Thursday, July 2, 2020

7 days ago - Compounded drugs can serve an important role in meeting patients' medical needs that cannot be met by an FDA-appro... Tuesday, August 6, 2019 (0 Comments ..

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1 day ago - This type of fraud caused tricare to change its compounded drug reimbursement policy in may 2020. However, it is estimated that from 2020 to may 2020 over $2 ...
7 days ago - Vizient offers insights to FDA and USPTO on actions to increase access to compounded drugs and improve opportunities for new generics and biosimilars.

Market for Compounded Drugs Needs Greater Transparency

4 days ago - Many hospitals and medical practices rely on compounding pharmacies to produce drugs that meet patients' clinical needs when available medications ...

Report calls for limits on compounded bioidentical hormone therapy Posted 02 July 2020 | By Denise Fulton

Manufacturing FDA blasts California compounding pharmacy for facility 'contaminated with filth' by Kyle Blankenship | Jul 2, 2020 8:40am
The U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 pandemic:

  • The U.S. Food and Drug Administration (FDA) issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures, and highlights of the agency's response efforts.
  • As part of continued action to protect the American public, the FDA is warning consumers and health care professionals about hand sanitizer products that contain methanol (a.k.a. wood alcohol), a substance often used to create fuel and antifreeze. Methanol is not an acceptable active ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested. The agency has seen an increase in hand sanitizer products that are labeled as containing ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. State officials have also reported recent adverse events from adults and children ingesting hand sanitizer products contaminated with methanol, including blindness, hospitalizations and death.
  • Testing updates:
  • To date, the FDA has currently authorized 162 tests under EUAs; these include 136 molecular tests, 25 antibody tests, and 1 antigen test.

Coronavirus (COVID-19) Update: FDA Authorizes Additional COVID-19 Combination Diagnostic Test Ahead of Flu Season

Today, the U.S. Food and Drug Administration further assisted health care providers around the country prepare for the upcoming flu season during the COVID-19 pandemic by issuing an emergency use authorization (EUA) for the third diagnostic test for detection and differentiation of the viruses that cause flu and COVID-19 in individuals suspected of COVID-19 by their healthcare provider to the U.S. Centers for Disease Control and Prevention (CDC). The FDA has previously issued EUAs to BioFire Diagnostics LLC and QIAGEN GmbH for their tests, which include many other respiratory organisms in addition to the viruses that cause flu and COVID-19.

“With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which might be especially worrying for some Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” said FDA Commissioner Stephen M. Hahn, M.D. “With just one swab or sample, combination tests can be used to get answers to Americans faster. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment.”

These combination tests work by testing a single sample from a patient for multiple respiratory diseases, such as COVID-19 and the seasonal flu which can show similar symptoms. There are several important advantages to this combination testing. Taking just one sample from a patient may help alleviate the need for multiple samplings, which means less discomfort for the patient with faster and...

Tuesday, June 30, 2020