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The FDA will not focus on enforcement actions during 2021 for smaller food manufacturers.

FDA Provides Additional Flexibility Regarding Nutrition and Supplement Facts Labels

The U.S. Food and Drug Administration is announcing additional flexibility for manufacturers who need to comply with updated Nutrition and Supplement Facts label requirements by January 1, 2021.

FDA Guidance: Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products

A new 4-page guidance from FDA comes on the heels of an increase in repackaging drugs for administration as a single dose.

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FDA Approves At-Home Breast Cancer Treatment for Administration By Health Care Professionals

Currently, most patients with HER2-positive breast cancer receive the treatment at infusion centers. With a new administration route, Phesgo offers an out-patient option for patients who are vulnerable to the coronavirus.

FDA Commissioner Dr. Stephen Hahn

New FDA Insight Podcast on Emerging Topics

First guest: FDA commissioner Dr. Stephen Hahn on fighting COVID-19 at FDA.

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FDA Authorizes First COVID-19 Test for Patient At-Home Sample Collection

Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.

FDA Issues Temporary COVID-19 Policy for Receiving Facilities and FSVP Importers

New temporary policy for meeting FSMA Supplier Verification Onsite Audit Requirements

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FDA Releases Small Entity Compliance Guide on the Nutrition and Supplement Facts Labels

Compliance required by January 1, 2020, for manufacturers with $10 million or more in annual food sales; manufacturers with less than $10 million in annual food sales have an another year to comply.

Descovy / Image: Gilead

FDA Approves HIV Drug, But Only for Men

Gilead Sciences only tested Descovy on men and transgender women, and the approval explicitly excludes cisgender women.

Opioids / Image: iStock

FDA and DEA Target More Illegal Opioid Websites

In the continued fight against the opioid crisis, the FDA and DEA issued joint warning letters to websites illegally marketing and selling opioids.