fda overview

8/17/2019 FDA Overview

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U.S. Food and Drug AdministrationU.S. Food and Drug Administration

By: Cameron Bornholm, Angela Jenkins,

and Cherelle Waters


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I. What is the FDA?I. The job of the FDA

II. Who makes up the FDA

III. FDA’s mission statement

II. Brief History of the FDA

III. Sectors of the FDA

I. !ecent !eca""s an# A"erts


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The $.S. Food and Drug Administration (FDA) is an

a%ency of the $S Department of Hea"th an# Human

Ser&ices that is responsib"e for the safety re%u"ation of'

◦ most types of foo#s

◦ #ru%s

◦ &accines◦ b"oo# pro#ucts

◦ me#ica" #e&ices

◦ #ietary supp"ements

◦

bio"o%ica" me#ica" pro#ucts◦ ra#iation(emittin% #e&ices

◦ &eterinary pro#ucts

◦ cosmetics


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he FDA is the U.S. !o"ernment agen#y thato"ersees most $oods and medi#al %rodu#ts.

&ts 'o is to make sure that:

foo# is safe) hea"thy) an# c"ean me#icines an# me#ica" #e&ices are reasonab"y safe

an# effecti&e cosmetic pro#ucts are safe anima" foo#s an# #ru%s are safe

foo# an# me#ica" pro#ucts ha&e proper "abe"s


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he FDA is ithin the De%artment o$ *ealth and

*uman Ser"i#es and #onsists o$ nine di"isions:

◦ Center $or Biologi#s +"aluation and esear#h

◦ Center $or De"i#es and adiologi#al *ealth

◦ Center $or Drug +"aluation and esear#h

◦ Center $or Food Sa$ety and A%%lied -utrition

◦ Center $or eterinary /edi#ine

◦ -ational Center $or o0i#ologi#al esear#h

◦ 1$$i#e o$ Chie$ Counsel

◦ 1$$i#e o$ the Commissioner

◦ 1$$i#e o$ egulatory A$$airs


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he FDA #onsists o$ em%loyees dran $rom aealth o$ s#ien#e and %uli# health %ro$essions

iologists, %hysi#ians, #hemists, iomedi#alengineers, to0i#ologists, %harma#ologists,"eterinarians, and s%e#ialists in the %uli#health edu#ation and #ommuni#ation

FDA em%loys a%%ro0imately 2,333 %eo%le hoork in lo#ations around the United States


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o %romote and %rote#t the %uli# health yhel%ing sa$e and e$$e#ti"e %rodu#ts rea#h themarket in a timely manner

o monitor %rodu#ts $or #ontinued sa$etya$ter they are in use y the %uli#

o hel% the %uli# get the a##urate, s#ien#e4

ased in$ormation needed to im%ro"e health


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Food and Drugs A#t o$ 5236 "ai# the foun#ation for themo#ern foo# an# #ru% "a*

Safety of foo# a##iti&es *as pre&ious"y teste# by the78oison S9uad

In +,-) it *as #isco&ere# that the #ru% Sul$anilamide containe# a poison *hich ki""e# +/ peop"e The pre&ious "a* #i# not re0uire testin% for #ru% safety

before puttin% them on the market. The ne1t year Congress %assed the Federal Food,

Drug, and Cosmeti# ;a. FDA combines "a* an# science to protect consumers


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Food Drugs Biologi#s, Blood, and a##ines

Animal < eterinary Cosmeti#s /edi#al De"i#es adiation4+mitting 8rodu#ts Comination 8rodu#ts


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FDA monitors the nation’s foo# supp"y bymakin% sure that a"" in%re#ients use# in foo#sare safe) an# that foo# is free of contaminants "ike #isease(causin% or%anisms) chemica"s) or other harmfu" substances

23eat 4 pou"try pro#ucts are re%u"ate# by $SDA2

The a%ency must appro&e ne* foo# a##iti&esbefore they can be use# in foo#s

FDA monitors the safety of #ietary supp"ements an# the content of infant formu"as

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Prescription drugs◦ Undergo New Drug Application Process

◦ Orange Book lists all FDA approved prescriptiondrugs, updated monthly

Over-the-counter drugs◦ Benets outweigh the risks

◦ O!" drug monographs cover accepta#leingredients, doses, $ormulations, testing, and

la#eling◦ Products con$orming to O!" monograph may go

on market without pre-approval $rom FDA

http://www.fda.gov/cder/handbook/nda.htmhttp://www.fda.gov/cder/handbook/nda.htm


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O!" drugs range $rom acne drug productsto weight control drug products

Potential $or improper use must #e low,consumer can use them $or sel$- diagnosedpro#lems, health practitioners are notneeded $or sa$e and e%ective use

O!" drug monographs contain in$ormation

on accepta#le ingredients, doses,$ormulations, la#eling, and testing


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FDA is responsib"e for ensurin% safety of our nation’s b"oo#y supp"yan# re%u"ation of &accine pro#ucts

B"oo# Action 5"an initiate# in +,, to increase the effecti&eness of itsscientific an# re%u"atory actions

◦

Addresses areas such as emergency operations, response toemerging diseases, and updating o$ regulations&

6"inica" #e&e"opment of &accines fo""o* the same %enera" path*ayas #ru%s

accine appro&a" re0uires a#e0uate pro#uct "abe"in% for hea"th carepro&i#ers to un#erstan# proper use

Accor#in% to the 6D6 &accines has re#uce# pre&entab"e infectious#iseases tremen#ous"y


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FDA re%u"ates #ru%s an# #e&ices use# for

anima"s 7both pets an# anima"s that pro#uce foo#8 Before manufacturers can market anima" #ru%s

7inc"u#in% #ru%s use# in anima" fee#s8) they must%ain FDA appro&a" by pro&i#in% proof of theirsafety an# effecti&eness

eterinary me#ica" #e&ices #o not ha&e to be pre(appro&e# by FDA before marketin%) but they sti""

must be safe) effecti&e) an# proper"y "abe"e#

9i&estock #ru%s are e&a"uate# for their safety tothe en&ironment an# to the peop"e *ho eat theanima" pro#ucts.

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'(ad "ow Disease) Progressively neurological disease known as

transmissi#le spongi$orm encephalopathy*s FDA pu#lished two rules in + and .//0

to protect animals and consumers againstB12 #y prohi#iting the use o$ mostmammalian protein in the manu$acture o$animals $eeds given to ruminant animalsand #y removing high-risk materials $rom allanimal $eeds


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3n .//+ the FDA re4uested that livestockproducers keep $ood produced $rom animalclones and their o%spring out o$ $ood supply

FDA had conducted thorough evaluation onsa$ety o$ $ood $rom these animals andanimal health risks◦ 3n 5anuary .//0 the FDA conrmed that meat and

milk $rom cow, goat, and pig clones are sa$e


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6articles intended to #e ru##ed, poured,sprinkled, or sprayed on, introduced into, orotherwise applied to the human #ody&&&$orcleansing, #eauti$ying, promoting

attractiveness, or altering the appearance67FD8" Act, sec& ./+9i:;&

http://images.google.com/imgres?imgurl=http://www.100makeup.com/100makeup/mascara.jpg&imgrefurl=http://www.100makeup.com/100makeup/makeup%20expiry%20date.htm&h=300&w=400&sz=24&hl=en&start=4&usg=__P7OCjFx7Os-sKySNsvC-uwMzGCw=&tbnid=QCnVvp3DAhcLQM:&tbnh=93&tbnw=124&prev=/images?q=mascara&gbv=2&hl=en


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!he two laws pertaining to "osmetics are<◦ Federal Food, Drug, 8 "osmetic Act

◦ Fair Packaging and =a#eling Act

FDA*s legal authority over cosmetics is di%erent $rom other

products regulated #y the agency, such as drugs, #iologics,and medical devices&

◦ "osmetic products and ingredients are not su#>ect to FDApremarket approval authority, with the e?ception o$ coloradditives& * Puts the obligation on the corporation

◦ FDA may pursue en$orcement action against violative

products, or against rms or individuals who violate thelaw&


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"osmetics $rom other countries are su#>ectto review #y the FDA at the time o$ entry atU1 "ustoms

"osmetic companies are not re4uired to leany in$ormation with the FDA, #ut areencouraged to le a "osmetic Product3ngredient 1tatement with the @oluntary"osmetic egistration Program

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A medi#al de"i#e is an object *hich is usefu" for#ia%nostic or therapeutic purposes.

http://en.wikipedia.org/wiki/Image:Blood_Glucose_Testing.JPG


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De"i#es at FDA◦ 5ro&i#es a search pro%ram to obtain info on any #e&ice

appro&e# by the FDA

+0am%les o$ some medi#al de"i#es are:◦

Breast Imp"ants◦ 6ontact 9enses

◦ 9asers for 9asik :ye Sur%ery

◦ 9aboratory Tests

◦ Home Testin% ;"ucose

5re%nancy

http://www.fda.gov/CDRH/LASIK/animation/animation-play.html','animation','400','400','no


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/edi#al &maging◦ 3e#ica"


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The FDA Center $or De"i#es and adiologi#al *ealth (CD*) co""aborates *ith the Con$eren#e o$ adiation Control 8rogramDire#tors (CC8D) in a uni0ue fe#era"(state partnership tocharacteri=e the ra#iation #oses patients recei&e an# to #ocumentthe state of the practice of #ia%nostic ra#io"o%y.

:ach year >:


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The FDA protects the pub"ic from unnecessarye1posure to ra#iation from e"ectronic pro#ucts

5ro#ucts inc"u#e' micro*a&e o&ens) ce"" phones)

"asers) 3!I machines) 1(ray e0uipment) me#ica"u"trasoun# machines) an# many other consumer)in#ustria") an# me#ica" pro#ucts

http://images.google.com/imgres?imgurl=http://www.sportstek.net/images/qacp+.gif&imgrefurl=http://www.sportstek.net/qacp+.htm&h=235&w=349&sz=31&hl=en&start=11&usg=__hZNksd46jP8BtuPPw7_vNSy-XLI=&tbnid=BbZGwKWbqZVOeM:&tbnh=81&tbnw=120&prev=/images?q=ultrasound+machine&gbv=2&hl=en


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6abinet


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Cell 8hones

◦ FCC ensures that a"" *ire"ess phones so"# in the $S fo""o*safety %ui#e"ines that "imit ra#iofre0uency 7!F8 ener%y. FDA monitors the hea"th effects of *ire"ess te"ephones. :acha%ency has the authority to take action if a *ire"ess phone

pro#uces ha=ar#ous "e&e"s of !F ener%y.◦ FDA #eri&es its authority to re%u"ate *ire"ess te"ephones

from the !a#iation 6ontro" pro&isions of the Federal Food,Drug, and Cosmeti# A#t 7ori%ina""y enacte# as the!a#iation 6ontro" for Hea"th an# Safety Act of +,@8.

◦

FCC #eri&es its authority to re%u"ate *ire"ess te"ephonesfrom the -ational +n"ironmental 8oli#y A#t o$ 5262 7>:5A8 an# the ele#ommuni#ations A#t o$ 5226


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De$inition o$ a #omination %rodu#t in#ludes:◦ A pro#uct comprise# of t*o or more re%u"ate#

components that are combine# to pro#uce one entity

◦ T*o or more separate pro#ucts packa%e# to%ether as a

unit an# comprise# of #ru% an# #e&ice pro#ucts) #e&icean# bio"o%ica" pro#ucts) or bio"o%ica" an# #ru% pro#ucts

◦ A #ru%) #e&ice) or bio"o%ica" pro#uct that is packa%e#separate"y) but is inten#e# to be use# *ith an appro&e#in#i&i#ua""y specifie# re%u"ate# pro#uct


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+0am%les: Trans#erma" patch for attention #eficit hyperacti&e

#isor#er 7ADHD8 7Apri" +/) //@8 Trans#erma" 5atch for Depression 7February ) //@8 Inha"e# Insu"in 6ombination 5ro#uct for Diabetes

7Canuary ) //@8 Denta" Bone ;raftin% 3ateria" *ith ;ro*th Factor

Sur%ica" 3esh *ith Antibiotic 6oatin%


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FDA *orks *ith manufacturers *hen prob"ems arise

If that fai"s) FDA asks manufacturer to reca"" the

pro#uct *hi"e fe#era" marsha"s sei=e the pro#ucts7if the reca"" is not &o"untary8

FDA can ask the courts to prosecute those in

&io"ation of the "a*


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Fro=en cooke# musse" pro#ucts ma#e by BantryBay Seafoo#s) importe# from Ire"an#) may becontaminate# *ith a=aspiraci# to1ins

+o= bo1es of ani""a Wafers *ith a co#e #ate of

/-//,A) may contain un#ec"are# soy Who"e Foo#s 3arket' -@E r%anic :&ery#ay

a"ue 5opcorn) 9i%ht"y Sa"te#) may containun#ec"are# mi"k in%re#ients

5harmacy a"ert in Ba"timore) consumers may ha&erecei&e# e1pire# or suspecte# counterfeit #ru%s


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FDA e#site www&$da&gov

ikipedia e#site www&wikipedia&com

fda overview

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