Drugs
FDA has granted fast track status to Calithera Biosciences for CB-839 and its use in combination with cabozantinib for treating patients with metastatic renal cell carcinoma who have received one or two prior lines of therapy, including at least one vascular endothelial growth factor tyrosine kinase inhibitor or the
Drugs
Speaking 4/17 at the National Policy and Advocacy Summit on Biologics and Biosimilars, CDER Office of New Drugs associate director Leah Christl said that over time the U.S. will see a dramatic increase in the number of biosimilar approvals, based on the quantity of applications that the agency
Drugs
FDA says a draft guidance, Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products—Quality Considerations, is available. A 4/19 Federal Register notice says the guidance’s purpose is to provide recommendations to industry in the development and manufacture of inhalation aerosols. The draft describes points to
Drugs
A 7/24-7/26/17 FDA inspection at McCallum Manufacturing, South Yorkshire, UK, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 4/9 Warning Letter. Specific violations cited in the letter were: * failing to have, for each batch of drug product,
Devices
FDA has approved a Sientra PMA supplement allowing commercialization of its Opus-branded breast implant products manufactured by Vesta, a Lubrizol LifeSciences company, at Vesta’s Wisconsin-based manufacturing facility. The devices are being made under “an improved manufacturing process,” according to Sientra. “We will continue our precision-controlled selling
Devices
A coalition of 50 environmental, public health, and children’s rights groups is calling on FDA to “bring its policies FDA in line with the federal government as a whole” and to “publicly advise a phase down of the use of mercury amalgams with the goal of phasing out entirely”
Biologics
Reacting to an incident in which a south Florida clinic performed unproven stem cell treatments that left three female patients blind, Sen. Charles Grassley (R-IA) has asked HHS and FDA for additional information. Grassley’s letter to the agencies cited a Washington Post report indicating that the three women
Drugs
FDA medical reviewers say three clinical trials conducted by GW Pharma “provide substantial evidence of the effectiveness of CBD (cannabidiol) for the treatment of seizures associated with Lennox-Gestaut syndrome (LGS) and Dravet syndrome (DS) in patients two years of age and older.” The assessment is included in a briefing
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices; Guidance for Industry and Food and Drug Administration Staff.” The document clarifies FDA’s policy on compliance with applicable performance standards and conformance to International Electrotechnical Commission (IEC)
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.” The document describes an optional streamlined submission process to determine whether an investigational in vitro diagnostic in an oncology clinical trial under an IND (an
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Special Protocol Assessment (SPA)” that provides information about the procedures and general policies adopted by CDER/CBER for such assessments. It is intended to improve the quality of requests for SPAs and accompanying submission materials, and the interactions between sponsors
Devices
FDA has released a new Medical Device Safety Action Plan outlining a vision for how the agency can continue to enhance its programs and processes to assure medical device safety. The plan reorganizes what has long been the agency’s most troubled Center. FDA commissioner Scott Gottlieb says the agency
Drugs
A 9/25-9/28/17 FDA inspection at Luen Wah Medicines, Hong Kong, found significant violations of current good manufacturing practice regulations (CGMP) for finished pharmaceuticals, according to a 4/6 Warning Letter. Specific violations cited in the letter were: * failing to perform, for each batch of drug product,
Devices
An 8/14-8/18/17 FDA inspection at SynCardia Systems, Tucson, AZ, found Medical Device Reporting violations associated with the firm’s manufacturing of the SynCardia Total Artificial Heart System, according to a 4/3 Warning Letter. Specific violations cited in the letter were: * failing to report to FDA
Drugs
A bipartisan group of four senators has introduced legislation they say will help bring non-opioid or non-addictive pain medications and treatments for substance abuse disorders to patients more quickly. The bill was introduced by Sens. Orrin Hatch (R-UT), Michael Bennet (D-CO), Joe Donnelly (D-IN) and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Hanbul Cosmetics Co. Republic of Korea (3/29): FDA inspected the firm 11/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm could not provide
Drugs
FDA has approved an Ultragenyx Pharmaceutical NDA for Crysvita (burosumab), the first drug approved to treat adults and children ages one year and older with x-linked hypophosphatemia. The rare, inherited form of rickets causes low levels of phosphorus in the blood, and it leads to impaired bone growth and
Devices
FDA has approved an Abbott firmware update for its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds) due to battery and cybersecurity concerns. The corrective action (recall) is intended to “reduce the risk of patient harm due to premature battery depletion and potential exploitation of cybersecurity vulnerabilities
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Highly Concentrated Caffeine in Dietary Supplements.” FDA considers some dietary supplements that consist of only or primarily pure or highly concentrated caffeine to be adulterated, and the document outlines the agency’s current thinking on such products. It is intended
Drugs
FDA says it has qualified the use of a patient-reported outcome instrument for exploratory use to measure symptoms of non-small cell lung cancer. Before using the “Qualification of Non-Small Cell Lung Cancer Symptom Assessment Questionnaire,” the agency recommends that sponsors should engage the review division early and
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Permanent Discontinuation or Interruption in Manufacturing of Certain Drug and Biological Products 21 CFR 310.306, 314.81(b)(3)(iii), and 600.82” (OMB Control Number 0910-0759). Agency regulations require application holders to notify FDA
Drugs
FDA has released a draft guidance for industry entitled “Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.” The document, which was developed by the agency’s Oncology Center of Excellence, CDER, CBER and CDRH. It describes an optional streamlined submission process for determining whether