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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.
Sep 18th, 2020
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.
Aug 3rd, 2020
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.
Jul 10th, 2020
New FDA Insight Podcast on Emerging Topics
First guest: FDA commissioner Dr. Stephen Hahn on fighting COVID-19 at FDA.
Jun 24th, 2020
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.
Apr 28th, 2020
FDA Issues Temporary COVID-19 Policy for Receiving Facilities and FSVP Importers
New temporary policy for meeting FSMA Supplier Verification Onsite Audit Requirements
Mar 18th, 2020
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.
Feb 3rd, 2020
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.
Oct 10th, 2019
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.
Oct 3rd, 2019