FDA Grants Accelerated Approval for a New Alzheimer’s Disease Treatment

The FDA recently approved the drug, of Leqembi, a treatment of Alzheimer’s disease, through the accelerated approval process.

FDA Laws and Regulations About The Metaverse

Many metaverse augmented reality, virtual reality, artificial intelligence, and other med-tech applications will need to meet FDA medical device requirements.

Legal Compliance Issues for Integrative Cardiology

Integrative cardiology practitioners, doctors and non-physicians, need to review their working relationship for violations of state licensing laws, HIPAA, self-referral laws, and other legal [...]

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.

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