Devices
FDA has granted NeuroMetrix a breakthrough designation for its Quell device and its use in treating the symptoms of fibromyalgia in adults. Quell is a wearable nerve stimulation device that provides nerve stimulation to treat fibromyalgia-related pain. The designation was based on data from a double-blind, randomized, sham-
Drugs
Ortho Regenerative Technologies says it has provided all chemistry, manufacturing, and control (CMC)-related data and characterization information requested by FDA as part of the agency’s clinical hold on the IND application for Ortho-R, a drug/biologic combination product candidate used as an adjunct to improve the success
FDA Policy/General
Beginning this month, FDA started transitioning back to standard operations for domestic inspections, according to acting commissioner Janet Woodcock. Delivering the keynote presentation at a 7/19 Regulatory Education for Industry conference, Woodcock noted how the pandemic shut down physical inspections early last year and then in July 2020 certain
Drugs
FDA has approved Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) for active immunization for preventing invasive disease caused by Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. Approval was based
Drugs
FDA has accepted for review an Aquestive Therapeutics NDA resubmission for Libervant (diazepam) Buccal Film for managing seizure clusters. The agency has set a 12/23 user fee review action target date. After receiving a complete response letter 9/2020, Aquestive received feedback from FDA outlining a path to resubmit
Drugs
FDA has approved a new use for Astellas Pharma’s Prograf (tacrolimus), based on real-world evidence (an observational study), for use in combination with other immunosuppressant drugs to prevent organ rejection in adult and pediatric patients receiving lung transplantation. The drug was originally approved for preventing organ rejection in
Drugs
FDA is pushing for a “major paradigm shift” to move the clinical development community from “systemic exclusion to the inclusion” of pregnant and breastfeeding women in clinical studies. Writing in an online FDA Voices post, officials say it is time to give this patient population needed data about the safety
Devices
FDA has granted Endologix a breakthrough device designation for its ChEVAS (Chimney EndoVascular Aneurysm Sealing) System, an endovascular abdominal aortic aneurysm (AAA) sealing therapy. The device is designed to combine the company’s Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal and
Drugs
Ardelyx says it received a letter from FDA saying that as part of its ongoing review of the company’s NDA for tenapanor, it found deficiencies that preclude discussion of labeling and post-marketing requirements/commitments at this time. The submission is seeking an indication for controlling serum phosphorus in
Devices
FDA has approved a Nevro Corp. PMA for its Senza System for treating chronic pain associated with painful diabetic neuropathy. The approval is specific to Nevro’s unique 10 kHz stimulation, the company says. Approval was based on data showing that study participants demonstrated significantly improved and sustained outcomes with
FDA Policy/General
Guide on Product-specific Bioequivalence 7/16/2021 Federal Register notice: FDA has made available a draft guidance entitled “Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam.” The document provides product-specific recommendations on the bioequivalence study designs to support ANDA submissions for such products. To view the notice, click here.
Drugs
FDA’s Cardiovascular and Renal Drugs Advisory Committee 7/15 overwhelmingly voted against recommending approval for a FibroGen NDA for roxadustat, indicated for treating anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. Committee members agreed with an FDA briefing document citing risks of
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Draft Guidance for Cilastatin Sodium; Imipenem; Relebactam.” The document provides product-specific recommendations on the bioequivalence study designs to support ANDA submissions for such products. To view the notice, click here.
Biologics
FDA has granted Pfizer/BioNTech a priority review for a BLA for their mRNA vaccine to prevent Covid-19 in individuals 16 years of age and older. The submission would move the vaccine’s regulatory status from an emergency use authorization (EUA) to full BLA approval. The agency has set
Devices
KorvaLabs has requested that its emergency use authorization for the Curative SARS-Cov-2 (Covid-19) test be revoked because it is now using different EUA-authorized tests for the testing offered at its laboratories. The Curative test was the subject of a January FDA safety alert about false result
Devices
FDA has cleared a Dexcom 510(k) for its Dexcom Partner Web application programming interface (API) to enable invited third-party developers to integrate real-time continuous glucose monitoring data into their digital health apps and devices. “Several prominent diabetes and digital health companies have been invited to access the
Drugs
FDA has approved a Kadmon Pharmaceuticals NDA for Rezurock (belumosudil), a kinase inhibitor for treating adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy. Approval was based on data from KD025-213 (NCT03640481), a
Drugs
FDA has placed the Jubilant Pharmova dosage formulation facility at Roorkee, India, under an import alert following a March inspection. The company says the facility received an OAI (official action indicated) designation in 12/2018 and a Warning Letter in 3/2019. It says FDA exempted from the import alert
Devices
Members of the FDA Gastroenterology and Urology Devices Panel voted 12-1-1 on 7/14 that the benefits of the TransMedics OCS (organ care system) liver preservation system outweigh its risks. Votes on the device’s safety and effectiveness were unanimously supportive, MedTechDive reports. The online report says the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a proposed information collection entitled “Medical Conference Attendees’ Observations About Prescription Drug Promotion.” The study is intended to focus on understanding the landscape of healthcare provider-directed promotion of prescription drugs at medical conferences in general. More specifically, it will examine elements
FDA Policy/General
Two Arnold & Porter attorneys say the issue of whether real-world evidence (RWE) will be accepted for use in drug advertising by regulators in FDA and around the world will depend on the quality and completeness of the data and the relevance of and purpose for which it will
Drugs
A 6/2021 FDA draft guidance clarifies the enhanced system requirements listed in the Drug Supply Chain Security Act (DSCSA) and gives recommendations on the system attributes necessary for enabling the secure tracing of product at the package level, including allowing for the use of verification, inference, and aggregation as