FDA Policy/General
President Donald Trump reportedly will nominate University of Texas MD Anderson Cancer Center chief medical executive Stephen Hahn to be FDA commissioner. BioCentury says sources familiar with the decision informed it of the choice. The nomination reportedly would be announced following completion of FBI background checks. Hahn is said to
Drugs
FDA says it is continuing to test ranitidine products (see earlier story) from multiple manufacturers and is assessing the potential impact on patients who have been taking the product that has been found to contain a nitrosamine impurity called N-nitrosodimethylamine (NDMA). In addition, the agency has asked ranitidine manufacturers
Biologics
FDA has made available a final guidance entitled Further Testing of Donations that are Reactive on a Licensed Donor Screening Test for Antibodies to Hepatitis C Virus. The document provides recommendations and asserts that each donation found to be reactive must be further tested using a licensed, approved or cleared
Drugs
FDA has published a guidance, Investigational Enzyme Replacement Therapy Products: Nonclinical Assessment, to help sponsors develop and conduct nonclinical studies during development of investigational enzyme replacement therapy (ERT) products. Specifically, the document describes the agency’s current thinking about the substance and scope of nonclinical information needed to support start
Devices
FDA has cleared a Turner Imaging Systems 510(k) for its Smart-C Mini-C Arm Portable Fluoroscopy and X-Ray Imaging Device. What makes this device unique is its true mobility and portability. The device weighs 16 pounds, allowing it to be hand-carried to the point of care.
Drugs
GlaxoSmithKline and Innoviva have submitted a supplemental NDA seeking an additional indication for once-daily use of Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for treating asthma in adults. Trelegy Ellipta was originally approved 9/2017 for treating patients with chronic obstructive pulmonary disease (COPD). The submission is based on data
Drugs
Johnson & Johnson has agreed to pay $20.4 million to resolve claims by two Ohio counties relating to the company’s role in promoting opioid use. Reuters reports that J&J will pay $10 million to Cuyahoga and Summit counties, reimburse $5 million of their legal and other
Devices
The International Medical Device Regulators Forum has issued a draft guidance, Principles and Practices for Medical Device Cybersecurity, “to provide fundamental concepts and considerations on the general principles and best practices to facilitate international regulatory convergence on medical device cybersecurity.” The document is intended to provide concrete recommendations to all
Drugs
The National Institutes of Health (NIH) has awarded $29 million to fund five additional hubs to speed the translation of biomedical discoveries into commercially viable diagnostics, devices, therapeutics, and tools to improve patient care and enhance health. The newly selected Research Evaluation and Commercialization Hubs expand a national network of
Drugs
FDA has accepted for priority review a Merck NDA for Dificid (fidaxomicin) for oral suspension, and a supplemental NDA for a new indication for Dificid tablets and oral suspension for treating Clostridium (also known as Clostridioides) difficile infections in children aged six months or older. The macrolide antibacterial is currently
Drugs
FDA has approved a Puma Biotechnology labeling supplement for Nerlynx (neratinib) for the extended adjuvant treatment of HER2-positive early stage breast cancer. The label now includes safety information that is based on interim results from Puma’s Phase 2 CONTROL trial, a study evaluating dose escalation in reducing neratinib-
FDA Policy/General
Federal Register notice: FDA has determined that 24 drug products were not withdrawn due to safety or effectiveness reasons. The determination permits FDA to approve ANDAs that reference the products as long as they meet relevant legal and regulatory requirements. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA announced a 11/13-14 Immunology Devices Panel of the Medical Devices Advisory Committee meeting to discuss immunological responses related to metal-containing products regulated as medical devices. The discussion will focus on metal-containing implants as well as dental amalgam. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.” The document describes how to collect and submit information from patients and caregivers to be used for medical product development and regulatory decision-making. To view the
Drugs
A 3/25-3/29 FDA inspection at Dermameal Co., Gunpo-si Gyeonggi-do, South Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 9/12 Warning Letter says specific violations were: * failing to establish an adequate quality control unit with the responsibility and
Drugs
FDA has awarded a contract that may reach $220 million over the next five years to Harvard Pilgrim Health Care Institute to lead the Sentinel Operations Center and develop a new Sentinel Innovation Center. Harvard Pilgrim says the contract builds on its 10 years of experience developing and operating the
Devices
FDA is informing patients, healthcare professionals, IT staff in healthcare facilities, and manufacturers about the Urgent/11 cybersecurity vulnerabilities that, if exploited by a remote attacker, “may introduce risks for medical devices and hospital networks.” An online notice says that Urgent/11 affects several operating systems that may then affect
Drugs
Endo says it is voluntarily withdrawing its 10/2017 suit against FDA challenging the agency’s interim policy authorizing bulk compounding of drugs that relied on enforcement discretion to allow bulk compounding of vasopressin, the active ingredient in Vasostrict, manufactured by Endo’s Par Sterile Products subsidiary. Endo says the
Drugs
An 11/26-12/4/18 FDA inspection at Lupin Limited Unit 1, Madhya Pradesh, India, found significant violations of current good manufacturing practice (CGMP) for finished pharmaceuticals and significant deviations from CGMP for active pharmaceutical ingredients. A 9/10 Warning Letter says the agency has found similar CGMP violations
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Lupin Limited, Madhya Pradesh, India (9/10): FDA inspected the firm 12/2018 and cited significant GMP violations for finished pharmaceuticals and active pharmaceutical ingredients (API). For example, Lupin
Drugs
Heron Therapeutics has resubmitted an NDA for HTX-011, an investigational agent for managing postoperative pain. The company expects a six-month review by the agency. The NDA was resubmitted based on feedback from an FDA/company meeting that sought clarity on an April complete response letter which requested additional
FDA Policy/General
Former FDA commissioner Robert Califf has accepted a full-time role at Alphabet Company as the head of medical strategy and policy for Google Health and Verily Life Sciences units. Califf left FDA 1/2017 after president Trump took office and returned to Duke University as vice chancellor for data