Devices
The National Council on Disability (NCD), an independent federal agency, is calling on FDA to end its enforcement discretion and regulate laboratory diagnostic tests, and particularly noninvasive prenatal screenings, that it says have made prenatal genetic testing more commonly available to women of different ages, socioeconomic backgrounds, and health histories.
Drugs
Provention Bio says its Phase 2 PRINCE clinical trial evaluating twice-daily Crohn’s disease drug PRV-6527, an oral Colony Stimulating Factor-1 Receptor (CSF-1R) small molecule inhibitor, showed that the therapy did not perform better that placebo. The study enrolled 93 moderate-to-severe Crohn’s disease
Drugs
FDA has released the FDA-483 issued following a 6/19-6/23 inspection at East Marietta Drug Company, Marietta, GA, a producer of non-sterile drug products. The three inspection observations on the form were: * production of highly potent drugs without providing adequate cleaning of work surfaces to prevent
Drugs
FDA has denied all requests in a Public Citizen 6/29/16 petition involving dopamine agonists and most requests in a BioMedEcon 6/2/17 petition involving certain specific dopamine agonists. Public Citizen had asked that FDA (1) add a Boxed Warning to labeling for all dopamine agonists describing the
Devices
Attorney Jeffrey Shapiro (Hyman, Phelps & McNamara) says FDA can resolve its “worst of all worlds” oversight of laboratory-developed tests (LDT) by standing down until Congress sets the authorized terms of the agency’s role in LDT oversight. Writing in his firm’s FDA Law Blog, Shapiro reviews the
FDA Policy/General
FDA and FTC have posted a joint Warning Letter to Rooted Apothecary (Naples, Florida) for illegally selling unapproved products containing cannabidiol online that made unsubstantiated claims for treating teething pain and ear aches in infants, autism, attention-deficit/hyperactivity disorder, Parkinson’s and Alzheimer’s disease, among other conditions or
Biologics
FDA has made available a final guidance entitled “Submitting Study Datasets for Vaccines to the Office of Vaccines Research and Review.” The technical specifications document provides detailed information and specifications for the content of datasets submitted to CBER. It is also intended to aid clinical and statistical reviewers in the
Drugs
FDA has made available a final guidance entitled “Identification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers.” The document is intended to clarify agency expectations on facility information that should be included in original NDAs, ANDAs, BLAs, and chemistry, manufacturing, and controls supplements. It discusses
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