Devices
FDA has issued a “not approvable” letter to PneumRx for its PMA application for Elevair Endobronchial Coil System for treating people with severe emphysema. On 6/14, FDA’s Anesthesiology and Respiratory Therapy Devices Panel of the Medical Devices Advisory Committee voted 7 to 5 in favor of the device’
Drugs
The FDA Antimicrobial Drug Advisory Committee has voted to recommend to the agency that Paratek Pharmaceuticals’ intravenous and oral omadacycline is safe and effective for treating acute bacterial skin and skin structure infections and treating community-acquired bacterial pneumonia. Omadacycline is described as a modernized tetracycline being developed as a
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of four NDAs from multiple applicants after they told the agency that the products were no longer marketed and requested they be at withdrawn. To view the notice, click here.
Drugs
Federal Register notice: FDA has made available a final guidance entitled “Elemental Impurities in Drug Products.” The document provides recommendations on controlling elemental impurities consistent with recommendations in an International Council for Harmonization guidance for industry entitled “Q3D Elemental Impurities.” It is also intended to assist manufacturers on complying with
Drugs
The Stericycle Recall Index says that pharmaceutical recalls dropped 27% to 77 in the second quarter of 2018. That was lower than in six of the last eight quarters. Recalled units dropped 95% to nearly 15.9 million, lower than four of the last six quarters, the report says, but
Drugs
Insys Therapeutics has reached an agreement in principle with the Department of Justice to pay $150 million to settle a civil and criminal investigation into inappropriate sales and commercial practices by some former company employees. The agreement calls for Insys to pay the fine over five years, with the potential
Devices
FDA has cleared an iCAD 510(k) for its latest artificial intelligence software solution — PowerLook Density Assessment Version 3.4. The software is compatible with iCAD’s digital breast tomosynthesis platform on both GE and Hologic systems. “Breast density plays a critical role in both risk assessment and accuracy, as
Drugs
Texas attorney general Ken Paxton says that AstraZeneca has agreed to pay the state $110 million to settle suits alleging that the company falsely and misleadingly marketed Seroquel and Crestor in violation of the Texas Medicaid Fraud Prevention Act. In a statement, Paxton says the company was accused of engaging
Drugs
FDA has issued a guidance, Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances, to give manufacturers recommendations for submission of NDAs, INDs, or ANDAs, as appropriate, for orally administered immediate-release drug products that contain highly soluble drug substances.
Drugs
FDA has used its new Competitive Generic Therapy (CGT) designation to approve several strengths of Apotex’ potassium chloride oral solution. An agency statement says the CGT pathway was created to expedite the development and review of a generic drug for products that lack competition. Potassium chloride is an oral treatment
Devices
FDA is reminding healthcare providers that tests to detect ruptures of the amniotic membranes should not be used without other clinical assessments to make critical patient management decisions. An agency letter says that healthcare providers using rupture of membranes (ROM) tests should be aware of the test limitations shown in
Devices
Qiagen Sciences has recalled the AmniSure ROM Test due to a potential manufacturing defect causing the control line to not display. “A lack of a control line may lead to misinterpretation of test results,” a recall notice says. “The test is designed to display one line (control line) if the
FDA Policy/General
Federal Register notice: FDA is withdrawing 27 ANDAs from multiple applicants after the application holders told the agency that the drug products were no longer marketed and requested that they be withdrawn. To view the notice, click here.
Drugs
A 9/25-9/27/17 inspection at Les Produits Chimiques, Quebec, Canada, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API). A 7/24 Warning Letter says specific deviations were: * failing to perform laboratory testing of API to ensure conformance to specifications and to
Devices
AdvaMed says that a provision in an FDA Q-Submission Program draft guidance extending from 21 to 70 days the agency’s feedback timeline for submission issue requests (SIRs) received after the 30-day deadline after a marketing submission hold “risks counterproductive results.” In its comment letter, AdvaMed says that
Drugs
FDA has released the FDA-483 issued following a 7/9-7/17 inspection at Celltrion, an Incheon, Republic of Korea, sterile injectable drug product and drug substance manufacturer. The inspection observations were: * failing to have written procedures for production and process controls designed to assure that the drug products
Drugs
FDA has accepted for review a Glenmark Pharmaceuticals NDA for Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), an investigational fixed-dose combination antihistamine/steroid nasal spray for treating seasonal allergic rhinitis in patients 12 years of age and older. The submission includes efficacy and safety results from
Devices
CBER says the Web site testkitmart.com is promoting two HIV tests — the iCare HIV 1&2 Rapid Screen Test and the iCare One-Step HIV 1/2 Oral Fluid Test — in the U.S. when the tests are not approved for sale here and have not received IDE
FDA Policy/General
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Les Produits Chimiques B.G.R., Quebec, Canada (7/24): FDA inspected the firm 9/2017 and cited significant GMP deviations for
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Reclassification Petitions for Medical Devices” (OMB Control Number 0910-0138). Agency regulations give it the responsibility to collect data and information contained in such petitions, which allow any person to petition for reclassification of a device from
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment.” The document addresses acceptable clinical endpoints for such drugs. The agency is also requesting comments on when the use of placebo or active controls is most
Drugs
FDA has approved an expanded use for Vertex Pharmaceuticals’ Orkambi (lumacaftor/ivacaftor) to include use in children ages two through five years with cystic fibrosis (CF) who have two copies of the F508del-CFTR mutation, making it the first therapy approved to treat the underlying cause of CF in this