Mallinckrodt seeks Chapter 11 protection | J&J halts trials of COVID-19 vaccine | US reserves 100K doses of AZ's COVID-19 antibody drug
October 13, 2020
FDLI SmartBrief
News for the food and drug law communitySIGN UP ⋅   SHARE
Drugs & Biologics
Mallinckrodt has filed for Chapter 11 bankruptcy protection after announcing a proposed $1.6 billion settlement to resolve opioid-related lawsuits. The drugmaker said it plans to settle claims stemming from the opioid crisis and lower its debt during the bankruptcy process.
Full Story: Reuters (10/12) 
Johnson & Johnson said it has temporarily halted clinical trials of its COVID-19 vaccine candidate to allow investigation of an unexplained illness in one participant. The company said the patient's condition is being evaluated by its clinical and safety physicians and an independent data and safety monitoring board.
Full Story: Reuters (10/12) 
The US government has signed a supply deal with AstraZeneca worth $486 million for 100,000 doses of the company's investigational COVID-19 antibody treatment should it gain FDA approval, and the agreement also funds two late-stage trials. HHS will provide funding through Operation Warp Speed, with distribution to begin later this year, and a separate deal includes an option to purchase an additional 1 million doses in 2021.
Full Story: United Press International (10/12) 
Using Technology in the Fight Against COVID-19
Health care providers around the world are facing unprecedented challenges but also opportunities to rethink healthcare. What new health IT models have emerged amidst the pandemic? What will the new normal look like? Listen to this panel discussion with healthcare experts around the world to find out. Watch on-demand.
Medical Devices
The FDA has given emergency use authorization to Access Bio for its CareStart COVID-19 Antigen test, to Genalyte for its Maverick SARS-CoV-2 Multi-Antigen Serology Panel v2 and to Spectrum Solutions for its SDNA-1000 Saliva Collection Device.
Full Story: GenomeWeb Daily News (free registration) (10/12) 
The FDA has given emergency use authorization to Abbott for its AdviseDx, a lab-based COVID-19 antibody blood test.
Full Story: Reuters (10/12) 
The FDA has given 510(k) clearance to Olympus America for its PCF-HQ190 and PCF-H190T colonoscopes.
Full Story: MassDevice (Boston) (10/9) 
Food & Dietary Supplements
The FDA has proposed rules to standardize tracing records for foods with a "high risk" for contamination including ready-to-eat salads, shelled eggs, tomatoes, cucumbers and crustaceans. Of particular interest are records of critical tracking events.
Full Story: Supermarket Perimeter (tiered subscription model) (10/7) 
Global Focus
The European Medicines Agency on Oct. 19 will launch an online platform, IRIS, for drug developers to use when seeking scientific advice, protocol assistance and qualification procedures. Users must have an EMA account and register before submitting requests, documentation and other information through IRIS.
Full Story: Regulatory Focus (10/7) 
European regulators have given CE mark approval to Oxford Nanopore for its LamPORE COVID-19 test that has 99.6% specificity and 99.1% sensitivity.
Full Story: FDAnews (10/12) 
Food and Drug Law Institute (FDLI) Highlights
Early Registration Savings End Today: Tobacco and Nicotine Products Regulation and Policy Conference | October 21-23 | Virtual Event
Don't miss the chance to save on registration for FDLI's all-virtual Tobacco and Nicotine Products Regulation and Policy Conference. The three-day conference will cover updates on FDA's comprehensive plan, developments in regulation and enforcement, and important and timely issues. Registrants will receive access to the recorded live sessions of the conference through November 20. Register Now
Next Tuesday: Introduction to Tobacco and Nicotine Products Law and Regulation | October 20 | Virtual Event
Interested in understanding advanced-level topics discussed at the Tobacco and Nicotine Products Regulation and Policy Conference? Explore the essentials of tobacco and nicotine product law and regulation during this virtual introductory course. Learn about FDA's Deeming Rule, the Public Health Standard, Premarket Tobacco Applications (PMTAs), Modified Risk Tobacco Product Applications (MRTPs), compliance, enforcement, advertising and marketing, recent and pending litigation, and more. Register Now
About | Programs | Resources | Engage | Career
  Mid-Level Associate Attorney
View More Listings | Post a Job
Sharing FDLI SmartBrief with your network keeps the quality of content high and these newsletters free.
Help Spread the Word
Or copy and share your personalized link:
A self that goes on changing is a self that goes on living.
Virginia Woolf,
SmartBrief publishes more than 200 free industry newsletters - Browse our portfolio
Sign Up  |    Update Profile  |    Advertise with SmartBrief
Unsubscribe  |    Privacy policy
SmartBrief, Inc.®, 555 11th ST NW, Suite 600, Washington, DC 20004