Devices
FDA has cleared a Luminex 510(k) for the Aries MRSA Assay, a real-time, polymerase chain reaction-based, in vitro diagnostic test for detecting methicillin-resistant Staphylococcus aureus (MRSA) DNA from nasal swabs in patients at risk for nasal colonization. The MRSA assay joins the company’s Aries C.
Drugs
FDA says it notified Shanghai Institute of Pharmaceutical Industry of a planned surveillance and pre-approval inspection of its drug product testing facility from 11/29-12/4/18 and the company refused the inspection in a 12/4/18 written response. A just-released 8/29 Warning Letter says
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it applauds FDA for the BEST (Biomarkers, EndpointS, and other Tools) resource taxonomy that serves as a point of consensus for all stakeholders and provides clarity needed to drive programs in biomedical research and clinical care. In a comment letter, PhRMA says
Drugs
FDA has issued a complete response letter to AstraZeneca for its NDA for PT010 (budesonide/glycopyrronium/formoterol fumerate), an inhaled triple-combination therapy for patients with chronic obstructive pulmonary disease. The company says the NDA included data from the KRONOS Phase 3 trial. It says AstraZeneca will now work closely
FDA Policy/General
Federal Register notice: FDA has announced the fee rate of $2,167,116 for using a tropical disease priority review voucher for fiscal year 2020. The vouchers are awarded to the sponsors of certain tropical disease product applications when FDA approves them. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry #261 entitled “Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs.” FDA says that eligibility for conditional approval has been expanded beyond minor uses in major species and minor species to include certain major uses. Expanded conditional
Drugs
FDA and the U.S. Drug Enforcement Administration have issued joint Warning Letters to four online networks that were illegally marketing unapproved and misbranded versions of opioid medicines, including tramadol. The letters ordered the networks to immediately stop illegally selling the opioids to American consumers. Additionally, an FDA notice said
Devices
FDA has cleared a CivaTech Oncology 510(k) for its CivaDerm, a temporary radiation therapy product designed for intraoperative or surface radiation to treat skin cancer and other lesions. The polymer-encapsulated brachytherapy device can be applied like a bandage to provide a low dose rate brachytherapy treatment for skin
Drugs
FDA has posted an 11-item Form FDA-483 to U.S. Specialty Formulations after concluding an inspection in July of its Bethlehem, PA manufacturing facility. According to the form, FDA cited it for not having written procedures for production and process controls. It also found that results of stability
Devices
A new and comprehensive FDA literature review on dental amalgam safety did not find sufficient evidence of a relationship between clinically detectable adverse health outcomes and dental amalgam mercury exposure. Nevertheless, FDA says it will refer the review for discussion at a previously scheduled advisory committee meeting 11/13-14
Drugs
Federal Register notice: FDA has announced the fee rate of $2,167,116 for using a rare pediatric disease priority review voucher for fiscal year 2020. The vouchers are awarded to the sponsors of rare pediatric disease product applications when FDA approves them. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced the fee rate of $2,167,116 for using material threat medical countermeasure (MCM) priority review voucher for fiscal year 2020. The vouchers are awarded to the sponsors of material threat MCM applications upon FDA approval. To view the notice, click here.
Drugs
The government has charged Avanir Pharmaceuticals and four individuals with paying kickbacks to a physician to induce prescribing of its drug Nuedexta (dextromethorphan hydrobromide and quinidine sulfate), which is indicated for treating pseudobulbar affect (PBA), according to the U.S. Department of Justice. “Avanir has also agreed to pay over
Drugs
FDA has made available a draft guidance on “Patient-Focused Drug Development: Methods to Identify What Is Important to Patients.” The document describes how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers to be used
FDA Policy/General
Guide on Device Software Policy Changes Federal Register notice: FDA makes available a final guidance on “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.” 09/27/2019 Guide on Type A Medicated Articles Federal Register notice: FDA makes available a draft guide
FDA Policy/General
BIOLOGICS Protein Sciences has received expanded approval from FDA for Flublok influenza vaccine to treat adults aged 18 years and older. The company says the vaccine is developed using modern recombinant technology, and is the only flu vaccine that is 100% egg-free and highly purified. It adds that the
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for industry #171 entitled “Demonstrating Bioequivalence for Soluble Powder Oral Dosage Form Products and Type A Medicated Articles Manufactured from Active Pharmaceutical Ingredients Considered to be Soluble in Aqueous Media.” The document describes how the agency intends to evaluate requests
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Clinical Decision Support Software.” The document clarifies the types of clinical decision support (CDS) functions that do not meet the definition of a device as amended by the 21st Century Cures Act. It describes a risk-based approach for
Drugs
FDA says it has awarded a new five-year contract to enhance its Sentinel System and prepare it for managing real-world data to improve the safety and effectiveness of drugs. The contract, which was awarded to two consortiums led by Harvard Pilgrim Health Care and Deloitte Consulting, will create
Drugs
FDA has approved Genentech’s Rituxan (rituximab) injection to treat granulomatosis with polyangiitis and microscopic polyangiitis in children two years of age and older in combination with glucocorticoids. An FDA release says it is the first approved treatment for children with these rare vasculitis diseases, in which a patient’s
FDA Policy/General
An email distribution by Galt Pharmaceuticals to health professionals has drawn an FDA Warning Letter on insomnia drug Doral (quazepam) tablets because it made misleading claims and representations about the drug’s risks. The CDER Office of Prescription Drug Promotion (OPDP) letter charged that the Doral email included numerous claims
FDA Policy/General
Federal Register notice: FDA has made available a final guidance on “Changes to Existing Medical Software Policies Resulting From Section 3060 of the 21st Century Cures Act.” The guidance provides the agency’s current thinking on changes made by the act to the definition of a medical device and the