Devices
FDA has cleared a 410 Medical 510(k) for its LifeFlow device for rapid delivery of blood and blood components, in addition to its previous clearances for crystalloid and colloid resuscitative fluids. The device is intended for treating severe hemorrhage, which is a leading cause of preventable death from trauma
Drugs
FDA has made “modernized” changes to its Phonetic and Orthographic Computer Analysis (POCA) program, the agency’s software tool that uses an advanced algorithm to determine the orthographic and phonetic similarity between two drug names. “The program can compare a drug name against multiple drug names found in several different
FDA Policy/General
House Energy and Commerce Committee leadership has denounced the White House after it blocked FDA commissioner Stephen Hahn from testifying before the committee this month about potential political interference into Covid-19 response efforts. “The American people deserve to hear Commissioner Hahn’s response to those concerns during a public
Drugs
Medimetriks Pharmaceuticals says it received a Type C Meeting written response from FDA on MM36 (difamilast) for the topical treatment of mild to moderate atopic dermatitis (AD). Based upon the response, Medimetriks says it is preparing to conduct a single pivotal trial in the U.S. for an NDA, which
Drugs
FDA has granted Junshi Biosciences an orphan drug designation for toripalimab and its use in treating soft tissue sarcoma. This is the third such designation granted to Toripalimab, with earlier designations for treating mucosal melanoma and nasopharyngeal carcinoma. Soft tissue sarcoma is a rare heterogeneous tumor with complex pathological types
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) is planning to question healthcare providers about their view of prescription drug promotion in exhibit halls at medical conferences. A Federal Register notice says the research will look specifically at how elements of pharmaceutical booths in medical conference exhibit halls affect healthcare
Devices
FDA has published comparative performance data for more than 55 authorized molecular diagnostic Covid-19 tests against a standardized sample panel provided by the agency. An FDA statement says it provided the reference panel to test developers who are required to assess their tests’ performance against the panel or other
Devices
FDA has cleared a Acutus Medical 510(k) for the second-generation AcQMap 3D imaging and mapping catheter. The device combines 48 ultrasound transducers responsible for creating an “anatomical geometry” and 48 engineered electrodes which enable “electrical activation patterns” to be displayed along the inner surface of the heart. “Compatible
Biologics
Former FDA associate commissioner for public health strategy and analysis Peter Lurie says industry data showing that only 10% to 14% of compounds entering human testing in the last several decades were ultimately approved should be used to caution the public not to expect that all Covid-19 vaccines will
FDA Policy/General
Federal Register notice: FDA is proposing to reclassify Class 3 cytomegalovirus deoxyribonucleic acid (DNA) quantitative assay devices intended for transplant patient management into Class 2 (general controls and special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name “quantitative cytomegalovirus nucleic acid
FDA Policy/General
Federal Register notice: FDA is withdrawing the approval of two Eisai NDAs for Belviq (lorcaserin HCl) tablets and Belviq XR (lorcaserin HCl) extended-release tablets, indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in certain adults. In 2019, FDA issued a
Drugs
FDA has accepted for review a ChemoCentryx NDA for avacopan, an orally-administered selective complement 5a receptor inhibitor for treating antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis. The agency has set a 7/7 user fee review action target date. The company says ANCA-associated vasculitis is a systemic disease in
Drugs
The Justice Department says a 16-count indictment charges that two Florida men conspired to pay and receive kickbacks in connection with prescribing an Insys fentanyl spray. Those charged were pain management doctor Steven Chun and former Insys sales representative Daniel Tondre. A department statement says that Insys sales representatives
Drugs
FDA Office of Dietary Supplement Programs director Steven Tave told the 2020 Dietary Supplement Regulatory Summit 9/16 that while it is not correct to say that the dietary supplements industry is not regulated, “we can comfortably say at a minimum that the dietary supplement market isn’t perfectly regulated.
Drugs
FDA has accepted for priority review a CytRx NDA for arimoclomol for treating Niemann-Pick disease Type C. CytRx says that arimoclomol works by amplifying the production of heat-shock proteins, which can rescue defective misfolded proteins, clear protein aggregates, and improve the function of lysosomes. The agency has set
Drugs
President Trump and his administration’s “meddling for political purposes” in FDA and CDC activities related to Covid-19 puts the nation at risk, warns a Washington Post editorial board opinion piece. The Post looks at Trump’s touting of hydroxychloroquine and the expanded use of convalescent plasma as examples
Drugs
FDA says that stakeholders concerned about protecting proprietary information during the development of drugs containing cannabis and cannabis-derived compounds should consider using the drug master file (DMF) pathway. The agency explained the potential use of the DMF pathway for cannabis drug development during a recent Webinar that covered DMFs
FDA Policy/General
Federal Register notice: FDA has issued a priority review voucher to AstraZeneca for an approved rare pediatric disease product — Koselugo (selumetinib), indicated for treating pediatric patients two years of age and older with neurofibromatosis Type 1 who have symptomatic, inoperable plexiform neurofibromas. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Geriatric Information in Human Prescription Drug and Biological Product Labeling. The document provides recommendations to help ensure that appropriate geriatric information is consistently placed in the proper sections and subsections within labeling. It also provides examples of geriatric use
Drugs
The California legislature has passed SB 852 that would require the state to partner with industry “to produce or distribute generic prescription drugs and at least one form of insulin, provided that a viable pathway for manufacturing a more affordable form of insulin exists at a price that results in
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Eosinophilic Esophagitis: Developing Drugs for Treatment. The document addresses the agency’s current thinking about clinical trials and development programs for such drugs, including recommendations for the necessary attributes of patients for enrollment, trial design, efficacy considerations, safety assessments,
Drugs
The DC federal court says FDA misinterpreted the Federal Food, Drug, and Cosmetic Act (FFDCA) when it approved Lannett’s Numbrino (cocaine HCl) nasal solution during the period of Genus Lifesciences’ five-year new chemical entity exclusivity for Goprelto (cocaine HCl) nasal solution. Genus filed suit after the agency approved