-Quiz:

Introductory lecture
Organs on a chip
Guest lecture

Short answer, a few sentences

Can use books, written notes
Regulatory Affairs: an Introduction

Regulatory Affairs is a legal system, behind science by years. The whole point is SAFETY.

Even foods vary from country to country-- Skittles vary in taste due to dyes

Most items, services, and functions are regulated

Regulations are often considered a costly and unnecessary, sometimes the bad guys.
Medical arena is the most regulated industry in the world.

Biomedical scient + law = Regulatory Affairs

Regulatory affairs the desire of governments to protect public heatlh by controlling the safety
and efficacy of. of products in areas including pharmaceuticals, verterinary medicines, medical
devices, pesticides, agrochemicals, cosmetics and complementary medicines

Sulfanilamide disaster - 1937

Sulphathiazole - 1941
Thalidomide -1958-1960
1932-1972 Tuskagee syphilis experiment
Acres of Skin 1998
1963 - Jewish Chronic Disease hospital injects live human cancer cells into 22 ill patients
to see if cells would live
1964 - Willowbrook State Hospital injected Hep virus into mentally retarded children

The FDA is the oldest consumer protection agency.

1906 Pure Food and Drugs Act (Wiley Act)
1911 US vs Johnson, Supreme Court rules that 1906 Act did not prohibit false therapeutic
claims
1912 Sherley amendment
1914 US vs Lexington Mill and Elevatory Co.
1914 the Harrison Narvoctic Act
1924 US v. 95 Barrels Alleged Apple Cider Vinegar
1927 Food Drug and Insecticide Org
1930 FDIA is renamed Food and Drug Administration
Why so complex?
Compliance is the maintenance of documentation, systems and quality controls to ensure that
manufacture of the product meets the specifications provided in the submission

A submission assumes that data presented is indicative of ongoing production- hence maintains
consistency

Evolution - regulations evolve over time,

Redundancy do not get remove, instead get built on. Move painfully slow

Interpretation - regs open to interp. by those who enforce them and by those who use them.
Consider the right to have and bear arms

Scientific progress - regs are several years behind science and struggle to catch up

Politics - regulatory agencies may be political appointees, regulations are open to pub scrutiny

Fear no one wants to be that person who approved Thalidomide

PIP Scandal

Hip implants - implants can be removed, but not encapsulated fragments --DePuy

Transvaginal Mesh

Whenever you talk about the biocompatibility of a biomaterial, it has to be implantation

area specific.

Standard is a document that provides requirements, specifications, guidelines, that can be used
consistently to ensure that materials, products, processes, and services are fit for their purpose
NOT REGULATIONS, NOT REQUIRED

what are stents-open up blood vessel

drug stent -

FDA perform onsite inspections

Europe
Prior to 83, drugs had to be reviewed by each country indep.

MUST state purpose

Healthcare is one of the most regulated industries in the world
US is comparatively easy w/reg

FDA

protect public health by assuring that food is safe, drugs and medical devices intended
for human use are safe and effective
protect the public from electronic product radiation
ensuring cosmetics and dietary supps are safe and prop. labeled
reg. tobacco products
advancing the public health by helping to speed product innov.
extend to 50 states, dc. puerto rico, guam, virgin islands, american samoa, other us
territories
FDA is a fed agency w capacity and resources for armed responses

campus in Maryland
consolidated campus
cross functional teams
better communication
significant work from home

device submiss types

traditional
special
abbrev

Class 1:
simple, lowest risk, well understood or simple tech, often exempt from premarket review

C2:
slightly more complex

C3: must have clinical trials, most complex, highest risk

PMA applies to class III, classific. acc. to CFR, if device found not Substantially equiv.,
a new device for which no substantially equivalent basis exist, needs proof of reasonable
assurance of safety/effectiveness

IDE is a submission process allowing FDA to approve clinical investigation of devices,

exempt from some regulatory req.
for when they want to go straight to clinical trials

510 K only allowed two sets of questions, if you dont pass then, youre done
three types
trad for any class i ii iii
spec. may be used for submissions for devices similar to something already on the
market
abbrev

approval for drugs

preclin. reasear
bench top testing cultures to animal testing
IND testing in humans
phase I human trials 20-80 healthy volunteers, 1 yr
phase ii 100-300 volunteers w disease being studied, two yrs
phase 1000-3000 volunteers w/spec dis., about three yrs

IND only allows you to test on people, doesnt give you anything else
needs animal pharmacology and toxicology studies, manufacturing information, and
clincal protocos and investigator information

WHat biological products does FDA regulate?

allergenic extracts blood and blood comp.
gene therapy prod devices and test kits
human tissue and cellular prod. used in trans
vaccines

others
monoclonal antibodies mesigned as targeted therapies in cancer and other diseases

combination products approval pathway

combine drugs, devices, and or bio products

how do companies deal with restrictions and costs of RA:

of 10000 employees, FDA taks four people to police food labels

do they control doctors?

drugs-if drug is on the market, a doctor can and often will prescribe for off label use

FDA even followed their own people and threatened them

you cannot market anything w/o fda approval, once it is on the market, doctors can do
anything with it

actual cost of submission is minor in comparison to the inherent staff, resources, and
trial costs
only 10% will get through NDA

challenges facing CDRH

rapid tech changes
increasing complexity of devices
public demand for more ccontrol over healthcare (root)
global marketplace and global regulation
shrinking staff numbers

google MDUFA