2021 Forecast Includes Rise In FDA Enforcement Actions
The Biden administration may take a heavier hand with manufacturers than we saw in recent years, attorneys say.
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Two QA/RA experts highlight hot-button topics that quality assurance and regulatory affairs professionals should keep an eye on in the medtech space this year.
A sharp decline in the number of in-person facility inspections has forced the FDA to consider creative techniques for remotely evaluating manufacturer compliance during the COVID-19 pandemic. This and other stories topped our list of most-read Medtech Insight articles in November.
The tug of war between the US HHS and the FDA over laboratory developed tests took a surprising turn on 7 October when the agency declared that it will no longer issue emergency use authorizations for LDTs. That means unapproved COVID-19 tests that come to market without an EUA won’t be covered under the PREP Act, which protects makers of pandemic-fighting products from lawsuits.