Drugs
FDA has published a guidance, Application of Human Factors Engineering Principles for Combination Products: Questions and Answers, with questions and answers on applying human factor engineering (HFE) principles to developing combination products. The document finalizes a 2/2016 draft and clarifies how the unique aspects of a combination product influence
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it applauds efforts by the International Council for Harmonization (ICH) and FDA to facilitate harmonized scientific and regulatory considerations for Good Clinical Practice (GCP). Responding to FDA’s publication of the ICH E6(R3) draft guideline, PhRMA says it supports the revision
Biologics
Moderna says its updated Covid-19 vaccine, which is awaiting FDA approval, generated a strong immune response against the BA.2.86 (Pirola) variant that the Centers for Disease Control has said might be more likely to break through existing immunity from previous vaccinations because it has over 30 mutations.
Drugs
FDA’s Oncology Center of Excellence and Flatiron Health have renewed a five-year collaboration to jointly develop and implement specific research projects to advance real-world data (RWD) use and explore strengths and limitations with using real-world evidence (RWE) for regulatory purposes. “The partnership will specifically evaluate RWD
Devices
FDA has granted Admetsys a breakthrough device designation for its automated glucose control and continuous blood diagnostics system. The device is intended to automatically measure multiple blood analytes, including glucose, in real-time with no patient blood loss. “From this, it creates an adaptive, computational model of each patient’s
Devices
FDA has published three draft guidances that, when finalized, will provide updated recommendations on specific aspects of the medical device 510(k) program. An online 510(k) update (contains links to the new guidances) says the drafts are “informed by a 2019 request for public feedback to continue to modernize
Drugs
The FDA Office of New Drugs will hold an 11/13-11/14 meeting on “Positron Emission Tomography: Product Quality Regulatory Submissions, Facility Inspections, and Benefit-Risk Considerations.” An online notice says the purpose of the session is to provide a forum for the exchange of information and perspectives on
Drugs
Janssen says its Rybrevant (amivantamab-vmjw) met the MARIPOSA-2 dual primary endpoints, showing statistically significant and clinically meaningful improvement in progression-free survival plus chemotherapy with and without lazertinib (Janssen’s Leclaza) versus chemotherapy alone in patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer
Biologics
FDA has denied a 10/28/2020 petition submitted by the Informed Consent Action Network (ICAN) asking that the agency require all manufacturers of acellular pertussis-containing vaccines to amend their labeling and package inserts to state that the vaccines do not prevent infection and transmission of pertussis. “Your petition
Drugs
FDA has issued AstraZeneca’s Alexion unit a complete response letter (CRL) on a supplemental BLA for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz). The suupplent sought expanded use in treating adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 antibody positive (Ab+). The company
Drugs
FDA has approved Boston Scientific’s latest generation of its Watchman FLX Pro Left Atrial Appendage Closure (LAAC) device, indicated for reducing stroke risk in patients with non-valvular atrial fibrillation who need an alternative to oral anticoagulation therapy. The new device features a polymer coating, visualization markers, and a
Drugs
A 2/13-2/28 FDA inspection at the Lex, Inc., drug manufacturing facility in Medley, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/17 Warning Letter says the violations were: * failure of the quality control unit to exercise its responsibility to
Drugs
FDA says a review of records submitted by Green Pharmaceutical Co., registered with the agency as a manufacturer of over-the-counter drugs in Jincheon, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 8/23 Warning Letter says the specific violations were:
Drugs
FDA has published a guidance, DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs, to identify the standards necessary to facilitate the adoption of secure, interoperable, electronic data exchange among the pharmaceutical distribution supply chain. The document also clarifies the trading partners, products,
Devices
FDA has published a statement, Emergency Preparedness and Medical Devices: Supply Chain Recommendations for Healthcare Providers, Device Manufacturers, and Distributors, with best practices for healthcare providers and systems, medical device manufacturers, and distributors to consider while preparing for natural disasters and other emergencies. In addition to specific recommendations for providers,
Devices
FDA has granted Xenex Disinfection Services a de novo marketing authorization for the company’s LightStrike+ device, a high-intensity, broad-spectrum ultraviolet (UV) light robot intended for use in reducing pathogens on non-porous, high-touch surfaces in healthcare environments. The robot uses a xenon lamp to create high-
Drugs
A group of five doctors and eight organizations have submitted a citizen petition to FDA calling for urgent action on the off-label use of GnRH agonists, a class of drugs also known as puberty blockers. “We are concerned by the dramatic increase in the off-label use of puberty
Drugs
Six Epstein Becker Green attorneys say an 8/15 FDA final guidance on informed consent for clinical investigations updates the agency’s 7/2014 draft guidance and supersedes a 9/1998 guide to informed consent. The attorneys say the final guidance: * summarizes the informed consent process; * outlines and discusses FDA’
Drugs
X4 Pharmaceuticals has submitted an NDA for a once-daily, oral mavorixafor to treat individuals aged 12 and older with WHIM (warts, hypogammaglobulinemia, infections, and myelokathexis) syndrome, a rare immunodeficiency. The submission is supported by data from the pivotal 4WHIM Phase 3 clinical trial in individuals with WHIM syndrome. The
Drugs
Seagen and Genmab’s cancer drug Tivdak (tisotumab vedotin-tftv) met its primary endpoint of overall survival in their confirmatory Phase 3 innovaTV 301 trial, the companies said 9/5. The study was conducted in recurrent or metastatic cervical cancer patients with disease progression on or after front-line therapy,
FDA Policy/General
The 5th Circuit Court of Appeals has reversed a Texas federal court’s decision dismissing a suit filed by three doctors against FDA and HHS challenging the agencies’ messaging advising against using ivermectin to treat Covid-19. The appeals court sent the case back to the Texas federal court for
Devices
FDA has cleared a Techsomed 510(k) for its VisAble.IO software intended to assist physicians in planning liver ablation procedures and confirming ablation zones. The device uses the company’s BioTrace solution, an “end-to-end software solution for full visualization and control for image guided ablation therapy,” Techsomed