Drugs
Lilly is suing FDA in an Indiana federal court to overturn the agency’s decision that the company’s investigational product retatrutide is a drug and not a biologic. It is one of the first suits to take advantage of the Supreme Court’s decision to scrap the decades-old
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for GlaxoSmithKline’s Ojjaara (momelotinib), indicated for treating intermediate or high-risk myelofibrosis in adults with anemia. The regulatory review period is 5,127 days, of which 4,670 days occurred during the testing phase and
Drugs
Responding to an FDA draft guidance on questions and answers about post-approval manufacturing changes to biosimilar and interchangeable biosimilar products, Samsung Bopepis questions the need for an additional guidance since all biologics should be treated the same. “Regulatory consistency and the application of the same regulatory science by regulators
Drugs
The U.S. House of Representatives 9/23 passed the Give Kids a Chance Act (HR 3433) that is intended to address childhood cancer and rare diseases. The bill was introduced by Reps. Michael McCaul (R-TX) and Anna Eshoo (D-CA). According to an Eshoo news release, the measure
Drugs
FDA has just released the form FDA-483 issued following a 10/23-10/27/2023 inspection at the Eisai drug manufacturing facility in Gifu, Japan. The two observations were: * failure to maintain in writing and fully follow the responsibilities and procedures applicable to the quality control unit; and * failure
Drugs
FDA has accepted for review an Arcutis Biotherapeutics supplemental NDA for Zoryve (roflumilast) foam 0.3%, a once-daily, next-generation phosphodiesterase-4 (PDE4) inhibitor for treating adults and adolescents ages 12 and over with scalp and body psoriasis. The agency has set a user fee review action target date
Drugs
FDA has just released the form FDA-483 issued following a 2/27-3/16/2023 inspection at the Hugel drug substance and product manufacturing facility in Gangwon-do, Republic of Korea. The five specific inspection observations were: * failure to have an established cleaning and disinfection program to prevent the
Devices
FDA has cleared a B. Braun Medical 510(k) for the Introcan Safety 2 Deep Access IV Catheter, the newest addition to the company’s Introcan portfolio. The device provides automatic passive safety needlestick protection and multi-access blood control in longer lengths than its earlier version of the device,
Drugs
A 2/2-3/2/23 FDA inspection at the Azurity Pharmaceuticals drug manufacturing facility in Wilmington, MA, found that the firm manufactures several prescription drug products referred to as FIRST Unit-of-Use kits that are legally considered to be unapproved new drugs. A 9/20 Warning Letter says
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Idorsia Pharmaceuticals’ Quviviq (daridorexant hydrochloride), indicated for treating adult patients with insomnia characterized by difficulties with sleep onset or sleep maintenance. The regulatory review period is 2,115 days, of which 1,660 days occurred
Drugs
The FDA Oncology Drugs Advisory Committee meets 9/26 to discuss the risk/benefit assessment of using immune checkpoint inhibitors (ICIs) with chemotherapy for the first-line treatment of patients with (1) unresectable or metastatic esophageal squamous cell carcinoma at different levels of programmed death ligand 1 (PD-L1) protein
Drugs
A 2023 inspection at C&T Dream Co. (Cheonan, Korea) resulted in a nine-observation FDA Form-483 that cites significant GMP deviations. For example, the FDA investigator said the laboratory records are deficient in that they do not include a complete record of all data obtained during testing.
Drugs
Gilead Sciences has recalled one lot of Veklury (remdesivir) for injection 100 mg/vial, after it received a customer complaint and confirmed the presence of a glass particle in the product’s vial. “The administration of an injectable product that contains glass particles may result in local irritation or swelling
Devices
FDA has appointed former Olympus Medical Systems chief medical officer Ross Segan as CDRH Office of Product Evaluation and Quality director, replacing William Maisel who retired earlier this year and is now senior medical officer at robotics company Intuitive Surgical. During his time at Olympus, Segan likely dealt with significant
Drugs
Ideaya Biosciences says it is advancing darovasertib, an investigational therapy for neoadjuvant uveal melanoma (UM), into a Phase 3 trial following “positive interim” Phase 2 clinical trial data and a successful FDA Type C meeting on the registrational trial design for seeking regulatory approval. “Darovasertib has demonstrated compelling preliminary clinical
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of four NDAs from multiple sponsors because they repeatedly failed to file required annual reports. The NDA holders also failed to respond to agency notices offering an opportunity for a hearing. To view the notice, click here.
Devices
[Analysis by Jim Dickinson] Physician-attorney Jeff Shuren is gone from CDRH but his hand-picked interim successor, deputy director Michelle Tarver, continues his cozy-with-industry corruption of FDA’s patient safety mission at the Center. A troubling part of their legacy is the broken lives of patients devastated
FDA Policy/General
Federal Register notice: FDA is making available three draft guidances for its Accreditation Scheme for Conformity Assessment Program. They are entitled “The Accreditation Scheme for Conformity Assessment Program” “Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment — Standards Specific Information for the Accreditation
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Chemical Analysis for Biocompatibility Assessment of Medical Devices” that recommends methodological approaches for chemical analysis for devce biocompatibility assessments. To view the notice, click here.
Drugs
FDA has approved UCB’s Bimzelx (bimekizumab-bkzx) for treating adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). The therapy is designed to selectively inhibit two key cytokines driving inflammatory processes
Drugs
FDA has approved Zevra Therapeutics’ Miplyffa (arimoclomol) for treating Niemann-Pick disease, Type C (NPC) in adults and children aged two and older. The rare genetic disorder is characterized by progressive neurological deterioration and organ dysfunction, an agency release says. The disease is caused by changes in either the NPC1
FDA Policy/General
Federal Register notice: FDA is announcing year three of its Chemistry, Manufacturing, and Controls (CMC) Development and Readiness Pilot. FDA designed the pilot program to assist with CMC readiness for CDER- and CBER-regulated products that have accelerated clinical development timelines. It features increased communication between the agency and sponsors