Drugs
FDA has published a draft guidance, Annual Status Report Information and Other Submissions for Postmarketing Requirements and Commitments: Using Forms FDA 3988 and 3989, for use by applicants who are required by statute or regulation, or that have agreed in writing, to conduct post-marketing studies or clinical trials concerning
Drugs
FDA Oncology Center of Excellence director Richard Pazdur and two other FDAers say the agency has worked to support ongoing cancer treatment research that has been challenged during the Covid-19 pandemic. Writing in a JAMA Oncology viewpoint column, the three say the agency “sought to proactively address concerns about
Biologics
California Gov. Gavin Newsom has formed a Scientific Safety Review Workgroup with 11 acclaimed physician-scientists living in the state to independently review the safety and efficacy of any Covid-19 vaccine that FDA approves for distribution. Newsom says the panelists will review any vaccine that receives federal approval and
Drugs
FDA has accepted an AstraZeneca sNDA for Tagrisso (osimertinib) and will give it priority review for adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent. A company statement says the sNDA was based on results
Devices
FDA has cleared an Ezra 510(k) for its artificial intelligence (AI) and its use in assisting radiologists in their analysis of prostate MRI scans. The device is intended to provide accurate prostate volume measurements, semi-automatic lesion measurements, and automatic prostate and lesion segmentation and 3D volume representation. Should
Devices
FDA’s Medical Device Development Tools program has listed an agency-qualified tool that medical device sponsors can use in developing and evaluating medical devices that pose a cybersecurity concern. The tool is a rubric for applying a common vulnerability scoring system to medical devices. FDA says the rubric is
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Medoz Pharmacy of Polk, Davenport, FL (9/25): FDA inspected the firm in August and cited serious deficiencies in its practices for producing sterile drug products. For example, the
FDA Policy/General
Spurred by the Covid-19 emergency, FDA says it is speeding up the implementation of a software-defined network and adoption of other design approaches that make the transition to cloud-based technologies faster and more secure. This work is spearheaded by the agency’s Technology Modernization Action Plan (TMAP)
Devices
FDA is seeking feedback on a discussion paper entitled Communicating Cybersecurity Vulnerabilities to Patients: Considerations for a Framework. The paper provides best practices to consider when communicating with patients and caregivers about cybersecurity vulnerabilities. Feedback on the discussion paper, according to the agency, will help inform future efforts designed to
FDA Policy/General
At the request of several Democrat senators, the Government Accountability Office (GAO) has agreed to conduct an investigation of the Trump Administration’s alleged political interference at FDA and the Centers for Disease Control and Prevention (CDC) to determine whether the interference has violated the agencies’ scientific integrity and communication
FDA Policy/General
Federal Register notice: FDA is announcing the Web site location where it will post two lists outlining guidance documents that CDRH intends to publish in fiscal year 2021. In addition, FDA has established a docket where interested parties may comment on the guidance topic priorities, provide comments or propose draft
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in selecting nonvoting industry representatives to serve on certain Medical Devices Advisory Committee panels notify FDA in writing. FDA is also requesting nominations for nonvoting industry representatives to serve on certain device panels. To view the notice,
Devices
FDA has cleared an Ossio 510(k) for its Ossiofiber Compression Screw Portfolio for alignment maintenance and fixation of bone fractures, comminuted fractures, fragments, osteotomies, arthrodesis and bone grafts of the upper extremity, fibula, knee, ankle and foot. The devices comprise a 4.0mm-diameter cannulated, headless, partially threaded compression
Drugs
FDA has granted full approval for AbbVie and Roche’s Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine for treating newly diagnosed acute myeloid leukemia in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was granted an
FDA Policy/General
Info Request on Combo Product Designations Federal Register notice: FDA seeks comments on an information collection extension related to its guidance entitled “Combination Products: How to Write a Pre-Request For Designation (RFD).” 10/16/2020 Modified Device Consensus Standards Listing Federal Register notice: FDA modifies the list of standards
FDA Policy/General
Federal Register notice: FDA has reopened the comment period for a 6/1 notice entitled “Listing of Patent Information in the Orange Book; Establishment of a Public Docket; Request for Comments.” Electronic or written comments can now be submitted by 11/16. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available three guidance documents related to the Covid–19 public health emergency. The guidances have been implemented without prior comment, but they remain subject to comment under the agency’s good guidance practices. They are: * Manufacturing, Supply Chain, and Drug and Biological Product Inspections
FDA Policy/General
Federal Register notice: FDA makes available a final guidance entitled Testing for Biotin Interference in In Vitro Diagnostic Devices. The document provides recommendations on testing for interference by biotin on the performance of in vitro diagnostic devices (IVDs). It is intended to help device developers and clinicians understand how the
FDA Policy/General
The northern Texas federal court has sentenced two former dietary supplement company executives to prison and ordered two companies to pay a combined $10.7 million in criminal forfeiture for their roles in fraudulently selling popular workout supplements. Former USPlabs CEO Jacobo Geissler (University Park, TX) was sentenced to 60
Biologics
Pfizer CEO Albert Bourla says the company and its development partner BioNTech should be able to tell that their Covid-19 vaccine is effective by the end of the month, and an emergency use authorization (EUA) request could be filed as early as the third week of November. In a
FDA Policy/General
FDA is evaluating whether it can use live or recorded video to conduct medical product inspections as the Covid-19 pandemic continues to disrupt the agency in its inspection duties. Early in the pandemic, FDA suspended both domestic and foreign inspections, and in late July domestic inspections resumed on a
FDA Policy/General
Federal Register notice: FDA is announcing a “Quality Management Maturity for Active Pharmaceutical Ingredients Pilot Program” for foreign facilities manufacturing active pharmaceutical ingredients (APIs) that are used in FDA-regulated prescription and over-the-counter drug products. The purpose of the pilot is to gain insight from third-party assessments