Devices
FDA has cleared a Canon Medical Systems 510(k) for the Aquilion Exceed LB CT system, which is intended to provide clinicians the opportunity to see more during radiation therapy planning to improve accuracy, precision and speed. The device features a large bore opening (90 cm), edge-to-edge extended
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says an FDA draft guidance, Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development Under the BPCI Act, should be revised to provide more complete guidance related to interchangeable products, including on: * consideration for developing presentations, container closure systems, and delivery
Drugs
FDA has approved ViiV Healthcare’s Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a complete regimen for treating HIV-1 infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known
Drugs
FDA has accepted two Bristol-Myers Squibb sBLAs for new indications for its Opdivo (nivolumab). The first sBLA is to treat patients with resected esophageal or gastroesophageal junction cancer in the adjuvant setting, after neoadjuvant chemoradiation therapy. The agency granted the application priority review and set a PDUFA goal date
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Multix Impact C ceiling-mounted digital radiography (DR) system as well as the Multix Impact VA20, a new version of the established floor-mounted parent DR system. Both devices feature intuitive operating systems, versatile wireless detectors, motorized tube heads, and
Drugs
FDA has accepted for review an Impel NeuroPharma 5O5(b)(2) NDA for INP104 (dihydroergotamine mesylate) for the acute treatment of migraine headaches with or without aura in adults. The company says INP104 is intended to be delivered directly into the vascular-rich upper nasal space using Impel’s proprietary
FDA Policy/General
Federal Register notice: FDA has issued a final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The rule is intended to help ensure that PMTAs contain sufficient information for FDA to determine whether a
FDA Policy/General
Outgoing FDA commissioner Stephen Hahn said 1/19 that the agency does not support a memorandum of understanding (MOU) signed that day by Department of Agriculture (USDA) secretary Sonny Perdue and HHS assistant secretary Brett Giroir establishing a regulatory environment for agricultural animal biotechnology innovation. In a series of Tweets,
FDA Policy/General
Federal Register notice: FDA and HHS have revised proposal requests for reimporting insulin and the personal importation of prescription drugs that appeared in the 9/24/2020 Federal Register. Proposals submitted in response to the requests will be accepted and reviewed on a rolling basis, and until further notice. To
Drugs
FDA has denied without comment an 11/1/19 GlaxoSmithKline petition asking that the agency review four categories of information concerning the use of Zofran (ondansetron) in pregnancy and “either refrain from taking action to alter Zofran’s pregnancy-related labeling or take action to alter the labeling in light
Drugs
FDA has approved Merck’s Verquvo (vericiguat), a soluble guanylate cyclase stimulator, to reduce the risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%. Merck says
Biologics
The Peggy Lillis Foundation for C. Diff Education and Advocacy is asking FDA to take several actions to improve the availability of microbiome treatments for C. difficile infections. The 1/12 petition asks FDA to: * engage patients and caregivers in developing agency guidelines for potential new therapies for C. difficile,
Drugs
FDA reportedly has verbally notified Histogen that the agency has additional questions about the company’s IND application package for a planned Phase 1/2 clinical trial of its HST-003, intended to evaluate the safety and efficacy of human extracellular matrix implanted within microfracture interstices and the cartilage defect
FDA Policy/General
Federal Register notice: FDA is issuing a final rule to provide additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also establishes general procedures FDA intends to follow when evaluating SE Reports, including procedures that address communications
Drugs
FDA has deferred a review action on GlaxoSmithKline’s PD-1 drug dostarlimab, indicated for treating endometrial cancer, because it could not conduct a manufacturing site inspection due to Covid-19 concerns. The company is telling several media outlets that while the site inspection has not occurred yet, it is
FDA Policy/General
As the transition of power concludes in Washington, DC and CDER director Janet Woodcock assumes temporary control of FDA until a new commissioner is appointed, we are reminded just how important an independent and a free-from-political-interference agency really matters. A Vanity Fair special report examines how former
Devices
FDA has cleared an Eitan Medical 510(k) for its upgraded Sapphire infusion pump system and software Rev15, which includes pump, administration sets and accessories. The device is designed to deliver a wide range of therapies for varied clinical uses, such as saline, total parenteral nutrition, lipids, IV medication, perineural
Drugs
L.E.K. Consulting says that FDA approval for a new drug is no guarantee of commercial success. In a report on lessons learned from the company’s Launch Monitor, L.E.K. says that to drive real value, biopharma companies must execute the launch process flawlessly. “As history shows,
FDA Policy/General
Federal Register Final Rule: The Regulatory Flexibility Act (RFA) requires agencies like FDA to publish plans to conduct periodic reviews of certain of their regulations. To further comply with the RFA and subsequent executive orders, and to ensure the department’s regulations have appropriate impacts, HHS is issuing the final
Drugs
FDA has removed a partial clinical hold on a Pieris Pharmaceuticals Phase 1 study of PRS-343 that was issued while the company conducted an additional in-use and compatibility study requested by the agency. Currently-enrolled patients were permitted to continue to receive treatment, the company said, but no
Biologics
FDA commissioner Stephen Hahn and senior advisor Colin Rom say the agency has signed a memorandum of understanding (MOU) with the National Institute of Standards and Technology (NIST) to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products, and medical devices through the adoption
Drugs
FDA has released the 39-page FDA-483 containing 13 detailed observations issued following a 9/10-11/5/2020 inspection at Novel Laboratories, doing business as Lupin, Somerset, NJ. The inspection observations were: * failing to clean and sanitize at appropriate intervals equipment and utensils to prevent malfunctions and contamination