Transcript FDA Overview

Regulatory
Big Brother of Biotechnology
Role of FDA
FDA was designed to promote and protect
the public’s health
Food and Drug Cosmetic Act first passed
in 1906 to prevent the sale of
unacceptable food and drugs
How do they know when a drug is safe for
use?
Role of FDA
Minimum requirement for release of a drug
is that it has to safe and effective
– There are always risks and side effects
The FDA has to determine when the
benefits out weigh the risks
– Vaccines and life threatening diseases
– Clinical trials: when is enough enough?
Thalidomide incident
Center for Drug Evaluation &
Research
CDER
Group which assures the safety and
effectiveness of drugs available in the
U.S.
Monitors for adulterated or contaminated
drugs
– Adulterated: drug or food produced by
methods which do not conform to cGMP
Center for Biologics Evaluation and
Research
CBER
Reviews applications for new biologics
produced from microbes and viruses
– Examples: vaccines, allergens, monoclonal
antibodies
Regulates all aspects of the process from
mfg. to QC, to labeling and advertising
Center for Devices & Radiologic
Health
CDRH
Regulates medical devices and some in
vitro diagnostic kits
Examples of devices:
– Pace maker, ultrasonic cleaners for cleaning
medical instruments, insulin monitors,
thermometers
Examples of in vitro diagnostic kits
– CK-MB kits
Center for Food Safety & Applied
Nutrition
Protects and promotes health & economic
interests by ensuring that foods are safe,
nutritious, and honestly labeled
Also oversees cosmetics
Does the FDA oversee Blood
Donations?
Yes, they do
What testing or procedures do they
require?
– Donor screening: medical history
– Blood testing: for HIV, Hep, Syphilis, etc
– QC SOPs for drawing, testing, processing,
inventory control and lot traceability
FDA Actions
Facility Inspections
483: inspector’s note documenting a
deficiency
– Not following procedure
– Incomplete records
Warning letter: written letter citing cGMP
violations. Requires a written response of
corrective actions to be implemented.
FDA Actions
If a company does not comply with FDA
requests the FDA can do any and all of the
following:
– Take the product(s) off of the market
– Sue and or arrest executives
– Detain imports / exports
FDA cannot do nothing when they know
there are issues at a company