Drugs
Bipartisan legislation has been introduced in the House of Representatives to help “address drug-gene interactions” and to ensure that Americans have access to treatment personalized to their needs. Introduced by Representatives Eric Swalwell (D-CA) and Dan Crenshaw (R-TX), the Right Drug Dose Now Act will “enable the
Drugs
FDA has issued Contract Pharmaceuticals Limited a Form FDA-483 citing one observation after its Mississauga, Canada facility was inspected 10/2023. FDA investigators cited the firm for failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. Specifically, the agency said Contract Pharma
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies.” The document provides recommendations to applicants and testing site management on maintaining data integrity for the clinical and bioanalytical portions of bioavailability and bioequivalence studies submitted in support of drug-
Drugs
An HHS white paper on “Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States” discusses some of the roles that FDA plays and wants to play in responding to drug shortages. The paper says the agency’s response focuses on the intake of information
Devices
FDA has approved Abbott’s TriClip, which it describes as a “first-of-its-kind” transcatheter edge-to-edge repair system that is designed for treating tricuspid regurgitation (leaky valve). Approval is based in data from the TRILUMINATE Pivotal trial that evaluated the safety and effectiveness of the TriClip system
Devices
FDA says it has qualified a new tool for the evaluation of lethal arrhythmia alarm detection algorithms used in hospital-based patient monitoring systems. An online announcement says that under the Medical Device Development Tools program, the University of California San Francisco Lethal Arrhythmia Database Medical Device Development Tool was
Drugs
FDA has approved Basilea Pharmaceutica International’s Zevtera (ceftobiprole medocaril sodium for injection) to treat adults with Staphylococcus aureus bloodstream infections, including those with right-sided infective endocarditis; adults with acute bacterial skin and skin structure infections; and adult and pediatric patients three months to less than 18 years old
Drugs
Lenz Therapeutics says it will file an NDA for aceclidine eye drops in a few months after reporting Phase 3 study results for treating presbyopia, which affects near vision in people over 45. The data from CLARITY 1 and 2 trials showed that LNZ100 (1.75% aceclidine) achieved the primary
Devices
FDA has granted Prenosis a de novo marketing authorization for its Sepsis ImmunoScore artificial intelligence (AI)/machine learning software as a medical device to guide rapid diagnosis and prediction of sepsis. The company says this is the first authorization of an AI diagnostic tool for sepsis, a “complex condition that
Drugs
The CDER Office of Pharmaceutical Quality (OPQ) annual report for 2023 says it supported 55 novel drug approvals, including 17 biotechnology products. The report also credits OPQ with 359 expedited quality assessments to address drug shortages, 28 priority assessments to address orphan diseases, and 65 pre-license inspections in 10
Drugs
AdvaMed says it appreciates that FDA issued a revised draft guidance on questions and answers about conducting remote regulatory assessments (RRA) and continues to support the concept of RRAs. In its comment letter, AdvaMed says it is “important that RRAs be implemented in a manner that both serves FDA’s
Drugs
An 11/6-11/10/2023 FDA inspection at the Betone SA de CV drug manufacturing facility in Zapopan, Jalisco, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 3/21 Warning Letter says specific violations were: * failure to have, for each batch of
Devices
FDA says its 6/7-6/13/2023 inspection at Agena Bioscience in San Diego, CA, determined that the firm manufactures the MassARRAY4 system and iPLEX HS chemistry panels in vitro diagnostic products, including the iPLEX HS colon panel. A 3/21 Warning Letter says the colon panel is adulterated
Devices
An 11/1-12/11/2023 FDA inspection at the Beckman Coulter facility in Chaska, MN, found Quality System Regulation violations in the firm’s manufacturing of the DxI 9000 Access Immunoassay analyzer instrument system and assays. A 3/15 Warning Letter says specific violations were: * failure to adequately establish
Drugs
FDA has posted its report on potential signals of serious risks/new safety information identified by the Adverse Event Reporting System in the fourth quarter of 2023. The post contains 20 signals. FDA says it approved labeling changes for five of the items and is evaluating the need for regulatory
Drugs
Rep. David Schweikert (R-AZ) has introduced the Substance Therapy Designation Act that he says would allow for opioid, cocaine, methamphetamine, and alcohol treatments to be eligible for an FDA breakthrough designation. “The designation significantly expedites the development and review of such treatments,” he says in a statement (includes a
Drugs
FDA has released a draft guidance entitled “Data Integrity for In Vivo Bioavailability and Bioequivalence Studies” that provides recommendations to applicants and testing site management on maintaining data integrity for drug-related clinical and bioanalytical portions of bioavailability (BA) and bioequivalence (BE) studies submitted to CDER. The recommendations in the
Biologics
Gritstone Bio reports mixed data from an ongoing, signal-seeking Phase 2 portion of a Phase 2/3 study evaluating Granite, a personalized neoantigen cancer vaccine for front-line use in metastatic microsatellite-stable colorectal cancer (MSS-CRC). “Circulating tumor DNA (ctDNA) analysis over several months of treatment shows the
Drugs
Eli Lilly, which recently obtained FDA approval for its Zepbound (tirzepatide) as a weight-loss drug, says that as the agency revises its 2007 guidance on developing products for weight management it should clearly state that obesity is a complex, chronic disease. In a comment letter, Lilly says such a
Devices
FDA appears to be increasing scrutiny over CooperSurgical and its manufacturing facility in North Tonawanda, NY, where Paragard (intrauterine copper contraceptive) is made, according to a report by Spotlight on America, which describes itself as “a national award-winning investigative news franchise airing on 90+ ABC, CBS, NBC, FOX, CW
Drugs
FDA has released a guidance entitled “FDA Regional Implementation Guide for E2B(R3) Electronic Transmission of Individual Case Safety Reports for Drug and Biological Products.” The document is intended to assist submitters in transmitting electronic individual case safety reports (ICSRs) and attachments to the FDA Adverse Event Reporting System (FAERS)
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Draft Guidance on Oxymetazoline Hydrochloride.” The document, when finalized, will provide product-specific recommendations on, among other things, the design of bioequivalence studies to support ANDAs for oxymetazoline hydrochloride ophthalmic solution, which is used in patients with blepharospasm to