Tuesday, November 24, 2020
Doctor Fails to Overturn Conviction for Kickback Payments
State Board Pharmacy Rules - Code of Colorado Regulations
Avalere Statement on Trump Administration Drug Pricing ...
November 19, 2020 - United States Court of Appeals
Sentence upheld for pharmacy exec convicted of distributing ...
Scammer to repay $743,775 - The Arkansas Democrat-Gazette
Department of Justice
Former Pharmacy and Marketing Company Sales Representative Admits Role in Compounded Prescription Drug Scheme
OIG to conduct risk assessment of CMS's oversight of pharmacies compounding drugs--expected completion date 2022
Medicare Part D Compounded Drugs
In 2016, OIG called attention to significant growth in spending for compounded drugs. Specifically, OIG found that Medicare Part D spending for compounded topical drugs grew by 625 percent during 2006—2015. OIG has been involved in an increasing number of fraud investigations related to compounded drugs. We will conduct a risk assessment of CMS's oversight of pharmacies compounding drugs for beneficiaries to determine whether systemic vulnerabilities affecting the integrity of Medicare Part D; specifically, we will assess the risk that pharmacies did not meet Federal and State requirements.
Medicare Part D Compounded Drugs
|11/24/2020||10/16/2020||Aurolife Pharma, LLC||Division of Pharmaceutical Quality Operations I||CGMP/Finished Pharmaceuticals/Adulterated|
|11/24/2020||11/16/2020||Harmonic Nature S. de R.L. MI.||Center for Drug Evaluation and Research | CDER||Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated|
|11/24/2020||11/19/2020||Liq-E S.A. De C.V.||Center for Drug Evaluation and Research | CDER||Finished Pharmaceuticals/Unapproved New Drug/Misbranded/Adulterated|
|11/20/2020||11/18/2020||Vibrant Health Care, Inc.||Center for Biologics Evaluation and Research (CBER)||Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)|
|11/19/2020||11/18/2020||Pro Breath MD, LLC dba Dentist Select and OraCare||Center for Drug Evaluation and Research | CDER||Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)|
Wednesday, November 18, 2020
Coronavirus (COVID-19) Update: FDA Authorizes First COVID-19 Test for Self-Testing at Home
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first COVID-19 diagnostic test for self-testing at home and that provides rapid results. The Lucira COVID-19 All-In-One Test Kit is a molecular (real-time loop mediated amplification reaction) single use test that is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19.
“The FDA continues to demonstrate its unprecedented speed in response to the pandemic. While COVID-19 diagnostic tests have been authorized for at-home collection, this is the first that can be fully self-administered and provide results at home. This new testing option is an important diagnostic advancement to address the pandemic and reduce the public burden of disease transmission,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action underscores the FDA’s ongoing commitment to expand access to COVID-19 testing.”
The Lucira COVID-19 All-In-One Test Kit test has been authorized for home use with self-collected nasal swab samples in individuals age 14 and older who are suspected of COVID-19 by their health care provider. It is also authorized for use in point-of-care (POC) settings (e.g., doctor’s offices, hospitals, urgent care centers and emergency rooms) for all ages but samples must be collected by...
While the offering could boost convenience and transparency, industry observers didn't expect it to disrupt the pharmaceutical industry.
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Tuesday, November 17, 2020
Key facts in how compounding pain scheme evolved: Wade Walters testifies against doctor in MS compounded pain cream fraud case