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FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

The Pharma Data

Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. Hahn , M.D.

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Transforming Biomanufacturing: Potential of Cell Free Systems

Roots Analysis

Biomanufacturing utilizing cell free systems is an emerging area of research that enables the synthesis of different biomolecules, such as cytotoxic proteins, fusion proteins, post translationally modified proteins, antibodies, enzymes, vaccines and other complex proteins, without the use of living cells.

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Top 10 Foods Banned in the US

XTalks

The FDA, established in 1906, is responsible for the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, medical devices and veterinary products. Since 1980, puffer fish has been on the FDA’s Automatic Detention List.

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FDA Takes Steps to Limit Lead in Juice to Further Reduce Exposure to Toxic Elements in Foods

The Pharma Data

In particular, Action Levels for Lead in Juice: Draft Guidance for Industry , provides draft action levels of 10 parts per billion (ppb) for lead in single-strength apple juice and of 20 ppb for lead in all other single-strength juice types, including juice blends that contain apple juice.

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FDA In Brief: Certain Lots of Sportmix Pet Food Recalled for Potentially Fatal Levels of Aflatoxin

The Pharma Data

that may contain potentially fatal levels of aflatoxin. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. This is an ongoing investigation.

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FDA Approves New Imaging Drug to Help Identify Ovarian Cancer Lesions

The Pharma Data

The use of folate, folic acid, or folate-containing supplements should be avoided within 48 hours before administration of Cytalux. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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FDA Makes Low-Risk Determination for Marketing of Products from Genome-Edited Beef Cattle After Safety Review

The Pharma Data

Today’s decision underscores our commitment to using a risk and science-based, data-driven process that focuses on safety to the animals containing intentional genomic alterations and safety to the people who eat the food produced by these animals,” said Steven M. Solomon, D.V.M., director of the FDA’s Center for Veterinary Medicine.

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