Drugs
An FDA inspection conducted 4/15-4/23 at Zydus Lifesciences’ injectable manufacturing site in Jarod, India resulted in a 10-observation Form FDA-483, according to a company financial release. “The company will closely work with the U.S. FDA to address and respond to the observations in an
Drugs
Three Alston Bird attorneys say there are several steps companies regulated by FDA should take to engage with the agency on its artificial intelligence/machine learning (AI/ML) regulatory activities. Writing in their firm’s FDA/Food, Drug, & Device Advisory, the three say companies should: * review and comment on
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 23 NDAs from multiple applicants after they notified the agency that the drugs are no longer marketed and requested that they be withdrawn. To view the notice, click here.
Devices
CDRH says it is launching a Home as a Healthcare Hub initiative “to help reimagine the home environment as an integral part of the healthcare system, with the goal of advancing health equity for all people in the U.S.” An announcement says the Center has contracted with an architectural
Drugs
FDA has approved an ImmunityBio BLA for Anktiva (nogapendekin alfa inbakicept-pmln) plus Bacillus Calmette-Guérin (BCG) for treating patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ, with or without papillary tumors. The therapy stimulates memory T cells, “leading to long duration of complete response
Devices
FDA has cleared a Sail Fusion 510(k) for its BowTie Sacroiliac Fusion System. The device features a novel bowtie shape as well as integrated transfixation and iliac screws to maximize rigidity, the company says. “It also utilizes a proprietary porous structure and roughened surface technology to facilitate osteointegration,” it
FDA Policy/General
FDA has granted Day One Biopharmaceuticals accelerated approval for Ojemda (tovorafenib), a Type 2 RAF inhibitor for treating patients six months of age and older with relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG), the most common form of childhood brain tumors. “BRAF is the most commonly altered
Devices
A 10/23-10/26/2023 FDA inspection at the Royal Philips facility in Suzhou, China, found Quality System Regulation and Medical Device Reporting violations in the firm’s manufacturing of computed tomography and ultrasonography systems. A just-released 2/23 Warning Letter says the firm’s products are adulterated
FDA Policy/General
Federal Register notice: FDA making available its annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments” for fiscal year 2022. The agency is required to report annually on the status of postmarketing requirements and postmarketing commitments required of, or agreed upon
FDA Policy/General
Federal Register notice: FDA’s Medical Devices Advisory Committee’s Molecular and Clinical Genetics Panel announces a 5/23 meeting to review a Guardant Health PMA for its Shield blood test for colorectal cancer (CRC) screening. The proposed indication for use statement is as follows: “The Shield test is a
Drugs
FDA says that applicants completed or released most of the postmarketing reports/postmarketing commitments (PMRs/PMCs) for the previous years reported on in the agency’s FY 2022 report on PMR/PMC status. The majority of PMRs/PMCs are progressing according to the original schedule, it says, and overall few
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Data To Support Social and Behavioral Research as Used by the Food and Drug Administration.” The collection supports agency-conducted research for understanding patients, consumers, and healthcare professionals’ perceptions and behaviors to improve FDA’s regulatory decision-
Drugs
Endo’s Par Pharmaceutical is recalling seven lots of treprostinil injection 20g/20mL due to the potential for the presence of silicone particulates in the product solution. “Administration of an injectable product that contains particulate matter may result in local irritation or swelling in response to the foreign material,” a
Devices
Exactech has recalled its Equinoxe Shoulder System devices packaged in defective bags from facilities’ unused inventory. Earlier this year, FDA alerted patients and healthcare providers about the joint replacement devices and possible health risks. The devices were manufactured between 2004 and 2021, the agency said at the time. “The defective
Devices
FDA is warning against the use of over-the-counter anti-choking devices because their safety and effectiveness have not been established, and they are not approved or cleared by the agency. “Consumers should be aware that using anti-choking devices first could delay action, as consumers usually have to
Devices
FDA has cleared a Royal Philips 510(k) for its Philips Zenition 30 mobile C-arm imaging device. The company says the device features greater C-arm flexibility, control, and personalization that reduces dependency on technician support. “Advanced imaging algorithms contribute to outstanding image quality for procedure confidence, coupled with
Devices
FDA’s Medical Devices Advisory Committee’s Molecular and Clinical Genetics Panel is scheduled to review a Guardant Health PMA for its Shield blood test for colorectal cancer (CRC) screening on 5/23. The expert panel will discuss the clinical data from the company’s ECLIPSE study and the potential
Biologics
FDA has issued Abeona Therapeutics a complete response letter (CRL) on a a BLA for prademagene zamikeracel (pz-cel), requesting additional information to satisfy chemistry manufacturing and controls (CMC) requirements before the submission can be approved. The submission seeks the therapy’s approval for use in treating patients with recessive
Devices
Draeger Medical has recalled (Class 1) its Draeger Perseus A500 Anesthesia Workstation due to the potential for an unexpected shutdown while operating on battery power. Last month, the company sent consignees an urgent medical device recall notification about the problem and the possible loss of ventilation if a shutdown occurred,
Drugs
FDA has ordered a Boxed Warning to highlight the serious risk of T cell malignancies following administration of BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T-cell immunotherapies. The increased warning follows a 11/2023-posted safety communication about reports of T cell malignancies received from
Devices
FDA has cleared a Cochlear 510(k) to lower the patient age for its Cochlear Osia System from 12 years to five years for children with conductive hearing loss, mixed hearing loss and single-sided sensorineural deafness. The bone conduction hearing device uses digital piezoelectric stimulation to bypass damaged areas
Biologics
FDA has approved Alvotech and Teva Pharmaceuticals’ Selarsdi (ustekinumab-aekn) injection for subcutaneous use, a biosimilar to Johnson & Johnson’s Stelara, for treating moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six years and older. “Being able to develop the biosimilar in