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FDA: Compounding Research

3 days ago - FDA is engaged with the following institutions to conduct research to help inform the public and the agency's policies regarding compounded drugs.
2 days ago - The United States has its first novel coronavirus-related drug shortage, according to the US Food and Drug Administration. The maker of an unnamed drug that has recently been added to the FDA Drug Shortages list told the agency that the shortage is due to the novel coronavirus.
22 hours ago - The agency cited confidential commercial information in not revealing the name of the drug, but critics say releasing details is vital in a public health crisis.

5 days ago - About 150 prescription drugs — including antibiotics, generics and some branded drugs without alternatives — are at risk of shortage if the coronavirus outbreak .

Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics

Today, as part of the U.S. Food and Drug Administration’s ongoing and aggressive commitment to address the coronavirus outbreak, the agency issued a new policy for certain laboratories seeking to develop diagnostic tests for coronavirus in order to achieve more rapid testing capacity in the U.S.

“We believe this policy strikes the right balance during this public health emergency,” said FDA Commissioner Stephen M. Hahn, M.D. “We will continue to help to ensure sound science prior to clinical testing and follow-up with the critical independent review from the FDA, while quickly expanding testing capabilities in the U.S. We are not changing our standards for issuing Emergency Use Authorizations. This action today reflects our public health commitment to addressing critical public health needs and rapidly responding and adapting to this dynamic and evolving situation.”

There is currently an outbreak of respiratory disease caused by a novel coronavirus that was first detected in Wuhan City, Hubei Province, China and which has now been detected in 50 locations internationally, including cases in the United States. The virus has been named “SARS-CoV2” and the disease it causes has been named “Coronavirus Disease 2019” (COVID-19). SARS-CoV-2 has demonstrated the capability to rapidly spread, leading to significant impact on health care systems and causing societal disruption. The potential public health threat posed by COVID-19 is high, both globally and to the U.S. To effectively respond to the COVID-19 outbreak, rapid detection of cases and contacts, appropriate clinical management and infection control, and implementation of community mitigation efforts are critical. This can best be achieved with ...

Coronavirus Update: FDA steps to ensure quality of foreign products

This statement is attributed to: FDA Commissioner Stephen M. Hahn, M.D., and Judy McMeekin, Pharm.D., Acting Associate Commissioner for Regulatory Affairs 
Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak:  COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity as we oversee the safety and quality of FDA-regulated products for American patients and consumers.

Today, we are providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by this outbreak. While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue ....
8 hours ago - In the U.S., there are 12 cases of people with the novel coronavirus who had traveled to China. Two of their spouses were infected upon their return. In additio
8 hours ago - Public health officials, experts and members of Congress this week sounded new alarms about the spread of a coronavirus that broke out in China late last year, 
5 hours ago - See the number of people under investigation (PUIs) in the United States and states with confirmed cases of Coronavirus Disease 2019 (COVID-19).
18 hours ago - South Korea has emerged as a hot spot for the virus, with infections surging to more than 1,200. Italy reported an 11th fatality, while Iran has seen 15. A Brazilian ...
18 hours ago - His wife, who works in a kindergarten, was also confirmed to have contracted the virus. Germany, which has now reported 19 confirmed cases, has been braced ...
20 hours ago - As of Wednesday midday, there are 374 confirmed cases of the virus and 12 deaths. Towns in the northern region of Lombardy and Veneto remain under ...

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9 hours ago - The number of new COVID-19, or coronavirus, infections outside China has outpaced those inside the country for the first time, according to the World Health Organization (WHO). “The sudden increases of cases in Italy, the Islamic Republic of Iran and the Republic of Korea are ...
4 hours ago - Hope for treating the novel coronavirus could be on the horizon, as the first US study of a drug to treat the illness is underway. So far, there is no cure or vaccine for the virus, which has infected more than 80,000 people and killed more than 2,700 worldwide in the past few ...

February 26, 2020 Pioneer Drug Maker Throws First Punch At Pharmacy Outsourcing Facilities (503b)

"Azurity Pharmaceuticals, Inc. — a pioneer drug company that markets its FDA-approved oral vancomycin hydrochloride solution, FIRVANQ® — has sued Edge Pharma, LLC, an outsourcing facility operating pursuant to section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA), for compounding an oral vancomycin hydrochloride solution that is identical or nearly identical to FIRVANQ."  More Here