Drugs
FDA has approved Merck’s Dificid (fidaxomicin) oral suspension and tablets for treating Clostridium (also known as Clostridioides) difficile infections in children aged six months or older. The macrolide antibacterial was previously indicated in adults for treating Clostridium difficile-associated diarrhea. Difficile is a bacterium that causes diarrhea and colitis,
Devices
FDA has released a draft guidance on “Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions” that provides recommendations for device design considerations, risk mitigation strategies, and testing recommendations. The devices are designed to deliver irrigation fluid to surgical sites (knee, shoulder, hip, etc.) during
Devices
FDA has launched a new Web page to help companies advance development of novel coronavirus medical countermeasures. Faced with growing concern about the spreading virus, the agency says it will “collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products
FDA Policy/General
Federal Register notice: FDA has made available two final guidances entitled “Clinical Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions” and “In Vitro Drug Interaction Studies — Cytochrome P450 Enzyme- and Transporter-Mediated Drug Interactions.” The guidances are intended to assist drug developers in evaluating drug-drug interaction
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher for the approval of a rare pediatric disease product application — Sarepta Therapeutics’ Vyondys 53 (golodirsen) for treating Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. To view
FDA Policy/General
Federal Register notice: FDA has made available a revised draft guidance entitled “Draft Guidance for Levonorgestrel.” The document provides product-specific recommendations on bioequivalence studies to support ANDAs for a levonorgestrel intrauterine device. To view the notice, click here.
Drugs
FDA has released a final guidance on “Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment.” The document is intended to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials or to support drug
FDA Policy/General
Federal Register notice: FDA has announced a 2/26 Oncologic Drugs Advisory Committee meeting. During the morning session, the panel will discuss a Steba Biotech NDA for padeliporfin di-potassium powder for solution for treating patients with localized prostate cancer. In the afternoon, they will discuss an Eli Lilly supplemental
Drugs
FDA is seeking outside groups or individual data scientists for the development of computational algorithms to identify adverse event anomalies in open FDA adverse event data available on its openFDA platform. “Automated adverse event anomaly detection would augment the traditional data mining and case review approach by enabling the unsupervised
Drugs
FDA has granted accelerated approval for Epizyme’s Tazverik (tazemetostat) for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Approval was based on data from a single-arm cohort (Cohort 5) of a multi-center trial (Study
Devices
FDA has approved an expanded indication for Abbott’s Infinity Deep Brain Stimulation (DBS) system to include targeting of an area of the brain called the internal globus pallidus (GPi). The company says the GPi plays an important role in motor function and can be targeted with DBS to improve
Drugs
A Genentech Phase 3 study (IMvigor010) evaluating Tecentriq (atezolizumab) in people with muscle-invasive bladder (urothelial) cancer did not meet its primary endpoint of disease-free survival. The company says more treatment options are needed after surgery because about half of patients will see disease recurrence within two years after
Devices
King Systems has recalled 171 units of its King Vision Video Laryngoscope (adapter size 1/2) because they may display a reversed image, which could potentially result in difficulty navigating during intubation or delay intubation. Affected device images may appear normal, but user’s actions will be reversed on the
Drugs
FDA has published two guidances dealing with drug-drug interactions. The first guidance, In Vitro Drug Interaction Studies—Cytochrome P450 Enzyme- and Transported-Mediated Drug Interaction, is to help drug developers plan and evaluate studies to determine the drug-drug interaction (DDI) potential of an investigational drug product. The document
Drugs
AbbVie says it expects FDA to make a decision before summer on a new indication for its Orilissa (elagolix) to treat uterine fibroids in premenopausal women. The Philadelphia Inquirer reports the agency is considering results from two clinical trials conducted at 77 sites in the U.S. and Canada in
FDA Policy/General
ABH Nature's Products, ABH Pharma and Stocknutra.com is conducting a nationwide recall of its dietary supplement products manufactured and sold between 1/2013 to 11/2019. The products are being recalled after an FDA inspection found significant GMP violations, according to a recall notice. To date, it
Devices
FDA has cleared a Baze 510(k) for its at-home blood collection process. The testing kit is intended to assess blood nutrient status, which Baze analyzes to offer nutrition plans and supplement subscriptions curated for individual customers, the company says. It uses the company’s Nutrition Information System to
Devices
FDA has given Medtronic approval to proceed with an IDE trial (PULSED AF) to evaluate the safety and effectiveness of the PulseSelect Pulsed Field Ablation (PFA) System, a new technology that uses pulsed electric fields to treat atrial fibrillation. The company says that PFA uses pulsed electric fields to ablate
Devices
Wisconsin cardiologist Nalini Rajamannan, medical director of the Most Sacred Heart of Jesus Cardiology and Vascular Institute, has sent FDA commissioner Stephen Hahn an affidavit arising from her years of effort to get the agency to release information to 667 patients who were implanted with the Edward Lifesciences Myxo ETlogix
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Reporting Associated With Animal Drug and Animal Generic Drug User Fees” (OMB Control Numbers 0910-0540). The information is used by CVM to initiate the administrative screening of new animal drug applications and supplements. To view the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Electronic Products — 21 CFR Parts 1000 Through 1050” (OMB Control Number 0910-0025). FDA has the authority to establish and carry out an electronic product radiation control program, including the development, issuance, and administration of performance standards
FDA Policy/General
Federal Register notice: FDA has determined that Chiesi USA’s Cardene (nicardipine hydrochloride) injection, 25 mg/10 ml, was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs for nicardipine hydrochloride injection if all other legal and regulatory requirements are met. Cardene