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Federal Register notice: FDA has made available a draft guidance entitled “Testing for Biotin Interference in In Vitro Diagnostic Devices.”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.
Drugs
As ordered by a Georgia federal court, FDA has returned to Hi-Tech Pharmaceuticals over $19 million worth of DMAA (1,3-dimethylamylamine), a food additive that FDA has said is illegal to use. The product was seized over 18 months ago as part of agency enforcement action against companies
Drugs
A Federal Circuit Appeals Court ruling in Amarin v. ITC has reaffirmed the Supreme Court’s Buckman decision that only the federal government, and not private litigants, can bring suit for noncompliance with medical device requirements. Attorneys James Beck (ReedSmith) writes online in the Drug & Device Law blog the
Drugs
Certara says its Simcyp physiologically-based pharmacokinetic (PBPK) modeling and simulation technology was used to demonstrate bioequivalence (BE) in an undisclosed complex generic drug ANDA that was approved recently. “This drug approval represents a breakthrough for the industry and will help usher in a new era in which complex generic
Devices
FDA has cleared a Materialise 510(k) for its Mimics Enlight cardiovascular planning software suite. “The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures,” the company says. The device is intended to support patient selection and planning for structural heart and vascular therapy. “The TMVR
Drugs
A 12/17-12/22/18 FDA inspection at Glint Cosmetics, Maharashtra, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 5/31 Warning Letter. The letter also says the firm manufactures two unapproved new drugs and 12 products that are misbranded.
FDA Policy/General
An FDA safety alert warns about infections with multi-drug resistant organisms after patients received investigational fecal microbiota for transplantation (FMT), including one patient death. “Two immunocompromised adults who received investigational FMT developed invasive infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (E.coli),” the alert says.
Biologics
FDA has approved an Amgen BLA for Kanjinti (trastuzumab-anns), the fifth biosimilar copy of Roche’s Herceptin (trastuzumab). The approval also marks a significant FDA milestone — the 20th biosimilar approved by the agency. This includes at least one biosimilar approved for Avastin, Enbrel, Epogen/Procrit, Herceptin, Humira, Neulasta, Neupogen,
Drugs
FDA says Teva is expanding a recall to include seven additional lots of losartan potassium tablets, including three lots of 50 mg strength and four lots of 100 mg strength. An agency notice says the recall is due to unacceptable amounts of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)