Drugs
FDA was briefly mentioned in president Trump’s 10/26 speech declaring the opioid abuse crisis in the U.S. to be a public health emergency. “The FDA is now requiring drug companies that manufacture prescription opioids to provide more training to prescribers and to help prevent abuse and addiction
Drugs
FDA has accepted for review a Genentech supplemental BLA for Avastin (bevacizumab) for its use in combination with chemotherapy (carboplatin and paclitaxel), followed by Avastin alone, for the front-line treatment of women with advanced ovarian cancer. The agency has set a user fee review action target date of 6/
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Breakthrough Devices Program; Draft Guidance for Industry and Food and Drug Administration Staff” that describes policies the agency intends to use to implement the new Breakthrough Devices Program, which was established by the 21st Century Cures Act. The program
Drugs
“Your firm manufactures drug products in a kitchen,” complains a 10/13 nine-page FDA Warning Letter to Ridge Properties owner John Randall Durig in a Salem, OR trailer park. “You use household kitchen utensils and cookware, including a steel pot, blender, and kitchen spatula to mix ingredients. Our investigator
Drugs
FDA has released two draft guidances that together describe a systematic, risk-based approach to evaluating drug-drug interactions (DDIs) and communicating the results of DDI studies. The first guidance, Clinical Drug Interaction Studies—Study Design, Data Analysis, and Clinical Implications, is to help sponsors of investigational NDAs and applicants
FDA Policy/General
Federal Register notice: FDA has made available two draft guidances entitled “In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies” and “Clinical Drug Interaction Studies — Study Design, Data Analysis, and Clinical Implications.” The guidances update and replace a 2012 revised draft guidance entitled “Drug Interaction Studies — Study Design, Data
Drugs
FDA has approved an Alexion Pharmaceuticals supplemental BLA for Soliris (eculizumab) as a treatment for adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive. Soliris is described as a first-in-class terminal complement inhibitor, and is approved in the U.S. for treating
Drugs
Three staff members in the FDA Oncology Center of Excellence say that advances in health information technologies and a dramatic increase in the adoption of electronic health records “have created new opportunities for optimizing and streamlining clinical evidence generation through collection of real-world data.” Writing in the Journal of
Drugs
A Washington Legal Foundation (WLF) Legal Pulse column written by WLF chief counsel Richard Samp says an 8/21/17 Third Circuit Court of Appeals decision in a case involving Pfizer’s Lipitor may make it “virtually impossible for drug companies to settle patent infringement litigation,” if it is allowed
FDA Policy/General
A U.S. Chamber Institute for Legal Reform report says there is mounting evidence that misleading information and exaggerated claims made in lawsuit ads prevent people from seeking treatment or lead them to stop taking a prescribed medication without consulting a doctor. The report, Bad For Your Health: Lawsuit Advertising
Devices
FDA has cleared a RadiaDyne 510(k) for two new indications for its OARtrac radiation dose monitoring platform. With the added indications, RadiaDyne says physicians can now use the device to routinely monitor brachytherapy radiation dose in certain anatomies, as well as reuse the proprietary OARtrac PSD (Plastic Scintillating Detector)
Drugs
In testimony before the House Energy and Commerce Committee, FDA commissioner Scott Gottlieb says the agency is focusing on three broad areas to help address the opioid crisis — lowering overall exposure to opioid drugs and, in turn, reducing the number of new cases of addiction; enabling more opportunities for those
Drugs
FDA has issued PTC Therapeutics a complete response letter for its NDA for ataluren for treating nonsense mutation dystrophinopathies. The agency letter “indicated that evidence of effectiveness from an additional adequate and well-controlled clinical trial(s) will be necessary at a minimum to provide substantial evidence of effectiveness,” the
Drugs
FDA has issued Antares Pharma a complete response letter on its NDA for Xyosted (testosterone enanthate) injection for testosterone replacement therapy. The letter identified two deficiencies related to clinical data, according to the company. “Based on findings in studies QST-13-003 and QST-15-005, the FDA is concerned
FDA Policy/General
Federal Register notice: FDA has determined that HRA Pharma’s Ovrette (norgestrel) tablets, 0.075 mg, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve ANDAs referencing the product if all other legal and regulatory requirements are met. The FDA action
Devices
OriGen Biomedical has recalled two lots of its Reinforced Dual Lumen catheter due to a separation risk involving the clear extension tube from the hub connection. “If separation occurs, it can result in serious adverse health consequences such as blood loss, prolonged hypotension, low cardiac output, and/or cardiopulmonary arrest,
FDA Policy/General
Federal Register notice: FDA has classified zinc transporter 8 autoantibody immunological test systems into Class 2 (special controls). The classification decision was requested in a 2014 de novo request by Kronus Market Development Associates for its Kronus Zinc Transporter 8 Autoantibody ELISA Assay. The agency identifies the classification as a
Drugs
A 4/3-4/6 FDA inspection at Vital Laboratories Private Limited, Gujarat, India, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients, according to a 10/10 Warning Letter. Specific deviations cited in the letter were: * failing to ensure all production deviations are reported and
Drugs
FDA commissioner Scott Gottlieb and CDER associate director for therapeutic biologics Leah Christi say the agency is launching an educational campaign to inform doctors and other prescribers about biosimilars. In an FDA Voice blog post, Gottlieb and Christi say the agency researched to determine the specific areas that healthcare providers
Devices
A 3/27-3/30 FDA inspection at the ELITech Group facility in Spankeren, The Netherlands, found Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of the Selectra Pro S, Selectra Pro M, and Viva Junior analyzer devices. Specific violations cited in a just-released
FDA Policy/General
Federal Register notice: FDA has classified the mass spectrometer system for clinical use in identifying microorganisms into Class II (special controls). The action was taken in response to a 1/2013 de novo request from bioMérieux for its Vitek MS as a qualitative in vitro diagnostic device intended for
Devices
A 10/24-10/28/16 FDA inspection at DRG Instruments, Marburg, Germany, found Quality System Regulation violations in the firm’s manufacturing of 17-alpha-OH Progesterone ELISA, Salivary Cortisol ELISA, Estradiol ELISA, Salivary Testosterone ELISA, and Testosterone ELISA. Specific violations noted in a 9/19 Warning Letter were: