerated approval converted to a full approval. A briefing document distributed in advance of
Drugs
AdvaMedDx says an FDA 6/22 guidance on a pilot program for oncology drug products used with certain in vitro tests would have benefited from advance notice and opportunity to comment. The association’s 9/28 comment letter says FDA issued the pilot as an immediately-in-effect guidance, thus
Drugs
Pfizer’s Hospira drug unit is recalling several drug lots of 4.2% sodium bicarbonate injection, USP, 5 mEq/10mL vial; 1% lidocaine HCl injection, USP, 50 mg/5mL vial; and 2% lidocaine HCl injection, USP, 100 mg/5mL vial due to the potential presence of glass particulate matter. “There
Biologics
FDA has amended the emergency use authorization of Novavax’s Covid-19 vaccine adjuvanted, for use in individuals 12 years of age and older to include the 2023-2024 formula. The updated vaccine is intended to provide protection against currently circulating variants to provide better protection against serious sickness, including
FDA Policy/General
FDA has issued Galderma a complete response letter on its BLA for relabotulinumtoxinA (QM-1114), indicated for treating moderate-to-severe glabellar lines (frown lines) associated with corrugator or procerus muscle activity in adult patients as well as moderate-to-severe lateral canthal lines (crow’s feet) associated with orbicularis
Drugs
FDA is making available a final guidance entitled “Electronic Submission Template for Medical Device 510(k) Submissions.” The document was developed as part of the agency’s commitment to develop electronic submission templates to serve as guided submission preparation tools for industry to improve submission consistency and enhance efficiency in
Drugs
FDA has issued Eli Lilly a complete response letter due to inspection problems impacting its BLA for lebrikizumab, indicated for treating moderate-to-severe atopic dermatitis (eczema). The agency letter cited findings that arose during a multi-sponsor inspection of a third-party contract manufacturer, according to the company. The
Drugs
CDER’s Office of Generic Drugs has launched a new pilot program to offer meeting opportunities to generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) determinations in their ANDAs. “The use of MIE approaches for BE establishment is increasingly prevalent, particularly in the
Devices
“Power tends to corrupt and absolute power corrupts absolutely.” (Lord Acton in 1887) [Analysis by Jim Dickinson] Suppose you had a way of speeding your product through FDA’s approval process while slowing down your competitor’s similar product. That’s what some medical device companies – like some drug companies
Drugs
FDA has approved a Novo Nordisk NDA for Rivfloza (nedosiran) injection, a once-monthly subcutaneous ribonucleic acid interference therapy for lowering urinary oxalate levels in children nine years of age and older and adults with primary hyperoxaluria Type 1 and relatively preserved kidney function. The rare genetic disease causes overproduction
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Human Prescription Drug and Biological Products — Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers — ‘Dose Banding.’” The document is intended to assist applicants in incorporating dose banding information, based on dosing information
Devices
FDA has cleared an Anumana 510(k) for ECG-AI LEF, an artificial intelligence (AI)-powered medical device to detect low ejection fraction (LEF) in patients at risk of heart failure. The device was developed in partnership with Mayo Clinic, and it screens for LEF using data from a routine
Drugs
Novartis says it will seek accelerated approval next year for its IgA nephropathy (IgAN) drug iptacopan after announcing “positive top-line results” from a planned interim analysis of the Phase 3 APPLAUSE-IgAN study (NCT04578834) at nine months. “Iptacopan, an investigational factor B inhibitor targeting the alternative complement pathway, demonstrated
FDA Policy/General
Federal Register notice: FDA is announcing the opportunity for a limited number of development programs to participate in the Support for Clinical Trials Advancing Rare Disease Therapeutics Pilot Program, which is intended to advance development of drugs/biologics that are intended to treat rare diseases. To view the notice, click
Drugs
As of Friday (9/29) evening, the ongoing Congressional budgetary impasse is on course to trigger a government shutdown this weekend. House Speaker Kevin McCarthy seems to lack the necessary votes to pass a short-term continuing resolution to keep government agencies like FDA fully running after 9/30 while
Devices
Without any progress from Capitol Hill on a legislative solution to reign in laboratory-developed tests (LDTs), FDA is now plowing ahead under a proposed rule to increase its scrutiny of such tests that have grown in use and complexity over many years. “Through increased FDA oversight, the public, including
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Technical Considerations for Medical Devices with Physiologic Closed-Loop Control (PCLC) Technology.” PCLC devices are intended for automatic control of a physiologic variable(s) through delivery of energy or substance using feedback from physiologic sensors. FDA says they may
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Graft-versus-Host Diseases: Developing Drugs, Biological Products, and Certain Devices for Prevention or Treatment.” The document discusses overall clinical development issues and critical design elements for early- and late-phase trials for the intended populations. To view the
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “‘Electronic Submission Template for Medical Device De Novo Requests.’’ The document is part of FDA’s commitment to develop electronic submission templates to improve submission consistency and enhance efficiency in the review process. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Antimicrobial Susceptibility Test (AST) System Devices — Updating Breakpoints in Device Labeling.” The document provides information about updating susceptibility test interpretative criteria/breakpoints and associated performance data in labeling for such devices in response to breakpoint changes posted on the