https://www.npr.org/2020/02/29/810722517/seattle-area-patient-with-coronavirus-dies
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Saturday, February 29, 2020
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 .
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Wednesday, February 26, 2020
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2/25/2020 | 02/14/2020 | Essnd Global | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
02/25/2020 | 02/13/2020 | Yibin Lihao Bio-technical Co., Ltd. | Center for Drug Evaluation and Research | CDER | CGMP/Active Pharmaceutical Ingredient (API)/Adulterated |
02/25/2020 | 02/13/2020 | JHS Svendgaard Hygiene Products Ltd | Center for Drug Evaluation and Research | CDER | CGMP/Finished Pharmaceuticals/Adulterated |
02/25/2020 | 02/12/2020 | Market America Inc | Office of Human and Animal Foods - East 3 | CGMP/Dietary Supplement/Adulterated/Misbranded |
02/25/2020 | 02/11/2020 | KVK-Tech, Inc | Division of Pharmaceutical Quality Operations I | CGMP/Finished Pharmaceuticals/Adulterated |
02/25/2020 | 01/09/2020 | Hindy Import Inc. | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
02/25/2020 | 09/25/2019 | Banjaras Inc | Division of Southwest Imports | Foreign Supplier Verification Program (FSVP) |
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).
Airport officials say 200 travelers coming through Atlanta's airport have shown potential symptoms of the coronavirus.
4 hours ago - Airport officials say 200 travelers coming through Atlanta's airport have shown potential symptoms of the coronavirus.
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 ...
Trump urges calm even as US reports worrisome new virus case President Donald Trump says the U.S. is “very, very ready” for whatever the new coronavirus threat brings, even as health authorities warn Americans that more infections are coming By LAURAN NEERGAARD and RICARDO ALONSO-ZALDIVAR Associated Press
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
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