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HIPAA and Access. Legal Summary and Recent Investigations

The HHS Office of Civil Rights has guidance on how and when covered entities should respond to a right of access request for the personal health information of a patient.

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.

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.

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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3 Ways Marketing Claims Can Destroy Healthcare Companies: FTC, Plaintiff Trolls, & State Regulatory Agencies

Here’s why you need legal review of any information your healthcare company puts out on the Web: advertising claims can not only hurt, they can destroy your healthcare company.

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Why Medical Device Companies Need to Fear FDA Warning Letters

The FDA examines whether medical devices comply with the regulations of the Food, Drug, and Cosmetic Act. Two of the most common violations medical device companies are charged are adulteration [...]

September 2020 FDA Warning Letters

FDA and FTC warning letters continue to find violations of the FD&C Act when companies boast their products can cure or treat diseases such as COVID-19.