Drugs
CDER researchers are developing a quantitative framework to describe the exposure-response relationship and the difference in exposure-response between populations to support extrapolation of efficacy in drug development programs from adults to pediatric populations. An online post says there are often challenges in pediatric drug development that lead investigators
Devices
The Sedgwick Recall Index says Quarter 2 recall events soared 34% to a two-year high from 200 events in the last quarter to 268 events in Q2. The document says the number of affected units dropped, however, by 96.8% to 10.1 million units, the lowest quarter in
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations — Premarket Notification (510(k)) Submissions.” The labeling recommendations are intended to promote the safe and effective use of such products. To view the notice, click here.
Drugs
FDA has lifted its partial clinical hold on the TakeAim Lymphoma Phase 1/2 study of emavusertib after reviewing data submitted by Curis. Company officials say they are working with clinical sites to resume patient enrollment. Curis says the partial clinical hold was lifted following an agreement with the agency
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Replacement Reagent and Instrument Family Policy for In Vitro Diagnostic Devices.” The document addresses a manufacturer’s application for an assay that was previously cleared for use based on performance characteristics when used with a specified instrument to an
FDA Policy/General
Federal Register notice: FDA has announced a 10/6 Vaccines and Related Biological Products Advisory Committee meeting. Panel members are scheduled to discuss the strain selection for influenza virus vaccines for the 2023 southern hemisphere influenza season. To view the notice, click here.
Drugs
FDA has approved an sNDA for Bayer’s Mirena (levonorgestrel-releasing intrauterine system) for extended use as a contraceptive for up to eight years. The device had been approved as a contraceptive for up to seven years, Bayer says. The approval was based on data from the Phase III Mirena
Drugs
FDA has accepted for priority review an Astellas Pharma NDA for fezolinetant, a nonhormonal selective neurokinin 3 receptor antagonist for treating moderate to severe vasomotor symptoms (hot flashes or night sweats) associated with menopause. The submission is based on data from the BRIGHT SKY program, which includes three Phase 3
Devices
FDA has updated a June recall notice to warn healthcare professionals not to use Guangdong Haiou Medical Apparatus Company’s Haiou Needle Retractable Safety 1 mL syringe with 23G 1-inch needle and the Haiou Needle Retractable Safety 1 mL syringe with 25G 1-inch needle due to the potential
Biologics
Covid-19 vaccine makers need to get data on their reformulated booster shots into FDA by the end of the month so they can begin administering them starting in September. But in order to expedite their authorization, FDA is permitting mouse data instead of human data to be submitted, which
FDA Policy/General
Federal Register final rule: FDA is establishing a regulatory category for over-the-counter (OTC) hearing aids and making related amendments to update the regulatory framework for hearing aids. Specifically, it defines OTC hearing aids and establishes applicable requirements; amends existing rules for consistency with the new OTC category; repeals
Devices
FDA says that between 5/1 and 7/31 it has received more than 48,000 medical device reports (MDRs), including 44 reports of deaths, associated with polyester-based polyurethane (PE-PUR) sound abatement foam degradation in certain Philips Respironics ventilators and other medical devices. The agency’s 8/16
Devices
FDA has cleared a Preceptis Medical 510(k) for expanded indications for its Hummingbird Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously cleared in children aged 6-24 months, the new labeling allows in-office procedures in all children six months and older. The company says
Biologics
FDA has approved a bluebird bio BLA for its lentiviral vector gene therapy Zynteglo (betibeglogene autotemcel) (beti-cel) for beta-thalassemia. The agency says Zynteglo is the first cell-based gene therapy for treating adult and pediatric patients with beta-thalassemia who require regular red blood cell transfusions. The inherited
Devices
Attorney Brynn Stanley(Gardner Law) says medical device manufacturers should start planning and implementing the concepts found in an FDA April draft guidance on cybersecurity in both their products and within their quality management system. Writing in an online post, Stanley says that to be effective, cybersecurity needs to be
Biologics
Brainstorm Cell Therapeutics says it will submit a BLA for it NurOwn stem cell therapy for treating amyotrophic lateral sclerosis (ALS and also known as Lou Gehrig’s Disease). Last year, FDA released an unprecedented notice (see story) saying that despite high hopes in the ALS community for NurOwn, Phase
FDA Policy/General
[Report by Jim Dickinson] Amid rising anti-government rhetoric and threats from the far right fanned by supporters of former president Donald Trump, FDA commissioner Robert Califf tells FDA Webview he feels his agency is secure but alert to the menace of disinformation. In an 8/17 discussion with me,
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs).” FDA says hearing aids and PSAPs both affect a user’s ability to hear sound, but the products have different intended uses, and are therefore subject to
Drugs
Cancer researchers from organizations and universities worldwide say their pooled analysis of five independent lung cancer clinical trials demonstrated consistent and robust associations between reductions in circulating tumor DNA (ctDNA) and outcomes. Writing in the open-source journal JSO Precision Oncology, the researchers say “ctDNA may serve as an important
Drugs
Pharmaron says it welcomes an FDA draft guidance on clinical pharmacology considerations for human radiolabeled mass balance studies because it clarifies several topics related to the design, execution, and sample analysis for a human mass balance study that were not previously outlined in this way. The comment also has specific
Drugs
Becton Dickinson says additional clarification is needed in an FDA draft guidance on risk management plans (RMPs) to mitigate the potential for drug shortages. The clarification sought involves which components of a product need to be incorporated into a risk management plan, particularly in the case of device constituent components
Devices
FDA has released a draft guidance entitled “Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations Premarket Notification (510(k)) Submissions.” The document provides labeling recommendations to reduce misuse associated with these devices, which has resulted in serious eye injuries. FDA believes the recommendations may help manufacturers develop labeling