Drugs
Vanda Pharmaceuticals is asking the DC federal court to set aside FDA’s denial of fast track status for the company’s tradipitant to treat gastroparesis and order the agency to reconsider Vanda’s application based on the statutory framework. The suit says the fast track designation is intended to
Devices
FDA has cleared a RapidAI 510(k) for its Rapid PE Triage & Notification product for identifying a suspected central pulmonary embolism. The artificial intelligence-based clinical decision support tool is designed to automatically identifies and sends notifications of suspected central pulmonary embolisms on computed tomography pulmonary angiogram images, the
Drugs
FDA has placed a clinical hold on an INmune Bio Phase 2 trial for XPro 1595, a next-generation inhibitor of tumor necrosis factor (TNF) that is designed to neutralize soluble TNF without affecting trans-membrane TNF or TNF receptors. The company says the hold is related to an agency
Drugs
FDA has released the FDA-483 issued following a 5/2-5/10 inspection at Aurobindo Pharma, a drug manufacturer in Mahaboob Nagar, Telangana, India. The inspection observations were: * investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its
Devices
The Consumer Healthcare Products Association (CHPA) says it supports FDA efforts to harmonize its current medical device Quality System Regulation with international quality management system requirements. In a comment letter, CHPA says it generally agrees with the proposed rule’s approach of incorporating ISO 13485. However, it recommends that FDA
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Risk Management Plans to Mitigate the Potential for Drug Shortages.” The document was mandated by the 2020 Coronavirus Aid, Relief, and Economic Security Act that required certain drug manufacturers to develop, maintain, and implement, as appropriate, a “redundancy risk
FDA Policy/General
Federal Register notice: FDA has proposed new regulations that would amend the requirements on current good manufacturing practices and postmarketing safety reporting that apply to certain medical gases. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is correcting a 5/11 notice entitled “Advisory Committee; Gastrointestinal Drugs Advisory Committee; Renewal” because it contained the incorrect docket number. The corrected docket number is “Docket No. FDA–2022–N–0619.” To view the notice, click here.
Drugs
FDA principal deputy commissioner Janet Woodcock and two staff from the agency’s Office of Women’s Health say there have been improvements in the representation of women in clinical trials submitted in FDA marketing applications. “We are encouraged by the potential for new strategies to further their representation,” the
Drugs
Three FDAers and an AstraZeneca researcher say physiologically-based biopharmaceutics modeling (PBBM) is an evolving field and interest in using it is increasing. Writing online in Pharmaceutical Research, the four say that FDA has emphasized the use of patient-centric quality standards and clinically relevant drug product specifications over the
Biologics
ImmunityBio has submitted a BLA for N-803, which it describes as a first-in-class IL-15 superagonist, plus Bacillus Calmette-Guérin (BCG) for treating BCG-unresponsive non-muscle invasive bladder cancer carcinoma in situ. The submission is based on data from the company’s pivotal QUILT 3032 study
Biologics
Pfizer and BioNTech say three doses of their Covid-19 vaccine had a strong immune response, high efficacy, and favorable safety in children 6 months to under age 5. “Our Covid-19 vaccine has been studied in thousands of children and adolescents and we are pleased that our formulation for
Drugs
Researchers from several universities say drug manufacturers pursue new formulations of blockbuster drugs and those granted accelerated approval, but do so less frequently once generic competition begins. Writing in JAMA Health Forum, the researchers say that in their cross-sectional study of 206 branded drugs approved by FDA in tablet
Drugs
The European Medicines Agency’s human medicines committee has recommended suspending the marketing authorizations of several generic medicines tested by India’s Synchron Research Services, a contract research organization. An EMA notice says the recommendation comes after irregularities were found in how Synchron carried out bioequivalence studies, which raised serious
Drugs
FDA has denied a 7/8/21 petition submitted by Lassman Law+Policy on behalf of an unnamed client asking that the agency take four restrictive actions related to a United Therapeutics Corporation NDA for Tvvaso DPI (treprostinil) inhalation powder. The agency denial letter says the drug’s risks are
Devices
FDA says CorneaGen recalled 1/11 one lot of scleral patch grafts that were obtained from a donor who tested reactive for HIV-1/HIV-2 Plus O antibody and HIV NAT and were shipped before being medically cleared. An agency notice says the 1/11 recall instructed customers to
Devices
FDA has granted NeuroMetrix a de novo authorization to market its Quell neuromodulation device as an aid for reducing fibromyalgia symptoms in adults with high pain sensitivity. The authorization was supported by data from a randomized, sham-controlled trial in 119 subjects with fibromyalgia. “In a pre-specified subgroup analysis
Devices
FDA has issued a warning about the risks of false results with genetic non-invasive prenatal screening (NIPS) tests. The tests provide information about the possibility of a fetus having certain genetic abnormalities that could result in a child being born with a serious health condition, an FDA release says,
Drugs
CDER says its researchers are helping to develop more realistic laboratory models of the mouth-throat region that allow the generic drug industry to efficiently test their metered-dose inhaler (MDI) products and speed access to generic products. A Center Impact Story says experiments in a recent study measured the
Drugs
Teva is recalling one lot of anagrelide capsules, USP 0.5 mg, due to dissolution test failure. The company notified customers on 5/11 that the lot was recalled. An FDA notice says Teva distributed 4,224 bottles nationwide from 7/30/2020 through 9/02/2020 to its wholesale,
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases — Questions and Answers (Revision 1).” The document is intended to provide necessary updates to the final guidance entitled “Antibacterial Therapies for Patients With
Drugs
More Product-specific Bioequivalence Guides 05/20/2022 Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances. The documents provide product-specific recommendations on, among other things, bioequivalence study design to support ANDA submissions. To view the notice, click here. Science Board to Discuss