| 01/05/2021 | 12/18/2020 | Reddy Naturals | Division of Human and Animal Food Operations East III | New Drug/Misbranded | ||
| 01/05/2021 | 01/04/2021 | Coco's Holistic Specialties & Apothecary | Center for Drug Evaluation and Research | CDER | Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19) |
The civil False Claims Act is an important tool used to protect the integrity of taxpayer-funded health care programs and allows the government to address losses it sustains by providing for civil monetary penalties.
The following is attributed to Patrizia Cavazzoni, M.D., acting director of the Center for Drug Evaluation and Research
Advances in scientific knowledge and drug development technology have provided an opportunity for new approaches to drug development, including the development of drugs for the treatment of rare diseases. These advances have contributed to an increase in development and approval of drugs for the treatment of rare diseases in recent years. In fact, in the past eight years, the U.S. Food and Drug Administration has approved more than twice as many drugs for rare diseases, often referred to as orphan drugs, as in the previous eight years.
For genetic diseases, recent approaches to testing and molecular diagnosis have allowed us to pinpoint, in some cases, the exact cause of a patient’s disease. For a patient with a very rare genetic disease...
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“Although this pet food recall is still unfolding, we are sharing the facts we have so far because the levels of aflatoxin found in the recalled pet food are potentially fatal. We are working quickly on this developing situation and will continue to update the public as new information becomes available. This is in service of FDA’s mission to protect human and animal health.”
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