Biologics
FDA has approved a Celltrion BLA for Yuflyma (adalimumab-aaty), biosimilar copy of AbbVie’s Humira. The high-concentration (100mg/mL) and citrate-free formulation is approved for treating eight conditions — rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery.” The agency requests feedback using a variety of methods to gain useful insights into customer or stakeholder perceptions, experiences, and expectations; provide an early warning
Drugs
FDA has published a draft guidance, Generally Accepted Scientific Knowledge in Applications for Drug and Biological Product: Nonclinical Information, describing instances in which it may be appropriate to rely on GASK (generally accepted scientific knowledge) to meet certain nonclinical safety requirements for NDAs and BLAs. The document says the information
Biologics
FDA has extended by three weeks its review of a Sarepta Therapeutics BLA for SRP-9001 (delandistrogene moxeparvovec), an adeno-associated virus vector-based gene therapy product for treating ambulatory patients with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene. The submission is currently under review
Devices
FDA has published a question-and-answer guidance, Use of Whole Slide Imaging in Nonclinical Toxicology Studies, with information for sponsors and nonclinical laboratories on the use and management of whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice(GLP)-compliant nonclinical
Drugs
FDA is asking for comments on factors that should be considered when reviewing modification requests from sponsors of drugs subject to risk evaluation and mitigation strategies (REMS) related to changes in third-party vendors engaged by sponsors to help implement and manage the strategies. A Federal Register notice says that
Drugs
The International Council for Harmonization (ICH) has released for public comment a draft guideline entitled “ICH Harmonized Guideline — Good Clinical Practice (GCP) E6(R3).” The document is intended to provide a unified standard to facilitate mutual acceptance of clinical trial data for ICH member countries and regions by applicable regulatory
Drugs
FDA is soliciting proposals for effective artificial intelligence systems that can assist it with imaging technologies for drug products. The solicitation says potential contractors are asked to submit proposals for non-invasive, high-resolution imaging technologies with artificial intelligence-powered analytics to measure drug performance and develop deeper analyses. Some
Drugs
The Digital Medicine Society (DiMe), dedicated to advancing digital medicine to optimize human health, says it applauds FDA’s commitment to addressing using digital health technologies in drug and biological drug development. Responding to an agency 3/2023 Framework for the Use of Digital Health Technologies in Drug and Biological
Drugs
FDA says it has determined that Champaklal Maganlal Homeo Pharmacy Private Limited in Gujarat, India, is manufacturing, importing, or distributing two unapproved drugs through CAD Import and Pharmadel, both in New Castle, DE. A 5/18 Warning Letter says the firm’s Bebelyn Diarrhea and Bebelyn Colic are particularly concerning
Devices
SD Biosensor has recalled (Class 1) its Pilot Covid-19 At-Home Test due to microbial contamination. “The liquid buffer component in the affected test kit lots was determined to have bacterial contamination,” an FDA recall notice says. “Users may notice a slight odor when the buffer is brought close
Drugs
University of Florida law professor Lars Noah wants FDA to take administrative action to define when client-seeking ads by personal injury lawyers related to FDA-regulated therapeutic products would qualify as potentially misleading lawyer advertising related to drugs and devices. In a 5/19 petition, Noah attaches an article
Drugs
FDA has issued a safety alert on over-the-counter G-Supress DX Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant Cherry Flavor, manufactured by Novis PR LLC, because they may contain the incorrect product and cause patient harm. “Novis received multiple complaints from pharmacies that found the wrong product – Finafta
FDA Policy/General
Federal Register notice: FDA is correcting a 7/13/2022 notice that announced the regulatory review period determination for Genentech’s Enspryng (satralizumab-mwge), indicated for treating neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody positive. The original notice should have stated that the regulatory
Drugs
Aetion chief legal/regulatory officer and former FDA associate commissioner for policy Lowell Schiller says the agency should address the use of external controls and real-world data/evidence (RWD/E) in the context of accelerated approvals, and harmonize its draft guidance on “Clinical Trial Considerations to Support Accelerated Approval
Devices
FDA has granted Orlucent a breakthrough device designation for the company’s Orlucent Skin Fluorescence Imaging System, a handheld point-of-care molecular-based device designed to identify and clinically assess the presence of biological tissue remodeling activity associated with the development of atypical moles in adults. “The Orlucent system
Drugs
The DC District Court has temporarily granted an attorney’s motion to keep his identity secret (see earlier story) in connection with a form FDA-483 that was scheduled to be published. The suit, which lists J. Doe as the attorney, says the agency intended to publish the FDA-483
Drugs
FDA has approved a Braeburn Inc. NDA for Brixadi (buprenorphine) extended-release injection (subcutaneous) for treating moderate to severe opioid use disorder. Brixadi comes in two formulations — a weekly injection for patients who have just started treatment, and a monthly version for patients already being treated with buprenorphine. An FDA
Devices
Abbott reports new data from its AVEIR dual-chamber (DR) i2i Investigational Device Exemption (IDE) study to assess what it describes as the world’s first dual-chamber leadless pacemaker, that met its three prespecified primary endpoints for safety and performance. The data have been submitted to FDA as part
Drugs
Rep. Chip Roy (R-TX) has reintroduced the Reciprocity Ensures Streamlined Use of Lifesaving Treatments" (RESULT) Act that would expedite FDA’s approval process for potentially lifesaving medicines by allowing “reciprocal approval” of drugs approved in other trusted nations. “The American people should not have to wait years and
Drugs
FDA has approved an Entasis Therapeutics NDA for Xacduro (sulbactam and durlobactam for injection), a new treatment for hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. Sulbactam is structurally related to penicillin and durlobactam protects sulbactam from being degraded by
Drugs
FDA has denied a 6/2020 Alliance for Natural Health citizen petition that urged the agency to require all makers of proton pump inhibitors (PPIs) to expand the existing label Warnings to include information about an increased risk of pneumonia. The group’s petition said “the causes of PPI-associated