Drugs
FDA has released the form FDA-483 issued following an 8/16-8/26 inspection at the Cipla drug manufacturing facility in Goa, India. The five inspection observations were: * aseptic processing areas are deficient regarding the system for monitoring environmental conditions; * procedures designed to prevent microbiological contamination of drug products
Devices
The HHS Office of Inspector General (OIG) says there are lessons to be learned from the way FDA approached Emergency Use Authorization (EUA) policies for Covid-19 testing. The OIG says that to develop its report, it relied on FDA documents, data, and interviews to determine how the agency conducted
Drugs
FDA has approved Fennec Pharmaceuticals’ Pedmark (sodium thiosulfate) to reduce the risk of ototoxicity associated with cisplatin in pediatric patients one month and older with localized non-metastatic solid tumors. An agency notice says the drug’s efficacy was evaluated in two multi-center open-label trials in pediatric patients
FDA Policy/General
Federal Register notice: FDA has announced an 11/22 Oncologic Drugs Advisory Committee meeting to discuss a GlaxoSmithKline supplemental NDA for Zejula (niraparib) capsules. Panel members will discuss the drug’s use for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who
Drugs
FDA has approved a Guerbet NDA for Elucirem (gadopiclenol), a new macrocyclic gadolinium-based contrast agent (GBCA) for use in contrast-enhanced magnetic resonance imaging (MRI). The product is used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the
Biologics
FDA has issued contract manufacturer Catalent a 12-item Form FDA-483 over GMP concerns found during a recent inspection at the firm’s Bloomington, IN facility that performs fill operations on Moderna’s Covid-19 Bivalent booster vaccine. The inspection concluded 9/2 and it is intended to add
Devices
FDA has cleared a Medtronic 510(k) for its LINQ II Insertable Cardiac Monitor (ICM) system for expanded use in pediatric patients over the age of two years who have heart rhythm abnormalities and require long-term, continuous monitoring. The tiny implantable device (one-third the size of a AAA
Drugs
FDA has lifted a 12/2021-ordered clinical hold on a Merck IND to permit a new Phase 3 clinical program with once-daily islatravir for treating people with HIV-1 infection. The studies will evaluate a once-daily oral combination of doravirine 100 mg and a lower dose of
Drugs
FDA is stepping up its drug inspections in India and plans to have more short-notice inspections, according to the Economic Times. The newspaper says it was informed by FDA country director for India Sarah McMullen that the agency is nearing pre-pandemic levels in terms of inspection activity.
Drugs
FDA is planning to release in the coming months a draft guidance on “Incorporating Clinical Outcome Assessments into Endpoints for Regulatory Decision Making.” Speaking during an online 9/16 Alliance for a Stronger FDA program, CDER associate director for strategic initiatives Theresa Mullin said this was the last in a
FDA Policy/General
Harvard Medical School researchers say the federal government “has not exercised the full scope of its authority to prosecute corporate officials responsible for the illegal behavior of the drug and device companies they run.” Writing in JAMA Internal Medicine, the researchers say enforcement under a reinvigorated Responsible Corporate Officer doctrine
Drugs
An 8/23-9/3/21 FDA inspection at BioLab Sciences, Scottsdale, AZ, found the company manufactures products derived from human amniotic fluid for allogenic use and an epidermal skin tissue product for autologous use. An 8/23 Warning Letter says BioLab has distributed the products to third-party distributors,
Drugs
FDA medical reviewers have raised significant questions in advance of a 9/22 meeting of the agency’s Oncologic Drugs Advisory Committee to consider Spectrum Pharmaceuticals’ application for accelerated approval of Pozenveo (poziotinib) to treat patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring human
Drugs
FDA reviewers say that a confirmatory trial has not confirmed the clinical benefit of Oncopeptides’ Pepaxto (melphalan flufenamide), which could jeopardize the continued marketing of the 2021 accelerated-approved drug for use in treating certain patients with relapsed or refractory multiple myeloma (RRMM). The agency’s Oncologic Drug Advisory Committee
Drugs
The Alliance for Regenerative Medicine (ARM) says it appreciates the FDA targeted draft guidance on real-time oncology review (RTOR). The ARM comment letter makes suggestions in terms of eligibility and application of RTOR at CBER and for cell and gene therapy, alignment with the Oncology Center of Excellence RTOR
Drugs
FDA and the other regulatory agencies that are members of the Generic Drug Cluster have spent their inaugural year in meetings in which they collaborated on several regulatory topics. In an online CDER Conversation, Office of Generic Drugs (OGD) associate director for global generic drug affairs Sarah Ibrahim says many
Devices
FDA has issued a safety alert on a cybersecurity risk with Medtronic’s MiniMed 600 Series Insulin Pump System (e.g., MiniMed 630G and MiniMed 670G). “There is a potential issue associated with the communication protocol for the pump system that could allow unauthorized access to the pump system,” the
FDA Policy/General
Federal Register notice: FDA is requesting patient advocate applications for participation under its collaboration with the Clinical Trials Transformation Initiative’s Patient Engagement Collaborative (PEC). The PEC is an ongoing forum where the patient community and regulators are able to discuss an array of topics on increasing meaningful patient engagement
FDA Policy/General
Federal Register notice: FDA has determined that Hoffmann-La Roche’s Endep (amitriptyline HCl) oral concentrate, 40 mg/mL was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to approve ANDAs referencing the product if all legal and regulatory requirements are met. To view
Devices
Roche has received FDA 510(k) clearance for the cobas pure integrated solutions, the next generation of its cobas diagnostics platform. The device combines three technologies — clinical chemistry, immunoassay and ion-selective electrode diagnostic testing — on a single platform. Cobus pure focuses on automating manual tasks to reduce the “hands-
Devices
FDA has cleared a ClearPoint Neuro 510(k) for its version 2.1 of the ClearPoint Neuro Navigation software. The software provides stereotactic guidance for placing and operating instruments or devices during planning and operation of neurological procedures using MRI scanners (biopsies, catheter and electrode insertion, including deep brain stimulation
Drugs
Companies that market drugs for off-label uses need not only worry about running afoul of FDA but also shareholders who learn about such practices and decide to sue when such public information causes their stock to lose value. An Eastern New York federal judge has preliminarily approved an $11.