NIH launches COVID-19 clinical trials network | Mylan recalls daptomycin injection due to particulate matter | 2 COVID-19 tests authorized for emergency use
July 9, 2020
FDLI SmartBrief
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Drugs & Biologics
The NIH announced the launch of a national clinical trials network, dubbed the COVID-19 Prevention Trials Network, to help perform late-stage clinical trials of COVID-19 vaccines and other treatments. A vaccine co-developed by Moderna and the National Institute of Allergy and Infectious Diseases is expected to be tested in the first late-stage trial conducted through COVPN this summer.
Full Story: Regulatory Focus (7/8) 
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India-based Lupin Pharmaceuticals and Granules Pharmaceuticals have recalled their metformin products after the FDA warned that it discovered higher-than-acceptable levels of N-nitrosodimethylamine, a probable human carcinogen, in the drugs. Lupin is pulling all lots of its metformin extended-release tablets, while Granules is recalling 12 lots after discovering higher than allowed levels of NDMA in some batches.
Full Story: Becker's Hospital Review (7/8) 
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Mylan is recalling a single lot of injectable daptomycin after particulate matter was found in a single-dose sample vial manufactured at the firm's specialty formulation center in India. The affected lot was distributed to wholesalers and retail pharmacies across the US from April to May, the FDA said.
Full Story: FiercePharma (7/8) 
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Medical Devices
The FDA has given emergency use authorization to Assure Tech for its Assure COVID-19 IgG/IgM Rapid Test Device, which can deliver results within 15 minutes, and to Laboratorio Clinico Toledo for its Laboratorio Clinico Toledo SARS-CoV-2 Assay.
Full Story: GenomeWeb Daily News (free registration) (7/8) 
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The FDA has given 510(k) clearance to Getinge for its Servo-air mechanical ventilator, a critical care ventilator for adult and pediatric patients that has invasive and noninvasive options for ventilation.
Full Story: FDAnews (7/9) 
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Food & Dietary Supplements
The recently introduced Requiring Assistance to Meat Processors for Upgrading Plants Act -- the RAMP-UP Act -- could provide incentives for facilities to improve their meat processing capacity and focus on a more diversified processing model. The bipartisan bill would provide $100,000 grants to meat processors to become federally inspected and compliant with the USDA's Food Safety & Inspection Service.
Full Story: Feedstuffs (Minnetonka, Minn.) (7/6) 
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Global Focus
China has two COVID-19 vaccines slated to begin late-stage trials later this month, putting the country ahead of others in vaccine development. Eight of the 19 vaccines under development originate from China.
Full Story: Reuters (7/7) 
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European regulators have given CE mark approval to Asuragen for its AmplideX SMA Plus Kit that is used to diagnose spinal muscular atrophy and determine if a person is an asymptomatic carrier.
Full Story: FDAnews (7/8) 
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European regulators have given CE mark approval to DiaSorin Molecular for its Simplexa Flu A/B & RSV Direct Gen II assay, which can be used in combination with the firm's Simplexa COVID-19 Direct assay or by itself to test for influenza and respiratory syncytial virus.
Full Story: GenomeWeb Daily News (free registration) (7/7) 
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Food and Drug Law Institute (FDLI) Highlights
Virtual Happy Hour: Update Magazine Authors Discuss DOJ's Evaluation of Corporate Compliance Programs | July 9, 5:00 PM EDT
Complimentary Member-Only Opportunity
There's still time to register for today's virtual "Author Happy Hour" where we will discuss the article, "The Impact of DOJ's Evaluation of Corporate Compliance Programs on FDA-Regulated Products." Greenleaf Health, Inc. authors Madeleine Giaquinto and Cynthia Schnedar will discuss DOJ's current approach to enforcement, best practices for corporate compliance programs, and quality management principles that apply to FDA-regulated products. This member-only benefit is limited to twenty attendees. Register Now
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