FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biotek Inc. Layton, UT (3/13): FDA inspected the firm 8/2017 and cited it over product claims that cause its dietary supplements to be unapproved drugs. For example,
Drugs
Attorneys Erika Maley and Jacquelyn Fradette (Sidley Austin) say that courts and litigants should be very aware of the potential preemption and jurisdiction issues raised by state suits against opioid manufacturers alleging inadequate warnings. Writing in a Washington Legal Foundation Legal Backgrounder, the two say that state tort suits’ claims
Drugs
A 5/15-5/17/17 FDA inspection at Clover Custom Blending, Tampa, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/28 Warning Letter. Specific violations cited in the letter were: * failing to thoroughly investigate any unexplained discrepancy or failure
Drugs
A 5/25-5/31/17 FDA inspection at Keshava Organics, Maharashtra, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients. A 3/15 Warning Letter says the specific deviations were: * failing to adequately investigate out-of-specification results and to implement appropriate corrective actions;
Devices
FDA has cleared a Canon Medical Systems USA 510(k) for a suite of quantitative tools to assess the spectrum of liver disease (including steatosis, inflammation and cirrhosis) on the company’s Aplio i800 ultrasound system. In addition to Shear Wave Elastography imaging, the new suite adds Attenuation Imaging and
FDA Policy/General
Federal Register notice: FDA is requesting nominations for members to serve on its Pharmacy Compounding Advisory Committee, which provides advice on scientific, technical, and medical issues concerning human drug compounding. Nominations received on or before 5/29 will be given first consideration for membership on the committee. To view the
Drugs
A recent inspection of a Cipla drug manufacturing plant in Goa, India has documented significant GMP violations. According to a just-posted Form 483 from a 1/22-25 inspection, the firm failed to thoroughly review out-of specification results and in-process test failures. The inspection also revealed that
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Elemental Impurities in Animal Drug Products — Questions and Answers.” The document is intended to assist sponsors in addressing changes in United States Pharmacopeia requirements for controlling elemental impurities in drug products. It includes recommendations on all dosage forms and
FDA Policy/General
Federal Register notice: FDA has amended a public workshop entitled ‘‘Orthopedic Sensing, Measuring, and Advanced Reporting Technology (SMART) Devices’’ to reflect a change in the start and end times. The public workshop is now scheduled for 4/30, from 8 am to 5:30 pm. To view the notice, click
Drugs
Delaware federal court judge Richard Andrews has granted a Shire motion to dismiss a 2/7/17 Federal Trade Commission (FTC) complaint alleging that the company abused the FDA citizen petition process to prevent generic competition to its Vancocin. FTC said Shire “inundated” FDA with 46 regulatory and court filings
Devices
The Justice Department says Alere will pay the federal government $33.2 million to resolve allegations that it caused hospitals to submit false claims to federal healthcare programs by knowingly selling materially unreliable point-of-care diagnostic testing devices. A government False Claims Act complaint said that between 1/2006
Drugs
The Biotechnology Innovation Organization (BIO) says its members would benefit from more clarity in terms of a specific timeframe for when FDA might make a preliminary non-binding opinion on whether an application meets the criteria for priority review voucher eligibility. “We recommend that the preliminary opinion be conveyed in
Devices
FDA says it has allowed the marketing (de novo process) of the first fully interoperable continuous glucose monitoring system. Dexcom’s G6 integrated continuous glucose monitoring (iCGM) system is intended to determine blood glucose levels in children aged two and older and adults with diabetes, according to an agency news
Drugs
FDA has approved a Novo Nordisk supplemental NDA for Tresiba (insulin degludec injection) 100 U/mL, 200 U/mL to include data from the DEVOTE safety outcomes study. The following data from the study in patients with Type 2 diabetes and atherosclerotic cardiovascular disease (ASCVD) are now included in the
FDA Policy/General
Tamarack is recalling Eclipse Kratom-containing powder products because they have the potential to be contaminated with Salmonella. Affected dietary supplement powder products are packaged in plastic heat sealed pouches or plastic sealed bottles sold in one gram capsules and powder. The recall was initiated after Tamarack was told by
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.” The document describes policies that FDA proposes to use in evaluating bulk drug substances nominated for use in
Drugs
FDA has issued a guidance on “Chronic Obstructive Pulmonary Disease (COPD): Use of the St. George’s Respiratory Questionnaire as a Patient-reported Outcome Assessment Tool.” The document addresses the use of the questionnaire in interventional clinical trials in patients with COPD. Information in the guidance was previously provided in
Devices
FDA has cleared a Bioness 510(k) for the myBioness mobile app for use with its L300 Go System, a functional electrical stimulation system that offers 3D motion detection of gait events and muscle activation using data from a three-axis gyroscope and accelerometer. Bionesss says the mobile app is
Drugs
FDA has cleared a DarioHealth 510(k) for the company’s Lightning-enabled version of its Dario Blood Glucose Monitoring System which enables the use of the Dario app on iPhone 7, 8 and X smart mobile devices. The clearance permits DarioHealth to offer its glucose meter smartphon connectivity with
Drugs
An Illinois federal jury 3/26 found AbbVie liable for injuries to an Oregon man allegedly caused by the company’s testosterone replacement therapy AndroGel. The jury ordered AbbVie to pay Jesse Mitchell $3.2 million in the fourth bellwether trial in federal multidistrict litigation (mdl) 2545 in the Northern
FDA Policy/General
Info Collection Extension for In Vivo Radiopharmaceuticals Regs Federal Register notice: FDA sends for OMB approval an information collection extension for “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring.” 03/23/2018 Antimicrobial Drugs Panel Meeting on Achaogen NDA Federal Register notice: FDA announces a 5/2 Antimicrobial
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring” (OMB Control Number 0910-0409). The regulations require manufacturers of diagnostic radiopharmaceuticals to submit information that demonstrates the safety and effectiveness of a new diagnostic radiopharmaceutical