Question

Students should be paired or put into small groups and together they should use the provided word document to select one Regulatory or Advisory Agency from the list.
After selecting the agency they will research their website and come up with a PowerPoint presentation to share with the class.
The presentation should have a minimum of 3 slides.
The slides should explain whether their selection is a regulatory or advisory agency, and what types of regulations/recommendations they provide.

our presentation is going to be about us food and drug administration
give me one slide to add to the presentation

Answer 1

Title: U.S. Food & Drug Administration — Regulatory or Advisory?

- Primary role: Federal regulatory agency (part of HHS) — enforces laws to protect public health.
- Also issues non‑binding guidance and recommendations to help industry follow regulations.

Key areas it regulates / recommends:
- Drugs & biologics (prescription, OTC, vaccines): IND, NDA, BLA approvals; clinical trial oversight
- Medical devices: 510(k) clearance, PMA approval, device classification
- Food safety & labeling: safety standards, ingredient approvals, recalls, infant formula oversight
- Tobacco & nicotine products: premarket review and marketing orders
- Cosmetics, animal drugs/feeds, radiation‑emitting products

How it acts:
- Pre‑market review and approvals, Good Manufacturing Practices (cGMP) inspections
- Post‑market surveillance: adverse event reporting, safety communications, recalls, Enforcement (warning letters, seizures)
- Emergency tools: Emergency Use Authorizations (EUAs)
- Provides guidance documents (advisory) to clarify expectations

Source: fda.gov

Speaker note (one line): The FDA is mainly a regulatory body that also issues advisory guidance to help industry comply and to protect public health.