Drugs
A just-posted article in BMC Medicine finds that about half of studies FDA requires in post-marketing commitments are ever published in peer-reviewed journals. “Postmarketing commitments are studies that drug companies agree to conduct at the time of FDA approval, and are not required by statute or regulation,
Drugs
Sen. Bernie Sanders (I-VT) and Rep. Elijah E. Cummings (D-MD) are urging the Justice Department to investigate 20 generic drug manufacturers for allegedly engaging in a price-fixing scheme. “It is sick and disgraceful that generic pharmaceutical executives, who should be making medicines affordable for the American people,
Devices
FDA has granted Bio-Techne a breakthrough device designation for its ExoDx Prostate IntelliScore test, which the company says is the first exosome-based liquid biopsy test to receive such a designation. The breakthrough program is designed to expedite the development, assessment and review of certain devices through interactive and
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in selecting nonvoting industry representative to serve on CBER’s Allergenic Products Advisory Committee notify FDA in writing. The agency is also requesting nominations for nonvoting industry representatives to serve on the committee. To view the notice,
Devices
FDA has approved Cochlear Limited’s new Cochlear Nucleus Profile Plus Series Cochlear Implant and the Nucleus 7 Sound Processor’s new built-in connectivity featuring direct streaming with compatible Android smartphones. The device is designed for safe access to magnetic resonance imaging scans without the need to remove the
Drugs
FDA has granted NuCana an orphan drug designation for its investigational drug, Acelarin (NUC-1031), and its use in treating biliary tract cancer. The company describes the new chemical entity as its “ProTide transformation of gemcitabine... Our Phase 1b study of Acelarin combined with cisplatin showed an approximate doubling of
Drugs
FDA has approved an expanded use for Novo Nordisk’s Victoza (liraglutide) for improving blood sugar control in pediatric patients with Type 2 diabetes. “Victoza improves blood sugar levels by creating the same effects in the body as the glucagon-like peptide (GLP-1) receptor protein in the pancreas,” an
FDA Policy/General
Testing for Biotin Interference in IVDS Federal Register notice: FDA makes available a draft guidance entitled “Testing for Biotin Interference in In Vitro Diagnostic Devices.” 06/14/2019 FDA Withdraws 12 No-longer Marketed ANDAs Federal Register notice: FDA withdraws approval of 12 ANDAs from multiple applicants after they notified
FDA Policy/General
Advanced Botanical Consulting and Testing, Tustin, CA (6/4): FDA inspected the contract testing laboratory 11/2018 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods. FDA said it did not use
FDA Policy/General
DEVICES FDA has cleared an AnthroTronix 510(k) for its computerized cognitive test battery DANA, which is intended to provide clinicians with objective measurements of reaction time (speed and accuracy) to aid in the assessment of an individual’s medical or psychological state. The phone and tablet based app is
Drugs
FDA has revised its guidance on “ANDA Submissions — Content and Format.” The document is intended to assist applicants in preparing ANDAs and it details the information that should be provided in each section of the common technical document (CTD) format. The CTD collects quality, safety, and efficacy information into a
Devices
Patients and consumers worried about dental amalgam’s mercury content and its risks have taken on a campaign to urge FDA action by submitting almost 200 comments to an agency docket seeking input on Patient Preference Information related to medical device regulatory decisions. As of 6/14, 94% of comments
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Testing for Biotin Interference in In Vitro Diagnostic Devices.” The document provides FDA’s recommendations on the testing for interference by biotin on the performance of in vitro diagnostic devices. It is intended to help device developers and clinicians
Drugs
Merck, Eli Lilly and Amgen have filed suit in DC federal court seeking to stop an HHS rule to include drug prices in direct-to-consumer ads. Joined by the Association of National Advertisers, the complaint contends that the rule violates the companies’ First Amendment rights, and it would mislead
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of 12 ANDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is requesting that any consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to serve on its advisory committees or panels notify the agency in writing. FDA is also requesting nominations for voting or nonvoting consumer representatives to serve on advisory committees for
FDA Policy/General
Federal Register notice: FDA has announced a 7/31 Psychopharmacologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Intra-Cellular Therapies NDA for lumateperone tosylate capsules, indicated for treating schizophrenia. To view the notice, click here.
Drugs
At FDA’s request, U.S. marshals have seized more than 300,000 dietary supplement containers, including tablets, capsules, and teas from Life Rising Corp. The seized goods comprised more than 500 products bearing brand names Life Rising, Holicare, or HopeStream. Northern Illinois federal court determined there was probable cause
Devices
FDA is publishing a draft guidance, Testing for Biotin Interference in In Vitro Diagnostic Devices, with agency recommendations. The document is intended to help medical device developers and clinicians understand how the agency recommends biotin interference testing should be performed and how the results of testing should be communicated to
Drugs
FDA has selected IBM, KPMG, Merck, and Walmart to participate in a pilot program to assist drug supply chain stakeholders in developing an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the U.S. The pilot will use IBM blockchain technology that will
FDA Policy/General
Federal Register notice: FDA has announced a 7/25 Arthritis Advisory Committee meeting to discuss a Boehringer Ingelheim supplemental NDA for Ofev (nintedanib) capsules, indicated for treating systemic sclerosis-associated interstitial lung disease. The panel will discuss whether the application provides substantial evidence of efficacy for the proposed indication. To
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Mouse Embryo Assay for Assisted Reproduction Technology Devices.” The document provides recommendations on conducting a mouse embryo assay to support premarket submissions and lot release of assisted reproduction technology devices. To view the notice, click here.