Relaxing Vaccine Dosage and Food Label Requirements

The Food and Drug Administration issues a press release that said, even though the pandemic is severe, patients should receive the mRNA vaccines in two properly timed doses.

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How Have States Relaxed the Telemedicine Requirement of a Good Faith or Appropriate Prior Exam?

Many states are easing the restrictions on using telehealth during COVID including easing licensing requirements and in-person visit requirements.

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Additional State Telehealth Waivers During the COVID-19 Pandemic. Part Three.

Many states, such as Illinois, Iowa, Massachusetts, Minnesota, New Jersey, and North Carolina, are easing the restrictions on using telehealth serviced during the COVID pandemic.

Johnson and Johnson’s COVID-19 Vaccine Should Be Reviewed by FDA Soon

Johnson & Johnson’s adenovirus-based vaccine for preventing the transmission of COVID-19 is expected to be reviewed by the Food and Drug Administration in February 2021.

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Additional State Telehealth Waivers During the COVID-19 Pandemic. Part Two.

Many states, such as Florida, Kansas, Kentucky, Michigan, and New York are easing the restrictions on using telehealth serviced during the COVID pandemic.

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Stark Law Blanket Waivers during COVID

The Centers for Medicare & Medicaid (CMS) identified 18 waivers to Stark Law’s prohibition against self-referrals. The waivers are based on the form of remuneration and the type of financial [...]

FDA Warning Letters – COVID-19 Testing Kits

FDA is sending warning letters to companies that claim the company can diagnose COVID-19. FDA has granted an Emergency Use Authorization) for at least one at-home testing kit.

FDA Reviewing Moderna’s COVID-19 Vaccine

An Advisory Panel for the Food and Drug Administration is reviewing a request by Moderna for its COVID-19 vaccine. Moderna’s vaccine is expected to be distributed in the coming months.

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FDA Approves Authorized Use of a COVID-19 Test Product

FDA granted emergency use authorization to Lucira Health Inc. for a COVID-19 self-testing kit. The EUA has numerous conditions that the manufacturer must meet.

FDA Issues Emergency Use Authorization for Pfizer COVID-19 Vaccine

FDA granted an Emergency Use Authorization to a COVID-19 vaccine developed by Pfizer, Inc. Doses of the vaccine have already been administered to health workers

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