RAC Chapter 1 - FDA and related regulatory agencies

The main PUDFA goal

You give us a a lot of money and we will approve 90% of applications within 10 months

First biosimilar drug approved by FDA

Zarxio (filgrastim-sndz) in 3/2015

Biologics control act

1901 law regulating vaccines, serums and antibodies

Food and drug act

1906 law preventing the marketing of adulterated or misbranded drugs

Food, drug and cosmetic act

1938 law that required FDA to confirm product safety before it got on the market

Durham-Humphrey amendment

1951 law that allowed certain medications to be dispensed with a prescription only

Kefauver-Harris amendment

1962 law required companies to demonstrate drug product efficacy, safety before approval. Also FDA was given authority to oversee drug advertising

Food and drug administration modernization act

1997 law that allowed fast-tracking of drugs and biologics

Food and drug administration amendments act

2007 law that gave FDA ability to impose a risk evaluation and mitigation strategies (REMS)

Food and drug administration safety and innovation act

2012 act that allowed FDA to ask for user fees for generic drugs and biosimilars + plus breakthrough designation

FDA's 2015 budget

4.74 billion, with 2.16 billion additional coming from user fees

Definition of a drug by the food,drug and cosmetic act

Articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or any other animal, article being something other than food intended to affect the structure or function of the body

FDA is under?

Department of health and human services (DHHS)

FDA regulates what types of products?

Food, dietary supplements, cosmetics, vet products, drugs, med devices, biologics, tobacco, vaping

FDA's Budget Cycle

Oct 1st to September 30

Statute vs regulation vs Guidance

Statute is a law passed by congress, regulation is a rule issued by a federal agency, guidance is the FDA's current thinking on its regulations