News & Analysis as of

Warning Letters Pharmaceutical Industry Coronavirus/COVID-19

Health Care Compliance Association (HCCA)

In This Month’s E-News: August 2024

The Food and Drug Administration (FDA) has given Massachusetts Institute of Technology (MIT) 15 days from receipt of its June 21 warning letter to elaborate on corrective actions to address violations of federal requirements...more

Paul Hastings LLP

Post-COVID Checkup: Current FDA Due Diligence Considerations

Paul Hastings LLP on

The COVID-19 pandemic highlighted both the incredible promise and challenges for life science companies developing and manufacturing drugs, biological products, and devices that enhance our lives....more

Womble Bond Dickinson

Can hashtags get you in trouble?

Womble Bond Dickinson on

They can if you operate in a regulated industry, such as pharma, med devices, cannabis, dietary supplements, etc. FDA has specific labeling requirements for products and they look at hashtags related to products the same...more

Hogan Lovells

FDA cracks down on pharmaceutical firm for misbranding drug as COVID-19 treatment

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more

Morgan Lewis

Recent FDA Medical Device Developments in Response to COVID-19

Morgan Lewis on

The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more

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