Drugs
A 4/1-4/5 FDA inspection at Jiangsu NHWA Pharmaceutical Co., Jiangsu Sheng, China, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs). A just-released 9/10 Warning Letter says specific deviations were: * failing to ensure that all sampling plans and test procedures
FDA Policy/General
FDA said it has granted its first authorizations for marketing eight smokeless tobacco products approved through the modified risk tobacco product pathway. The authorizations are for eight Swedish Match USA, Inc., snus smokeless tobacco products sold under the “General” brand name. An agency statement says the products were previously authorized
Drugs
FDA has accepted for review an IntelGenx 505(b)(2) NDA resubmission for Rizaport VersaFilm (rizatriptan ) an oral disintegrating film for treating acute migraine. Rizatriptan is the active ingredient in Merck’s migraine drug Maxalt-MLT. IntelGenx says the selective 5-HT1B/1D receptor agonist demonstrates the highest efficacy and
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Jiangsu NHWA Pharmaceutical Co., Jiangsu, China (9/10): FDA inspected the firm in April and cited significant GMP deviations for active pharmaceutical ingredients (APIs). For example, the company failed
Drugs
The Gastroparesis Clinical Research Consortium says it agrees with many statements in a recent FDA guidance on gastroparesis that “provides much needed information for conducting clinical trials for pharmaceutical companies for drug approval for gastroparesis.” The consortium’s comment letter raises concerns in these areas: * FDA is sending a conflicting
Devices
FDA has granted Garwood Medical a Breakthrough Device designation for its BioPrax device, which is under investigation to help eliminate biofilm infections on prosthetic knee implants during early intervention procedures. The device provides a low-voltage electrical treatment to the surface of a knee implant, creating an environment that kills
Drugs
FDA has approved a Vertex Pharmaceuticals NDA for Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy to treat patients with the most common cystic fibrosis mutation. Trikafta gained approval for patients 12 years and older with cystic fibrosis who have at least one F508del mutation in the cystic fibrosis
Drugs
FDA has approved AstraZeneca’s Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure in adults with Type-2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. Approval is based on data from the DECLARE-TIMI 58 cardiovascular outcomes trial. The first-in-class, oral once-
Biologics
FDA has approved an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) for treating atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA) for adult and pediatric patients. The ultra-rare disease can cause progressive injury to vital organs, primarily the kidneys, by damaging walls of blood vessels.
Drugs
FDA has made available a draft guidance entitled “Drug Master Files.” The document provides current thinking on the submissions that may be used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. DMFs can contain other types
Drugs
Several lawmakers have written a letter to FDA acting commissioner Ned Sharpless seeking more information about a recent Takeda Pharmaceuticals recall of its hypoparathyroidism drug Natpara (parathyroid hormone). The letter notes that more than 2,000 need the drug to manage their blood calcium levels. It says several patients who
Drugs
Bayer has submitted a supplemental NDA to extend the duration of use for its intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg. The submission seeks to extend the indication to up to six years of pregnancy prevention based on results from a Phase 3 extension trial evaluating Mirena’s
Devices
FDA has cleared a Canon Medical Systems 510(k) for its Advanced Intelligent Clear-IQ Engine (AiCE) for use on the Aquilion Precision CT Scanner. The device uses a deep learning algorithm to differentiate signal from noise for computed tomography (CT) image reconstruction. Its ultra-high resolution CT provides two
Drugs
FDA has released a Form-483 from a July inspection at Ram Pharma’s Idaho Falls, ID outsourcing facility. According to the inspection observations, aseptic processing areas were found deficient, particularly the system for monitoring environmental conditions. The agency also cited the firm’s system for cleaning and disinfecting the
FDA Policy/General
Draft Guide on Drug Master Files Federal Register notice: FDA makes available a draft guidance entitled “Drug Master Files.” 10/18/2019 10 Info Collections Approved by OMB Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB. 10/18/2019 FDA/
Drugs
BIOLOGICS CSL Behring has received FDA approval of Idelvion [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], its novel, long-acting albumin fusion protein linking recombinant coagulation factor IX with recombinant albumin for treating hemophilia B. The company says Idelivion is the first factor IX therapy that delivers high-level protection
Devices
FDA has cleared an Ortho Clinical Diagnostics 510(k) for the ORTHO Sera, a series of extended antigen phenotyping for use on the Ortho Vision Analyzer. The device’s extended phenotype testing covers more than 99% of the most commonly tested blood group antigens to support for patients with unexpected
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Drug Master Files.” The document provides FDA’s current thinking on submissions that may be used to provide confidential, detailed information about facilities, processes, or articles used in drug product manufacturing, processing, packaging, and storing. of human drug products.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been recently approved by OMB. They are: 1. Export of Medical Devices; Foreign Letters of Approval 2. Registration of Food Facilities 3. Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of
Drugs
American Gene Technologies (AGT) has submitted an IND for its lead HIV program, AGT103-T, a single-dose, lentiviral vector-based gene therapy being developed for eliminating HIV from people infected with the disease. The genetically-modified cell product is made from a person's own cells, and it
Drugs
FDA says Johnson & Johnson has recalled one lot of its Johnson’s Baby Powder (Lot #22318RB) after an agency sample detected chrysotile fibers, a type of asbestos. The sampling is part of FDA’s ongoing survey of cosmetic products for asbestos, which started in 2018. The agency says it
Devices
Nuvectra has submitted FDA-requested data to allow the agency to complete its review of a 2017-submitted PMA for Virtis, a sacral nerve stimulation (SNS) system for treating chronic urinary retention and overactive bladder symptoms. The company recently submitted supplementary chemical composition and biocompatibility data. The company says that