Psychedelic Therapy Training Program Launched
October 19, 2020 | Rivkin Rounds Staff | Behavioral Health | FDA | Hospitals | Pharmaceuticals
Mind Medicine, Inc. (MindMed) and NYU Langone Medical Center (NYU) recently announced a joint project to launch a clinical training program focused on psychedelic-assisted therapies and psychedelic-inspired medicines. MindMed, a psychedelic drug startup, is studying the use of hallucinogenic drugs in the treatment of mental health conditions. This venture is the first step in establishing a …
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FDA Announces Digital Health Center of Excellence
October 7, 2020 | Electronic Health Records | FDA | Home Health | Legislation and Public Policy | Medical Devices and Wearables | Telehealth
On September 22, the U.S. Food and Drug Administration (FDA) announced the launch of its Digital Health Center of Excellence within the Center for Devices and Radiological Health. The FDA called this an important step toward its goal of advancing digital health technology, including mobile health (mHealth), health information technology, wearable devices, telehealth, and personalized …
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Ullman to be Panelist at COVID-19 Webinar for Practitioners on 10/7
October 6, 2020 | Rivkin Rounds Staff | COVID-19 | FDA | Fraud and Abuse | Legislation and Public Policy
In the words of the American Association of Naturopathic Physicians: “Since March, the Federal Trade Commission (FTC) and Food and Drug Administration (FDA) have been aggressive in policing online language about COVID—and with good reason! Fraudulent products and false claims abound.” In one such instance, discussed here, the U.S. Department of Justice charged a physician with …
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DOJ Charges California Physician with COVID-19 Fraud
April 21, 2020 | Marc S. Ullman | COVID-19 | FDA | Fraud and Abuse | Litigation | Pharmaceuticals
On April 16, the United States Attorney’s Office for the Southern District of California charged Dr. Jennings Ryan Staley, a licensed physician and the operator of Skinny Beach Med Spa in San Diego, with mail fraud in connection with his offer to sell “COVID-19 treatment packs” to patients and the general public. Emails sent by Dr. Staley …
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FDA Takes Steps to Speed COVID-19 Imports
April 6, 2020 | Marc S. Ullman | COVID-19 | FDA
On April 3, the U.S. Food and Drug Administration (FDA) posted a notice that it has created a special email address in order to assist importers who are experiencing delays bringing COVID-19-related supplies into the U.S. According to the notice, the primary reason for the delays is confusion relating to the difference between personal and commercial …
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CARES Act: Diagnostic Testing and Laboratory-Related Provisions
March 26, 2020 | Geoffrey R. Kaiser | COVID-19 | FDA | Legislation and Public Policy | Medicare and Medicaid | Private Insurers
Several of the provisions in the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) passed by the Senate on March 25 relate to laboratory diagnostic testing for the COVID-19 virus. Within Division A of the CARES Act, titled “Keeping Workers Paid and Employed, Health Care System Enhancements, and Economic Stabilization,” there are four sections …
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FDA Reassures on Safety of U.S. Food Supply
March 26, 2020 | Marc S. Ullman | COVID-19 | FDA | Legislation and Public Policy
Amidst concerns over the rapid spread of COVID-19, on March 24, U.S. Food and Drug Administration (FDA) Deputy Commissioner for Food Policy and Response Frank Yiannas issued a statement advising Americans that “there is no evidence of human or animal food or food packaging being associated with transmission of the coronavirus that causes COVID-19.” Yiannas noted …
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FDA Announces Modified Inspection Protocols
March 20, 2020 | Marc S. Ullman | COVID-19 | FDA | Legislation and Public Policy
In order to ensure the safety and health of its workforce and regulated industry, on March 18, the U.S. Food and Drug Administration (FDA) announced that it was suspending routine domestic facility inspections in order to limit potential exposure to COVID-19 for investigators and workers at facilities. FDA had previously announced that it was suspending …
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FTC and FDA Take Joint Action to Stop COVID-19 Fraud
March 16, 2020 | Marc S. Ullman | COVID-19 | FDA | Fraud and Abuse | Legislation and Public Policy | Litigation
On March 6, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) issued joint Warning Letters to seven companies calling for them to cease marketing products appearing to violate federal law by making deceptive or scientifically unsupported claims about their ability to treat Coronavirus (COVID-19). The companies targeted, (1) Vital Silver, (2) Quinessence …
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FDA Warns 15 More Companies on CBD
November 26, 2019 | Eric D. Fader | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
On November 25, the U.S. Food and Drug Administration announced the issuance of warning letters to 15 companies that it says are violating the Federal Food, Drug, and Cosmetic Act by selling cannabidiol (CBD) products. The FDA’s views on the recent CBD marketing frenzy have been no secret, as previously discussed here. The FDA also …
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