FDA & Life Sciences

Plain answers to FDA and Life Sciences questions, with every citation independently ruled by the Kingsfield judge against the primary-law corpus.

• What is the 75-day premarket notification requirement for a new dietary ingredient?21 CFR 190.6(a) · 21 USC 350b(a)
• What is the FDA's definition of a dietary supplement?21 USC 321(ff)
• What are the current good manufacturing practice (cGMP) requirements for dietary supplements?21 CFR 111.1 · 21 CFR 111.70
• How does the FDA classify medical devices into Class I, II, and III?21 USC 360c · 21 CFR 807.81