July 30, 2021
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Drugs & Biologics
FDA's CDER warns Amazon over misbranded drugs
(Nathan Stirk/Getty Images)
The FDA's Center for Drug Evaluation and Research sent an untitled letter to online retailer Amazon for misbranding drugs and marketing unapproved drugs in violation of certain sections of the Federal Food, Drug and Cosmetic Act. In a letter sent to Amazon CEO Andy Jassy, the FDA said it identified 26 weight loss and sexual enhancement products being sold on Amazon that contained one or more of the active pharmaceutical drug ingredients tadalafil, sildenafil or vardenafil, that were not declared on the labeling of the products.
Full Story: Regulatory Focus (7/29) 
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Kaiser Foundation Health Plan has filed a lawsuit accusing Merck and the firm manufacturing generics of its popular cholesterol drugs Vytorin and Zetia of delaying generic competition for the two drugs and violating antitrust laws. Kaiser Permanente's health plan claims it paid hundreds of millions more for the two cholesterol drugs as a result of a pay-for-delay scheme.
Full Story: FierceHealthcare (7/29),  The Business Journals (tiered subscription model) (7/28) 
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The FDA has allowed Emergent BioSolutions to resume production of the drug substance used in Johnson & Johnson's COVID-19 vaccine at its previously troubled plant, although the facility has yet to be fully authorized by the FDA and individual lots of vaccines still need to be inspected by the agency prior to shipment and administration, according to an unnamed administration official.
Full Story: CNN (7/29) 
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Eli Lilly's baricitinib was granted expanded emergency use authorization by the FDA as a COVID-19 drug that can be administered separately from Gilead's remdesivir. The expanded authorization was based on results from a trial involving 1,525 hospitalized COVID-19 patients that showed those treated with baricitinib had a lower risk of progressing to ventilator use or death compared with patients given standard of care.
Full Story: Reuters (7/29) 
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Medical Devices
The FDA has given 510(k) clearance to Asensus Surgical for its 5 mm diameter articulating instruments for its Senhance surgical system.
Full Story: FDAnews (7/29) 
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The FDA has given breakthrough status designation to Biofourmis for its BiovitalsHF medical device software that is used to treat heart failure.
Full Story: FDAnews (7/30) 
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The FDA has given 510(k) clearance to NYU Langone Health for its Genome PACT genetic test for solid tumors.
Full Story: GenomeWeb Daily News (free registration) (7/29) 
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European regulators have given CE mark certification to MeMed for its MeMed COVID-19 Severity tool that could help determine the risk of severe outcomes in people.
Full Story: Medical Device Network (UK) (7/28) 
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Food & Dietary Supplements
McCormick & Co. is recalling several seasonings due to potential salmonella contamination discovered during routine FDA testing. The affected products were shipped to over 30 US states, Canada and Bermuda from June 20 to July 21.
Full Story: HealthDay News (7/29) 
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Food and Drug Law Institute (FDLI) Highlights
Important Updates for 2021 Programs
With the country opening up, FDLI remains committed to providing high-quality educational programs in a way that keeps our members and event attendees safe. After discussions with our conference committees, and taking into account the unique aspects of each program and the need to remain flexible, we have revised the fall program to include two hybrid programs (both in-person and virtual) and one in-person program. All in-person plans are subject to change as needed to protect the health and safety of the FDLI community. View Programs
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The Hazy Legal Status of Delta-8 THC and Other Chemically Modified Cannabinoids | August 25, 2:00 - 3:30 PM EDT | Live Webinar
This webinar will delve into the chemistry of delta-8 THC and other psychoactive cannabinoids, how they are derived, possible safety concerns, and their similarities and differences from delta-9 THC. Speakers will discuss the legal status of these relatively new cannabinoids under FDA and DEA rules, the evolving nature of state bans, and the potential influence on policy discussions about other cannabis products. Register Now
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And that's the world's biggest problem: the future is seen as someone else's concern.
David A. Sinclair,
biologist, professor of genetics
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