Biologics
FDA commissioner Stephen Hahn says that CDER director Janet Woodcock and CBER director Peter Marks will recuse themselves “from the supervisory chain of command in matters related to product review decisions for applications related to the areas that they are advancing that have a nexus to Covid-19.” Hahn issued
FDA Policy/General
Federal Register notice: FDA is announcing a 6/4-5 public Web conference to discuss the International Council for Harmonization’s (ICH's) good clinical practice guidelines. The conference, “Stakeholder Engagement on ICH E6:Guideline for Good Clinical Practice,” is intended to capture stakeholder experiences with current ICH E6
Drugs
Karyopharm Therapeutics has submitted a supplemental NDA for Xpovio (selinexor), its first-in-class, oral selective inhibitor of nuclear export compound, as a new treatment for patients with previously treated multiple myeloma. The submission is based on data from the pivotal Phase 3 BOSTON study evaluating the combination of Xpovio
Devices
The American Hospital Association, Association of periOperative Registered Nurses, and AdvaMed have issued a document with reentry guidance for healthcare facilities and medical device representatives. “The following principles are intended to guide facilities, healthcare personnel, and medical device representatives as they adopt access policies that support safe reentry of medical
Drugs
FDA says it has agreed with Aetion to collaborate on advanced analytical techniques to answer urgent Covid-19 research questions. Aetion says it has developed “scientifically validated software for performing rapid analyses to generate real-world evidence at scale.” An online statement from principal deputy commissioner Amy Abernathy says FDA
Drugs
An 11/11-11/14/19 FDA inspection at Kumar Organic Products, Gujarat, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 4/23 Warning Letter says specific violations were: * failing to use equipment in the manufacture, processing, packing, or holding of
Drugs
The Association for Accessible Medicines (AAM) says FDA should implement the REMS (Risk Evaluation and Management Strategy) requirements for drugs approved under ANDAs. Commenting on an agency draft guidance on the development of a shared system risk evaluation and mitigation strategy, AAM says that as a result of recent changes
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says that an FDA draft guidance on best practices in drug and biological product postmarket safety surveillance for FDA staff “is an important step in FDA’s continuous efforts to enhance the efficiency of postmarket drug safety surveillance practices for drugs, biologics, combination
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Blaine Labs, Santa Fe Springs, CA (5/5): FDA inspected the firm 9/2019 and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to thoroughly
Drugs
FDA has accepted for accelerated review an Eiger BioPharmaceuticals NDA for Zokinvy (lonafarnib) for treating Progeria and Progeroid Laminopathies. The agency set a user fee review action target date of 11/20, and Eiger says it was told that an advisory committee meeting to discuss the application is not being
Drugs
The HHS Biomedical Advanced Research and Development Authority has awarded an initial $354 million contract to Phlow, a Richmond, VA, drug manufacturing company, for advanced manufacturing of America’s most essential medicines at risk of shortage, including medicines for the Covid-19 pandemic response. The total contract value over 10
Drugs
FDA has announced a 6/9-10 Web cast entitled “Pharmacovigilance and Risk Management Conference — New Approaches, Tools, and Technologies.” An agency notice describes the training as being designed to provide participants with a “foundation in regulations, FDA guidances, and risk-based principles aimed at ensuring safety of marketed drug
Devices
FDA has cleared a Zebra Medical Vision 510(k) for its Vertebral Compression Fractures an artificial intelligence product that the company says automatically identifies findings suggestive of compression fractures to help clinicians to determine if patients are at risk of osteoporosis. Zebra says its algorithm is designed to detect vertebral
Devices
A 2/3-2/12 FDA inspection at Lymol Medical, Woburn, MA, found Quality System Regulation violations in the firm’s manufacturing of Elite X Class rigid bronchoscope systems and Premier S Class silicone stents. A just-released 4/7 Warning Letter says specific violations were: * failing to validate according
Devices
FDA has granted an emergency use authorization (EUA) for Everlywell’s at-home sample collection kit that can then be sent to specified laboratories for Covid-19 diagnostic testing. The Everlywell Covid-19 Test Home Collection Kit is authorized to be used by individuals at home to collect a nasal
FDA Policy/General
Federal Register notice: FDA has issued a final guidance on “Covid-19: Developing Drugs and Biological Products for Treatment or Prevention.” The document describes the agency’s current recommendations regarding Phase 2 or Phase 3 trials for drugs or biological products under development for treating or preventing Covid-19. It
Drugs
Teva Pharmaceutical Industries reportedly has abandoned settlement talks with the U.S. Justice Department’s antitrust division over an ongoing generic drug price-fixing investigation. If the probe reaches a criminal indictment against Teva, the company could face a large financial penalty and possible restrictions under Medicare, according to a
Drugs
FDA has granted accelerated approval for a Clovis Oncology NDA for Rubraca (rucaparib) for patients with deleterious BRCA-mutated (germline or somatic) metastatic castration-resistant prostate cancer (mCRPC) who have been treated with an androgen receptor-directed therapy and a taxane-based chemotherapy. Approval was based on data from an
Drugs
Adamis Pharmaceuticals has resubmitted an NDA for Zimhi (naloxone HCI injection) for treating opioid overdose. The resubmission addresses an 11/2019 complete response letter that cited Chemistry, Manufacturing and Controls (CMC) information (see earlier story), according to the company. When the letter was issued, Adamis said it planned to expand
Drugs
President Trump told reporters at the White House 5/18 that he has been taking the controversial malaria drug hydroxychloroquine to prevent coronavirus. “I’ve been taking it for about a week and a half now and I’m still here,” he said. Last month, FDA issued a MedWatch safety
Devices
FDA has issued an alert about preliminary data from New York University researchers suggesting potential inaccurate results (false negatives) from Abbott’s ID NOW point-of-care test used to diagnose Covid-19. Abbott’s test is frequently used at the White House to test visitors before entering the Oval
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision for “General Administrative Practice and Procedures” (OMB Control Number 0910-0191). The collection is being revised to consolidate related activities discussed in agency guidance to improve the efficiency of its operations. To view the notice, click here.