FDA Policy/General
BIOLOGICS FDA has approved a Janssen Biotech BLA for Stelara (ustekinumab) for treating moderately to severely active Crohn’s disease in adults (18 years or older) who have failed or were intolerant to treatment with immunomodulators or corticosteroids but never failed treatment with a tumor necrosis factor blocker, or who
FDA Policy/General
Millenium Health says it has won a contract worth a potential $1.6 million to provide FDA with urine drug tests for a trial that will assess the development of opioid tolerance in patients taking pain medication with an abuse deterrent formula. The company adds that it has recently agreed
Drugs
FDA has granted ASC Therapeutics a fast track designation for ASC618, a second-generation gene therapy for treating hemophilia A patients. The company received an IND approval in 2021 and an Orphan Drug Designation in 2020 for the therapy. The company describes ASC618 as an AAV8-based gene that “incorporates
Drugs
FDA has extended by three months its review of a Merck supplemental BLA for Vaxneuvance (pneumococcal 15-valent conjugate vaccine) in infants and children. The agency extension provides more time for it to review requested additional analyses of data from Merck’ pediatric studies. The company notes no new studies have
Biologics
Y-mAbs Therapeutics has re-submitted a BLA for omburtamab to treat patients with CNS/leptomeningeal metastases from neuroblastoma after what it characterizes as a positive pre-BLA meeting with FDA reviewers. In 10/2020, FDA issued a refuse-to-file letter on the therapy due to deficiencies with the
Drugs
FDA says that it is now issuing electronic Certificates of Pharmaceutical Product (eCPPs) that also include a unique Quick Response (QR) code to permit quicker verification of the authenticity of eCPPs. “Anyone, including foreign governments, that receives an eCPP for human drug products exported from the U.S. FDA may
Drugs
While FDA continues to sift through public comments it requested (see earlier story) about how to comply with a court decision and move certain contrast agents from being regulated as drugs to devices, a new “legal insight” post sees Congress eventually stepping in to clarify that all contrast agents remain
Drugs
FDA says that it is considering exercising enforcement discretion for N-acetyl-L-cysteine (NAC)-containing products labeled as dietary supplements. But for the time being, the agency says it is still reviewing the issue and it denied two citizen petitions from the Council for Responsible Nutrition and the Natural
Devices
FDA has approved a CartiHeal PMA for its Agili-C implant, indicated for treating an International Cartilage Repair Society (ICRS) Grade III or above knee-joint surface lesion with a total treatable area of 1-7cm2 and without severe osteoarthritis. Approval was based on data from a two-year IDE
Drugs
A legislative proposal distributed as part of FDA’s budget request documents intends to “amend the 180-day exclusivity provisions to encourage timely marketing of first generics.” However, attorney Kurt Karst (Hyman, Phelps & McNamara) writes in his firm’s FDA Law Blog, the result would be the opposite of
Drugs
FDA says it has been working on a project to identify and prioritize pharmaceutical quality/chemistry, manufacturing, and controls (PQ/CMC) information that would benefit from a structured submission approach. “This structured and standardized information is intended to be submitted in Module 3 of the Common Technical Document as defined
Devices
FDA has approved Edwards Lifesciences’ Mitris Resilia valve, a tissue valve replacement specifically designed for the heart’s mitral position. The company says the valve has a “saddle-shaped sewing cuff that mimics the asymmetric shape of the native mitral valve. It also features a low-profile frame that helps
Devices
FDA says Magellan Diagnostics has resumed distribution of its LeadCare II product that was previously unavailable. The LeadCare Plus and LeadCare Ultra products are currently unavailable, an agency update says. FDA announced on 5/28/21 a Class I Magellan recall of its LeadCare II, LeadCare Plus, and LeadCare Ultra
Biologics
FDA has issued an immediately effective update to its 5/2021 guidance Emergency Use Authorization for Vaccines to Prevent Covid-19. The document provides the agency’s current thinking on the data and information needed to support the issuance of an emergency use authorization for an investigational vaccine to prevent
Drugs
Fewer FDA inspections over the past two years have also resulted in fewer data integrity citations at drug manufacturing facilities, but the agency doesn’t think for a moment that industry has rid itself of such concerns. FDA is prioritizing inspections of firms with the highest risk of finding compliance
Drugs
Lupin Pharmaceuticals, a manufacturer of branded and generic drugs, says FDA completed 3/30 an inspection at its Novel Laboratories wholly-owned subsidiary in Somerset, NJ, with 13 observations. “We are confident of addressing these observations and will work closely with the agency to address their concerns,” the company says
Biologics
Outlook Therapeutics has submitted a BLA for Lytenava (bevacizumab-vikg) for treating wet age-related macular degeneration (wet AMD). “If approved, Lytenava could replace the current practice of using unapproved repackaged IV [intravenous] bevacizumab sourced from compounding pharmacies for the treatment of wet AMD,” the company says. The submission is
Devices
Medtronic has recalled a subset of IN.Pact Admiral and IN.Pact AV paclitaxel-coated percutaneous transluminal angioplasty balloon catheters due to the potential for pouch damage and a resulting loss of sterility. The company says that during a routine inspection, it detected damage to the sterile pouch that contains
Drugs
FDA is warning patients and healthcare professionals not to use products intended to be sterile produced by North American Custom Laboratories, doing business as FarmaKeio Superior Custom Compounding, Richardson, TX. An agency announcement says FDA investigators recently inspected the compounding facility and observed conditions that could cause the drugs produced
Drugs
FDA and the Federal Trade Commission (FTC) have sent Warning Letters to seven companies for selling CBD (cannabidiol) products using research studies to claim or imply misleadingly that the products will cure, mitigate, treat, or prevent Covid-19. FDA says it has not approved or authorized any drug containing CBD
FDA Policy/General
FDA is beginning a pilot program to measure the impact of announced versus unannounced GMP inspections for both domestic and foreign inspections. Speaking at the 3/8 46th International GMP Conference at the University of Georgia in Athens, ORA Office of Pharmaceutical Quality Operations director Alonza Cruse said the two-
FDA Policy/General
FDA says it will roll out this year its Enterprise Data Implementation Roadmap to shape the agency’s future by delivering successful cross-agency efforts that optimize shared business processes, enhance operational efficiency and use of data while strengthening the alignment between agency-wide strategic objectives and investments. In an