Devices
In a 6/3 letter to healthcare providers, FDA says Medtronic is no longer selling and distributing its Heartware Ventricular Assist Device (HVAD) system. The letter says Medtronic determined: * there is an increased risk of neurological adverse events and mortality associated with the internal pump; and * there is potential for
Drugs
FDA has posted a draft guidance entitled Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations. The document covers in vitro testing recommendations to ensure oral drug product quality and bioequivalence to a reference-listed drug when evaluating a drug product’s suitability for administration
Drugs
FDA has accepted for review a Liquidia NDA resubmission for LIQ861 (treprostinil) inhalation powder to treat pulmonary arterial hypertension (PAH). The agency has confirmed that the resubmission was a complete, Class 2 response to a 11/24/2020 complete response letter and has set a user fee review action target
Biologics
The Pew Charitable Trusts says FDA needs to maintain pressure on businesses offering unapproved stem cell and regenerative medicine interventions (SCRIs) and ensure that patients are protected from SCRIs that have caused harm or have the potential to cause harm. Pew says it gathered reports of adverse events linked to
Drugs
The Massachusetts federal court has granted a renewed motion for summary judgment submitted by GlaxoSmithKline to dismiss multi-district litigation alleging that the company failed to provide sufficient warning that the use of Zofran (ondansetron) by pregnant women caused birth defects in their children. The court held that state failure-
Devices
CDRH says its Accreditation Scheme for Conformity Assessment (ASCA) pilot program is on schedule, with 53 test labs having been granted ASCA accreditation. ASCA team member Angela DeMarco told a 5/20 Webinar “the ASCA pilot is in full swing now that test labs have been accredited and review staff
Devices
FDA has granted a de novo marketing authorization request to Cognoa for its Cognoa ASD Diagnosis Aid to help diagnose autism spectrum disorder (ASD). The machine learning-based software is intended to help health care providers diagnose ASD in children 18 months through five years of age who exhibit potential
Devices
A follow-up study of 16,320 patients with atrial fibrillation (AF) found increased use of follow-up healthcare for those who use smartwatches or other wearable devices, compared with those with similar pulse rates who do not use wearables. The open-access study was conducted by researchers from several
Devices
FDA says it is aware of sterility issues with medical devices processed at the Steri Milano SRL Reggiolo and Monza ethylene oxide sterilization facilities in Italy. “FDA became aware that Steril Milano falsified graphs and parameters of sterilization certificates for a variety of FDA regulated products, dating back to 2016,
Drugs
FDA has approved a Scynexis NDA for Brexafemme (ibrexafungerp) tablets for oral use in patients with vulvovaginal candidiasis (vaginal yeast infection). The company says it is the first approved drug in a novel antifungal class in more than 20 years. Approval was based on data from two Phase 3 studies
Drugs
The Council for Responsible Nutrition (CRN) has petitioned FDA to reverse its recent position that the Federal Food, Drug, and Cosmetic Act prohibits manufacturers from marketing products containing N-acetyl-L-cysteine (NAC) as dietary supplements. “The policy, which represents a sudden and drastic departure from past agency practice, is
Biologics
FDA acting commissioner Janet Woodcock says the once-fledgling biosimilar industry is becoming more mature following the introduction of the agency’s Biosimilar Product Development (BPD) Program three years ago. As of 5/1, 94 programs are enrolled in the BPD Program, she told the Association for Accessible Medicines annual
Biologics
A 2/1-2/11 FDA inspection at Utah Cord Bank, Sandy, UT, documented significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products (HCT/Ps). A 5/11 Warning Letter says specific deviations were: * failing to validate and approve a process according to established
Drugs
The FDA Oncology Center of Excellence (OCE) has opened a “Send Your Oncology Research Questions to FDA” crowdsourcing challenge to allow interested stakeholders to submit directly to FDA staff their ideas for research using pooled analyses of oncologic clinical trial data. An online notice says agency scientists traditionally have used
Drugs
FDA has extended by three months its review of Verrica Pharmaceuticals’ NDA for VP-102 (cantharidin) for treating molluscum contagiosum, a common, highly contagious skin disease The review extension is intended to give FDA additional time to review information (major amendment) recently submitted by Verrica, including a training program and
Devices
A 2/17-2/26 FDA inspection at the DeChoker medical device operation in Wheat Ridge, CO, determined that the firm manufactures the DeChoker tracheobronchial suction device. A 5/10 Warning Letter says the device is adulterated because it does not conform to the current good manufacturing practice requirements of
FDA Policy/General
Federal Register notice: FDA has determined that Novartis’ Sandostatin (octreotide acetate) injection (0.2 mg base/ml) and 1 mg base/mL) was not withdrawn for safety or effectiveness reasons. The determination means that FDA can continue to approve ANDAs that reference the product as long as they meet relevant
Drugs
FDA has issued a safety communication that warns against using Lepu Medical Technology SARS-CoV-2 Antigen Rapid Test Kit and the Leccurate SARS-CoV-2 Antibody Rapid Test Kit (Colloidal Gold Immunochromatography). “The FDA has serious concerns about the performance of the SARS-CoV-2 Antigen Rapid Test Kit
Devices
Greenlight Guru founder Jon Speer says medical device companies need closed-loop traceability (CLT) to demonstrate identification and traceability in all quality system processes and thus comply with FDA regulations. Writing in an online Quality Digest column, Speer says that with a global regulatory emphasis on CLT, it’s up
Drugs
The FDA Oncology Center of Excellence (OCE) is holding its first National Black Family Cancer Awareness Week from 6/17-6/23. “Throughout the week, the agency’s social media platforms will serve as the hub for this historic initiative as participants at healthcare centers, non-profit associations, and community
Drugs
HHS is asking the DC federal court to dismiss an 11/2020 suit filed by Pharmaceutical Research and Manufacturers of America, the Partnership for Safe Medicines, and the Council for Affordable Health Coverage that asked the court to block the Trump administration HHS and FDA from implementing a program to
Biologics
Moderna has begun a rolling BLA for its mRNA Covid-19 vaccine for use in individuals 18 years of age and older. The company says it will continue to submit data to support the BLA over the coming weeks, leading to a priority review once the submission is completed. To