Tuesday, July 21, 2020

Physicians need to mitigate risk with compounded drugs

www.healio.com › news › ophthalmology › physicians-ne...

3 hours ago - Understand what type of facility is making compounded medications. Under the U.S. Drug Quality and Security Act, there are two types of compounding ...

07/20/2020	07/20/2020	Ohm City Vapes Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/20/2020	07/20/2020	Hina Singh Enterprises, Inc. d/b/a Just Eliquids Distro Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/20/2020	07/20/2020	HQD Tech USA, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/20/2020	07/20/2020	Breazy Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/20/2020	07/20/2020	Myle Vape, Inc.	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/20/2020	07/20/2020	Majestic Vapors, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/20/2020	07/20/2020	Vape Deal, LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/17/2020	07/09/2020	Hydroxychloroquine-online.com	Center for Drug Evaluation and Research \| CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)
07/17/2020	07/09/2020	Pharmaboosters.com	Center for Drug Evaluation and Research \| CDER	Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

07/21/2020	04/22/2020	Quan 5 Inc. d/b/a District F5VE	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/21/2020	05/19/2020	Tiao Peng Trading, Inc.	Division of West Coast Imports	Foreign Supplier Verification Program (FSVP)
07/21/2020	05/22/2020	Titan Premium Services, LLC d/b/a TitanVapez	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/21/2020	06/11/2020	Centurion Medical Products Corporation	Division of Medical Device and Radiological Health Operations East	CGMP/QSR/Medical Devices/PMA/Adulterated/Misbranded
07/21/2020	07/02/2020	Express Trading International Inc.	Division of Southeast Imports	Foreign Supplier Verification Program (FSVP)
07/21/2020	07/08/2020	Stason Pharmaceuticals, Inc.	Division of Pharmaceutical Quality Operations IV	CGMP/Finished Pharmaceuticals/Adulterated
07/21/2020	07/14/2020	Signa SA de CV	Center for Drug Evaluation and Research \| CDER	CGMP/Active Pharmaceutical Ingredient (API)/Adulterated
07/20/2020	07/20/2020	E Cigarette Empire LLC	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/20/2020	07/20/2020	Cool Clouds Distribution, Inc. d/b/a Puff Bar	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded
07/20/2020	07/20/2020	Eleaf USA	Center for Tobacco Products	Family Smoking Prevention and Tobacco Control Act/Adulterated/Misbranded

Doctors And Dentists Still Flooding U.S. With Opioid Prescriptions

Doctors And Dentists Still Flooding U.S. With Opioid Prescriptions
Forty Americans die every day from overdoses linked to prescription opioids, but researchers say many doctors and dentists still have a "prescribe and forget" attitude toward the medications.

Read in NPR: https://apple.news/AQKZh9pNoTzKraATzyyBeQg

Genetic Testing: The New Wild West for Health Care Fraud Alexander M. Owens

https://www.americanbar.org/groups/criminal_justice/publications/criminal-justice-magazine/2020/spring/genetic-testing-new-wild-west-health-care-fraud/?utm_medium=email&utm_source=salesforce_243194&sc_sid=01014961&utm_campaign=MK20CNTT&promo=MKCONTENT1&utm_content=&additional4=&additional5=&sfmc_j=243194&sfmc_s=46719069&sfmc_l=2198&sfmc_jb=74&sfmc_mid=100027443&sfmc_u=7727836

Monday, July 20, 2020

Florida hospitals beg feds for more drugs as virus cases rise

Florida hospitals said they are in desperate need of a life-saving medication to help treat the coronavirus patients rapidly filling their beds as cases across the state continue to rise at alarming rates.

FDA Protects Patients and Consumers from Fraud During COVID-19

Throughout the pandemic, the U.S. Food and Drug Administration has found many nefarious actors seeking to exploit consumers during the pandemic by selling unproven medical products often with fraudulent claims. The emergence of fraudulent medical products is a common phenomenon during crisis situations. For example, in 2013, the FDA issued 10 warning letters to firms selling unproven medical products with false or misleading claims to protect against influenza. In 2014, 7 warning letters were issued for unproven and fraudulent Ebola products.

The FDA is well-equipped to rapidly identify and thwart medical product scams to protect consumers.

Read More

Saturday, July 18, 2020

Coronavirus (COVID-19) Update: FDA Issues First Emergency Authorization for Sample Pooling in Diagnostic Testing

Today, the U.S. Food and Drug Administration reissued an emergency use authorization (EUA) to Quest Diagnostics to authorize its Quest SARS-CoV-2 rRT-PCR test for use with pooled samples containing up to four individual swab specimens collected under observation. The Quest test is the first COVID-19 diagnostic test to be authorized for use with pooled samples.

Sample pooling is an important public health tool because it allows for more people to be tested quickly using fewer testing resources. Sample pooling does this by allowing multiple people – in this case four individuals – to be tested at once. The samples collected from these four individuals are then tested in a pool or “batch” using one test, rather than running each individual sample on its own test. If the pool is positive, it means that one or more of the individuals tested in that pool may be infected, so each of the samples in that pool are tested again individually. Because the samples are pooled, it is expected that fewer tests are run overall, meaning fewer testing supplies are used and more tests can be run at the same time allowing patients to...