Azar: Governors to decide who gets COVID-19 shots first | Biden: Experts to decide on COVID-19 vaccine prioritization | FDA guidances target complex generics, DDT qualification
November 30, 2020
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Drugs & Biologics
Canada to limit Rx drug exports to US
(Pixabay)
The Canadian government announced a new measure to block bulk exports of certain prescription drugs if doing so would result in a drug shortage. The policy took effect Friday ahead of a Trump administration rule that would permit US wholesalers or pharmacists to import some prescription drugs in bulk from Canada.
Full Story: Reuters (11/29) 
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The CDC's Advisory Committee for Immunization Practices is set to hold an emergency meeting Tuesday to vote on who should receive the COVID-19 vaccine first, once one is authorized by the FDA, and the CDC has already recommended that the first group include front-line health workers, support personnel, and residents of long-term-care facilities and nursing homes. HHS Secretary Alex Azar, however, said the government won't wait for ACIP's recommendations before shipping the initial doses, which is expected to happen within 24 hours of FDA authorization, and state governors will have the final say on who will get the first shots.
Full Story: CNN (11/30),  Politico (11/24) 
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President-elect Joe Biden will let health experts, particularly the CDC, decide who will be prioritized to receive the first available COVID-19 vaccines authorized by the FDA, according to Celine Gounder, a member of his coronavirus advisory board. The CDC's Advisory Committee for Immunization Practices is tasked with recommending which high-risk groups will be given the vaccine first.
Full Story: CNN (11/28) 
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The FDA has released a final guidance detailing how complex generic developers can request and schedule formal meetings with the FDA as part of the abbreviated new drug application process. A second finalized guidance explains the details of the FDA qualification process for drug development tools.
Full Story: Regulatory Focus (11/25) 
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Medical Devices
The FDA has given emergency use authorization to Kantaro Biosciences for its COVID-SeroKlir antibody test that has 99.6% specificity and 98.8% sensitivity.
Full Story: MassDevice (Boston) (11/25) 
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The FDA has given emergency use authorization to RapidRona for its Self-Collection Kit and to Gravity Diagnostics for its SARS-CoV-2 RT-PCR assay.
Full Story: GenomeWeb Daily News (free registration) (11/25) 
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The FDA has given 510(k) clearance to CorticoMetrics for its THINQ, an artificial intelligence-based software that performs visualizations and volumetric measurements of the brain.
Full Story: FDAnews (11/30) 
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Food & Dietary Supplements
Dole recalls 2 romaine products on E. coli fears
(Pixabay)
Dole Fresh Vegetables has issued a 15-state recall on two products on concerns about potential E. coli contamination, according to the FDA. The voluntary recall covers the three-pack of Dole Romaine Heart and Wild Harvest Romaine Hearts, with harvest dates between Oct. 23 and Oct. 26.
Full Story: USA Today (11/24) 
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Global Focus
Moderna has finalized its deal with the European Commission to initially supply 80 million doses of mRNA-1273, its experimental COVID-19 vaccine candidate. The deal includes an option to purchase an additional 160 million doses of the vaccine.
Full Story: PharmaTimes online (UK) (11/26) 
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Hot Topics
Food and Drug Law Institute (FDLI) Highlights
Legal and Practical Issues in the Evolving World of Cannabis Regulation | December 8-9 | Virtual Event
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Savings end this Friday for FDLI's Legal and Practical Issue in the Evolving World of Cannabis Regulation Conference. The conference examines the present reality of this unique industry from legal and practical perspectives and guides you on navigating this constantly changing environment. Industry experts untangle issues related to CBD, cannabis, and other cannabinoids, various regulated product areas (e.g., topicals, supplements, edibles, drugs), and state vs. federal regulation. Register Now
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Tuesday's Virtual Happy Hour: Update Magazine Authors Discuss FDA Advisory Panel Meetings | December 1, 5:00 PM EST
We invite FDLI members to our virtual "Author Happy Hour" to discuss the article, "Bad News for Device Sponsors: Panel Meetings were Already Going the Way of the Homework Assignment, and COVID Might 'Put the Nail in the Coffin." Join authors to discuss FDA's advisory panel meetings to review new medical devices, the shift to written responses by outside experts and virtual panels, and the subsequent impacts to manufacturers. Register Now
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