FDA Law Blog
SEPTEMBER 16, 2024
FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies. This would include continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment and novel analytical methods.
FDA Law Blog
NOVEMBER 22, 2022
Gaulkin — At the risk of ruining our readers’ appetite for America’s most food-focused holiday, foodborne illnesses have been a feature of Thanksgiving for some time now. When foodborne illness outbreaks arise, efficient traceability is critical to prevent illnesses, death, and unnecessary product loss.
FDA Law Blog
JANUARY 9, 2024
This request must provide details about, among other things: The foreign seller that will purchase the prescription drug directly from its manufacturer, along with invoices, batch, and lot/control numbers to verify the sale and the units sold. See 21 C.F.R. 251.5; § 251.6(c).
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