FDA Policy/General
FDA has released a draft guidance entitled “Human User Safety in New and Abbreviated New Animal Drug Applications.” The agency says that the FD&C Act does not provide specific guidance on data requirements or assessment methods to identify the risks or risk mitigation measures for human users of
Devices
FDA says Abbott has issued a safety notice for the Readers and batteries used as part of the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash glucose monitoring systems. The Readers are small handheld devices that collect real-time glucose readings directly from a sensor worn on
Drugs
OncoSec says the Phase 2 KEYNOTE-695 trial of its Tavo-EP proprietary interleukin 12 encoding plasmid delivered by intratumoral electroporation in combination with Merck’s Keytruda (pembrolizumab) in patients with advanced melanoma refractory to anti-PD-1 treatment failed to meet its primary endpoint of overall response rate. A
Devices
A 10/11-10/26/22 FDA inspection at Synovo Production in Fullerton, CA, determined that the firm is the specification developer, manufacturer, and distributor of a femoral resurfacing cup that is distributed as a standalone product and as part of a total hip system. A 3/23 Warning Letter
Drugs
Lilly researchers who evaluated an FDA 2012 program to promote greater transparency and increased communication between the agency and applicants of new molecular entity (NME) NDAs and original BLAs say the agency was consistent in meeting the program goals. Writing in Therapeutic Innovation & Regulatory Science, the researchers say they
Drugs
FDA has approved an emergency use authorization (EUA) to use InflaRx’s Gohibic (vilobelimab) injection to treat Covid-19 in hospitalized adults when initiated within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation. An agency statement says the treatment targets a part of the immune system that
Drugs
FDA researchers are looking at the possibility of speeding biosimilar development through a streamlined approach in which pharmacokinetic (PK) and pharmacodynamic (PD) similarity data are submitted with comparative safety and immunogenicity data. An agency notice says investigators can collect PK and PD data from shorter, less costly studies, often enrolling
FDA Policy/General
Federal Register notice: FDA has established a docket to obtain information and comments to help assess whether in-home disposal products can be expected to meet the public health goal of mitigating the risk of nonmedical use or overdose if the agency were to require drug manufacturers to make in-
Drugs
CBER director Peter Marks says the agency will decide in June what the fall Covid-19 vaccine composition should look like, adding that firms need to focus on broadening the protection of their annual booster vaccines to help public uptake of future annual shots. Speaking at the World Vaccine Congress
Drugs
Phathom Pharmaceuticals says it will resubmit by the end of June an NDA for vonoprazan for treating erosive esophagitis, and a post-approval supplement for Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin). In February, FDA sent two complete response letters related to the submissions that
Drugs
FDA has accepted for review two Pfizer Supplemental NDAs for Braftovi (encorafenib) and Mektovi (binimetinib) and their use in patients with metastatic non-small cell lung cancer with a BRAF V600E mutation, as detected by an FDA-approved test. The agency has set a user fee review action target date
Drugs
A JAMA research letter says 54% of the 177 accelerated approval-related confirmatory studies conducted between 2012 and 2021 were late in meeting their FDA completion deadlines. “Trials for nononcologic indications (93% [15 of 16]) were more likely to be late than those for oncologic indications (46% [39 of 84]
Drugs
FDA has approved an Astellas Pharma BLA for Padcev (enfortumab vedotin-ejfv) for use with Merck’s Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy. Approval was based on data from the EV-103/KEYNOTE-869 study. The confirmed
Drugs
FDA has cleared a BC3 Technologies 510(k) for its SEAL Hemostatic Wound Spray, described as an aerosolized chitosan for rapidly addressing serious arterial bleeding. “When sprayed on a bleeding wound, SEAL quickly forms a strong barrier that helps stop bleeding within seconds and without pain,” the company says. “SEAL
Drugs
FDA says it is requiring opioid analgesic manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional disposal option for patients. “Expanding impactful opioid disposal options, such as mail-back envelopes and in-home disposal, for patients to safely and securely dispose of
Drugs
CBER’s Office of Compliance and Biologics Quality has issued an untitled letter to Minneapolis Regenerative Medicine, objecting to claims and statements made on the firm’s Web site and marketing materials. The letter says the cellular product is marketed for treating various diseases or conditions, such as osteoarthritis and
Devices
FDA has granted a de novo marketing authorization to Happiest Baby for its SNOO, a medical device for keeping sleeping babies safely on their backs. “The SNOO Smart Sleeper bassinet plus the SNOO Sleep Sack are jointly intended to facilitate a supine position during sleep,” the company says. Infants who
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Infectious Otitis Externa Drugs for Topical Use in Dogs.” The document provides recommendations to help sponsors complete the effectiveness, target animal safety, and labeling technical sections of a new animal drug application for such products. To view the notice,
Drugs
FDA has told Ascendis Pharma that deficiencies identified in the company’s NDA for TransCon PTH (palopegteriparatide), indicated for treating hypoparathyroidism, prevents the agency from holding further discussions about labeling and post-marketing requirements/commitments. While not disclosing any specifics, an agency letter said that its position does not currently
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions.” The document describes a least burdensome approach that would support iterative improvement through modifications to machine learning-enabled device
Drugs
A recent inspection of Global Pharma Healthcare in Tamilnadu, India has led to a just-posted 14-page FDA Form-483 that cites significant GMP deficiencies. For example, the form says the company’s procedures for preventing microbiological contamination were inadequate because they did not include validation of the sterilization
Drugs
Senators Tina Smith (D-MN) and Mike Braun (R-IN) have reintroduced bipartisan legislation that would prevent pharmaceutical company actions to block generic drug competition through a practice called “parking.” The senators say that parking occurs when a brand company agrees not to sue the first company that submits an