FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Premium Production, Saint George, UT (7/29): FDA inspected the firm in February and cited serious GMP violations for dietary supplements. For example, the firm failed to establish specifications
Biologics
FDA says it is confident that AveXis’ Zlogensma, a gene therapy product intended to treat children less than two years old with spinal muscular atrophy with bi-allelic mutations in the survival motor neuron 1 gene, that was approved by the agency 5/24, should remain on the market despite
Drugs
Hoffman-LaRoche and Genentech say they appreciate that an FDA draft guidance on enhancing the diversity of clinical trial populations takes a multifaceted approach. “However,” the companies’ comment letter says, “we believe that some of the recommendations provided in the draft guidance could be further expanded or clarified with regard
FDA Policy/General
Federal Register notice: FDA has announced the rates for biosimilar user fees for fiscal year 2020. They are: Applications requiring clinical data ($1,746,745), applications not requiring clinical data ($873,373), biological product development fee ($117,987), annual product development fee ($117,987), and program fee ($304,162). To
Drugs
An amended complaint by Pharmaceutical Research and Manufacturers of America (PhRMA) against a California drug pricing disclosure law has been given more stable footing after a federal court allowed the lawsuit to move forward. The controversial California law (see earlier story) requires pharmaceutical manufacturers to provide advance notice when raising
Drugs
AbbVie has submitted an NDA for elagolix, an oral gonadotropin-releasing hormone (GnRH) antagonist with a proposed indication for managing heavy menstrual bleeding (HMB) associated with uterine fibroids. The submission is based on data from the elagolix Phase 3 uterine fibroid program, which evaluated nearly 800 premenopausal women with uterine
Devices
Legislation is needed to codify changes FDA is seeking to its medical device 510(k) program to reduce the reliance of equivalence to a predicate device and transition to a system where new devices demonstrate improved safety and effectiveness compared with marketed devices for the same clinical purpose, according to
Drugs
Foamix Pharmaceuticals has submitted an NDA seeking approval for FMX103 foam for treating moderate-to-severe papulopustular rosacea in patients aged 18 years and older. The NDA submission is supported by data from two Phase 3 clinical trials, FX2016-11 and FX2016-12. “In these trials, FMX103 achieved both co-
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment.” The document is intended to aid in consistency of reviews, testing, and MRI safety labeling for medical devices. To view the notice, click here.
Drugs
FDA has approved Bracco Diagnostics’ Aribar Thin Liquid (barium sulfate) for oral suspension, indicated for modified barium swallow (MBS) studies used to detect and assess the type and severity of swallowing disorders (dysphagia). During an MBS, a patient swallows products with different thicknesses containing a barium x-ray contrast agent,
Devices
Abbott has recalled its Ellipse Implantable Cardioverter Defibrillators (ICDs) after electrical failures had been identified and determined to be due to a faulty manufacturing process causing some aluminum wires to be partially exposed. This makes them prone to electrical shorting of the capacitor, a recall notice says. If a short
Drugs
Draft Guide on Clin-Pharm Considerations for Neonatals Federal Register notice: FDA makes available a draft guidance entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.” 08/02/2019 Nonclinical Toxicology Studies Q & A Draft Guide Federal Register notice: FDA makes available a draft guidance
FDA Policy/General
Otsuka Pharmaceutical and Medimetriks Pharmaceuticals have entered into a licensing agreement granting Medimetriks exclusive development and commercialization rights for a topical non-steroidal phosphodiesterase IV inhibitor, OPA-15406, in the U.S. and Puerto Rico for treating atopic dermatitis. According to the companies, OPA-15046 demonstrated clinically significant results vs.
FDA Policy/General
BIOLOGICS FDA has approved the composition of Protein Sciences Corp.’s Flublok influenza vaccine for the 2015-16 flu season. The company says there are two strain changes this year. DEVICES FDA has cleared a Cardiovascular Systems 510(k) for its ViperWire Advance Peripheral Guide Wire with Flex Tip for
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “General Clinical Pharmacology Considerations for Neonatal Studies for Drugs and Biological Products.” The document was mandated under the FDA Reauthorization Act of 2017 (FDARA). To view the notice, click here.
Devices
FDA has cleared a Medicrea Group 510(k) for its Tulip Genesis for use with the UNiD Adaptive Spine Intelligence platform technology. Tulip Genesis is described by Medicrea as a state-of-the-art comprehensive top loading screw system that offers solutions for both degenerative and complex deformity spinal cases.
Drugs
FDA has allowed Momenta Pharmaceuticals to proceed under its IND to begin an adaptive Phase 2/3 clinical study for its FcRn inhibitor nipocalimab (M281) in warm autoimmune hemolytic anemia (wAIHA). If successful, the adaptive Phase 2/3 study could serve as a pivotal study which could enable nipocalimab to
Drugs
FDA has approved a Daiichi Sankyo NDA for Turalio (pexidartinib) capsules for treating adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery. TGCT is a rare tumor that affects the synovium (thin layer of tissue that
Devices
Qiagen has recalled filter tips used with the QIAsymphony SP/AS instruments due to their potential to leak, which may result in delayed or inaccurate results. The pipetting system filter tips are used for clinical assay workflows or with in vitro diagnostic tests. “Due to a manufacturing malfunction resulting in
Devices
Teleflex has recalled certain Sheridan endotracheal tubes and connectors, which are also used in Centurion’s convenience kits. “Teleflex recalled multiple models of the Hudson RCI Sheridan and Sheridan endotracheal tubes due to reports of the Sheridan endotracheal tube connector dislodging from the endotracheal tube, causing disconnection of the patient
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Pathology Peer Review in Nonclinical Toxicology Studies: Questions and Answers.” The document is intended to address documentation practices during pathology peer review, which FDA says have not been clearly defined and vary among nonclinical testing facilities. To view the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Bacterial Vaginosis: Developing Drugs for Treatment.” The document is intended to assist sponsors in the clinical development of such drugs. Changes incorporated in the final guidance include clarification about the timing of the primary efficacy endpoints, which are based