Personal Information
Organization / Workplace
Greater San Diego Area United States
Occupation
Principal
Industry
Legal
Website
www.fdacounsel.com
About
Michael A. Swit, Esq., Principal in the San Diego-based Law Offices of Michael A. Swit, is a highly-experienced food & drug law attorney who has been been addressing critical FDA legal issues since 1984. His vast experience includes serving as the chief regulatory lawyer at Illumina, Inc., the world's leading developer of gene sequencing technology; as general counsel and secretary of Par Pharmaceutical, a prominent generic drug company and stints as Special Counsel in the FDA Law Practices of Duane Morris LLP, Heller Ehrman, and McKenna & Cuneo (now Denton's).
Mr. Swit has taught and written on a array of subjects relating to FDA law, regulation and related commercial activities,
Tags
fda
clinical study
clinical trial
warning letter
anda
clinical investigation
park doctrine
irb
clinical site
inspection
gmp
ftc
enforcement
nda
compliance
biosimilar
generic drug
clinical investigator
510(k)
gcp
483
primary mode of action
fdasia
social media
risk evaluation and mitigation strategy
pmoa
informed consent
advertising
sponsor
interchangeability
pma
drug
waxman-hatch
505(j)
injunction
aip
seizure
accelerated approval
clinical trial registries
medical device
hatch-waxman
office of generic drugs
criminal prosecution
consent decree
request for designation
fdaaa
adverse events
financial disclosure
ind
505(b)(2)
rems •
patent certification
unmet medical need
rfd
combination products
lead center
generic drug scandal
bpcia
internet
cdrh
bioequivalence
pediatric research equity act
505(b)(1)
exclusivity
fast track
vioxx
office of criminal investigations
hamburg
application integrity policy
device/biologic
drug/device
clinical trials results database
clinicaltrials.gov
facebook
substantial equivalence
brief statement
best pharmaceuticals for children act
bpca
prea
federal food drug and cosmetic act
breakthrough therapy
phase 4 study
criminal liability
drug/biologic
cder
surrogate endpoint
ide
procedures
sops
marketing
twitter
off-label
intended use
fair balance
highly similar
fdama
user fees
pediatric exclusivity
office of combination products.
ocp
safety
reimbursement
substituion •
naming •
30-month stay
available therapy
gain
existing therapy
clinically significant endpoints
substantial improvement
preliminary clinical evidence
serious condition
surrogate marker
intermediate clinical endpoint
meaningful therapeutic benefit
severely debilitating
life threatening
subpart e
responsible corporate officer
collateral consequences
medical devices
first amendment
caronia
youtube
guidance
federal trade commission act
patent extension
otc drug monograph
roche v bolar
ogd
biologics price competition and innovation act
dietary supplement
qui tam
oci
felony
close out
exclusion
mdufma
cber
spoos
21 cfr 54
investigation new drug
investigational device exemption
tumblr
false claims act
interchangeable
premarket notification
nse
sepp
follow-on protein product
biologic
follow-on-biologic
brief summary
ivd
smda
orphan drug exclusivity
therapeutic equivalence
anda exclusivity
drug price competition and patent term restoration
premarket approval application
paper nda
pdufa
elements to assure safe use
etasu
orphan drug designation
planning
paragraph iv
rx-to-otc switch
orange book
rems
subsequent entry protein product
health claims
misdemeanor
prohibited acts
section 704
disgorgement
bla
significant payments of other sorts
hhs
21 cfr 50
valid scientific evidence
pearson
sorrell
central hudson
de novo 510k
biosimilars
untitled letter
labeling
investigational plan
mobile medical applications
digital health
audit
eir
class iii
seb
fob
marketing and advertising
health care program exclusion
competent and reliable scientific evidence
amarin
correcting ugc
user generated content
scientific exchange
reminder ad
in vitro diagnostic
social media space limitation guidance
social media marketing
internet marketing
reference product
characterization
anda suitability petition
reference listed drug
rld
market exclusivity
otc drug review
dtc advertising
unique device identifier
udi
refusal to permit inspection
wyeth v levine
drug safety
protocol assistance
office of orphan product development
effectiveness
pediatric
center for medicare and medicaid services
cms
505(b)
351(k)
nutrient content claim
structure and function claims
crisis
disclosure
sec
sarbanes-oxley
rco
recall
combination product
abney
suthers
ae
1572
investigational new drug
ugc
commercial speech
crisis management
indemnification
se
biogeneric
generic
ethics committee
quality system
ldt
ruo
promotional review committee
carse
misbranding
superiority claims
unapproved use
clinical
sponsored scientific and educational activities
help seeking ad
adequate provision
21 cfr 202.1
establishment inspection report
unapproved
180-day exclusivity
first to file
generic drug enforcement act
citizen petitions
qualifying pathogens
qidp
qualified infectious disease product
generating antibiotic incentives now
gain act
rare pediatric drug voucher
food & drug administration safety & innovation act
cmc
grants
henry waxman
orphan drug
who •
usan •
ndi notice
dshea
structure/function claim
qualified health claim
new dietary ingredient
añada
nada
vitamins
regulatory
misbranded
mccall
caremark
securities litigation
deport
caraco
kv
prosecution
food drug & cosmetic act
purdue frederick
dotterweich
oai
vai
nai
import alert
purdue pharma
dia
covered study
good clinical practice
world health organization
icmje
continuing review
belmont report
henry beecher
declaration of helsinki
nuremberg code
gelsinger
clinical research
sae
restricted device
opdp
sunshine act
502(n)
502(q)
502(r)
clinical decision support software
alivecor
mhealth
due diligence
de novo
cta
ich
quality
clia
laboratory developed test
research use only
adulteration
orphan drug act
facebook share widget tasigna
major statement
data integrity
validation
training
records
prc
pom wonderful
adequate substantiation
ftca
whistleblower
adequate directions for use
metatags
2253
minimizing risk
overstating efficacy
clinical practice guidelines
good reprint practices
unsolicited requests
issea
pharmacovigilance
sameness
nih
internal audit
transparency
transfers of value
tov
teaching hospitals
open payments
health care provider
hcp
covered recipient
covered product
applicable manufacturer
affordable care act
pre-approval promotion
software
pds
rta
refuse to accept
abbreviated 510(k)
special 510(k)
pre-submission
indication
predicate device
not substantially equivalent
pharmaceutical
mou
harmonization
gatt
tea rule
otc drugs
1962 drug amendments
nce-1
facility fee
gdufa
biosimilarity
orrin hatch
drug efficacy study implementation
design
waiver
gail gillenwater
eloxatin
l
e
arthrotec
21 cfr 300.50
office of drug evaluation
factorial study
fixed dose combination drugs
fda review
substantial evidence
complete response letter
pre-bla meeting
pre-nda meeting
special protocol assessment
margaret hamburg
risk management
civil penalties
tax credits
nord
inn •
biologics price competition and innovation act •
351(k) •
351(a)
generic biologic
subsequent entry biologic
minor species
major speciies
abbreviated new animal drug application
new animal drug application
qualified health claims
sec disclosure
sox
class i
correction
debarment
ffdca
market withdrawal
clinical trial agreement
material transfer agreement
mta
3355
3354
bias
record retention
assent
legally authorized representative
lar
international conference on harmonization
ictrp
contract
ifc
liability
expedited review
human subject protection
common rule
therapeutic misconception
acrp
global
specific use
general use
21 cfr 801.4
clearance
promotion
investigator
mma
naming
qsr
class ii
mlr
cfl
facebook marketing
omitting risk information
journal ads
disseminating scientific information
consumer brief summary
biomedical
startup
aseptic processing
manufacturing
fresenius
akorn
principal investigator
good manufacturing practice
barr case
establishment registration
samples
482
drug listing
rebecca k. wood
scott gottlieb
pre-rfd
depomed
rare disease day
global genes
national organization for rare disorders
novel drug
200000
incidence
prevalence
#orphandrugact
#raredisease
#orphandrug
carve out
520(o)
multiple function
21st century cures act
cds
patient decision support software
subject
nomenclature
pv
w.h.o.
usp
u.s. adopted name council
proper name
core name
suffix
brand name
non-proprietary name
corporate culture
audits
compliance officer
google ads
space limited ad
udell
friedman
oig
continuing medical education
predissemination review
civil money penalties
505b
risk guidance
fopp
sebi
salami slicing
clinical superiority
bsufa
conflicts of interest
institutional review board
third party posts
social media monitoring
social media strategy
national advertising division
nad
endorsements
deception
relator
metadata
forum
chat rooms
blogs
space limitation
tweet
unsubstantiated
benefit/risk
nccn
medical reference text
scientific journal
medical journal
section 401
independence
clinical support
texts
reprints
industry
pre-dissemination review
television
tv ad
health seeking ad
direct-to-consumer
balance
risk
pre-de novo submission meeting
apotex
ranbaxy
genzyme
mensing
changes being effected
cbe
state substitution laws
rp
food
cdc
kefauver-harris amendments
1938
elixir sulfanilmide
the jungle
upton sinclair
pure food & drug act
virus toxin law
biologics control act
1902
harvey wiley
new drug application
cpg 130.300
aegerion
blinding
fpla
animal medicinal drug use clarification act
amduca
medicated feed
adufa
minor use/minor species
mums
investigational new animal drug
inad
201(v)
onade
office of new animal drug evaluation
major/minor uses
major/minor species
animal drug
priority review
pre-approval inspection
supplement
general/specific use
21 cfr 812.7
non-inferiority
conformity standard
significant risk device
device classification
201(h)
safe medical devices act
commissioner
center for devices & radiological health
cardiac lunch
cardiovascular device
technological characterization
device modification
pre-de novo submission
modifications
changes
office of device evaluation
ode
scp
standing committee on the law of patents
first to invent
european patent convention
epc
world trade organization
wto
world intellectual property organization
wipo
patent cooperation treaty
pct
nafta
trade-related aspects of intellectual property
trips
uruguay rounds
intellectual property
paris convention
treaty
mutual recognition agreement
mra
memorandum of understanding
iso
international standards organization
global harmonization task force
ghtf
congress
9001
13485
801
export
import
formularies
settlements
gratuity
dingell
desi
essential to approval
3-year exclusivity
nce
new chemical entity
reformulation
brand vs. generic
omnitrope
qbr
question based review
food effect
in vitro
in vivo
pharmaceutical equivalents
bioavailability
rtr
refuse-to-receive
crl
regulatory science
active pharmaceutical ingredient
api
pastor
prior approval supplement
dmf
generic drug user fee act
ftf
patent restoration
humanitarian device exemption
hde
deferral
pediatric assessment
pediatric rule
dan troy
andrew von eschenbach
lester crawford
food & drug administration amendments act of 2007
private right of action
failure to warn
impossibility preemption
implied conflict preemption
products liability
phenergan
demerol
preemption
fdli
perez v nidek
fraud
code of conduct
ethics
biologics licensing application
california institute for regenerative medicine
cirm
california stem cell research and cures act
proposition 71
stem cell
chemistry manufacturing and controls
sawp
scientific advice working party
scientific advice
small-to-medium size enterprise
sme
rtf
refuse to file
advisory committee
spa
eop
end of phase 2
toxicology
preclinical
lucentis
macugen
josh sharfstein
ophthalmic
medication guides
post-approval studies
abbey meyers
marlene haffner
rare disorder
rare disease
any given patient •
bpcia •
351(a) •
bla •
generic biologic •
fda •
risk evaluation and mitigation strategy •
interchangeability •
sepp •
seb •
subsequent entry protein product •
gain •
existing therapy •
clinically significant endpoints •
substantial improvement •
preliminary clinical evidence •
serious condition •
breakthrough therapy •
fast track •
phase 4 study •
fdasia •
surrogate marker •
intermediate clinical endpoint •
surrogate endpoint •
meaningful therapeutic benefit •
severely debilitating •
life threatening •
subpart e •
accelerated approval •
unmet medical need •
available therapy •
usan
any given patient
substituion
functional food
nutritional labeling
nlea
mineral
nutrition
ndi
security
raps
affairs
management
adulterated
nasdaq
nyse
21 cfr 806
field alert
recall classification
stock recovery
effectiveness checks
health hazard assessment
drugs
suspend
debar
civil litigation
charlie chang
parenttoolbox
mylan
duty to investigate
attorney fees
non-compliance
quality assurance program
embargo
u.s. attorney
doj
301
inspections
sponsor/investigator
drug eluting stent
biologic/drug
21 cfr 56
good clinical practices
drug information association
irbs
msa
master services agreement
contract research organiation
cro
cda
confidentiality
minimize
disqualification
21 cfr 312.70
slovenia
emea
eu clinical trial directive
eu
europe
e6
international
3674
who
acute myeloid leukemia
aml
gemtuzumab
mylotarg
central irb
coast irb
spitzer
india
indonésia
china
qualtiy
hipaa
investigation device exemption
law
liking
links
share widget
pharmawall
largo
misbrand
free speech
advamed code
general/specific
pre-clearance
wlf
washington legal foundation
scrutiny
speech
western states medical
false claims
ddmac
clinical trials
regulation
exempt
202.1
1571
substitution
gpha
biologics
outsourcing
207
513(f)(2)
ema
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Presentations
(224)Documents
(9)Likes
(2)FDA Regulation of Promotion & Advertising -- Part 5: Social Media & Internet
Michael Swit
•
6 years ago
The 510(k) Process
Michael Swit
•
6 years ago
Personal Information
Organization / Workplace
Greater San Diego Area United States
Occupation
Principal
Industry
Legal
Website
www.fdacounsel.com
About
Michael A. Swit, Esq., Principal in the San Diego-based Law Offices of Michael A. Swit, is a highly-experienced food & drug law attorney who has been been addressing critical FDA legal issues since 1984. His vast experience includes serving as the chief regulatory lawyer at Illumina, Inc., the world's leading developer of gene sequencing technology; as general counsel and secretary of Par Pharmaceutical, a prominent generic drug company and stints as Special Counsel in the FDA Law Practices of Duane Morris LLP, Heller Ehrman, and McKenna & Cuneo (now Denton's).
Mr. Swit has taught and written on a array of subjects relating to FDA law, regulation and related commercial activities,
Tags
fda
clinical study
clinical trial
warning letter
anda
clinical investigation
park doctrine
irb
clinical site
inspection
gmp
ftc
enforcement
nda
compliance
biosimilar
generic drug
clinical investigator
510(k)
gcp
483
primary mode of action
fdasia
social media
risk evaluation and mitigation strategy
pmoa
informed consent
advertising
sponsor
interchangeability
pma
drug
waxman-hatch
505(j)
injunction
aip
seizure
accelerated approval
clinical trial registries
medical device
hatch-waxman
office of generic drugs
criminal prosecution
consent decree
request for designation
fdaaa
adverse events
financial disclosure
ind
505(b)(2)
rems •
patent certification
unmet medical need
rfd
combination products
lead center
generic drug scandal
bpcia
internet
cdrh
bioequivalence
pediatric research equity act
505(b)(1)
exclusivity
fast track
vioxx
office of criminal investigations
hamburg
application integrity policy
device/biologic
drug/device
clinical trials results database
clinicaltrials.gov
facebook
substantial equivalence
brief statement
best pharmaceuticals for children act
bpca
prea
federal food drug and cosmetic act
breakthrough therapy
phase 4 study
criminal liability
drug/biologic
cder
surrogate endpoint
ide
procedures
sops
marketing
twitter
off-label
intended use
fair balance
highly similar
fdama
user fees
pediatric exclusivity
office of combination products.
ocp
safety
reimbursement
substituion •
naming •
30-month stay
available therapy
gain
existing therapy
clinically significant endpoints
substantial improvement
preliminary clinical evidence
serious condition
surrogate marker
intermediate clinical endpoint
meaningful therapeutic benefit
severely debilitating
life threatening
subpart e
responsible corporate officer
collateral consequences
medical devices
first amendment
caronia
youtube
guidance
federal trade commission act
patent extension
otc drug monograph
roche v bolar
ogd
biologics price competition and innovation act
dietary supplement
qui tam
oci
felony
close out
exclusion
mdufma
cber
spoos
21 cfr 54
investigation new drug
investigational device exemption
tumblr
false claims act
interchangeable
premarket notification
nse
sepp
follow-on protein product
biologic
follow-on-biologic
brief summary
ivd
smda
orphan drug exclusivity
therapeutic equivalence
anda exclusivity
drug price competition and patent term restoration
premarket approval application
paper nda
pdufa
elements to assure safe use
etasu
orphan drug designation
planning
paragraph iv
rx-to-otc switch
orange book
rems
subsequent entry protein product
health claims
misdemeanor
prohibited acts
section 704
disgorgement
bla
significant payments of other sorts
hhs
21 cfr 50
valid scientific evidence
pearson
sorrell
central hudson
de novo 510k
biosimilars
untitled letter
labeling
investigational plan
mobile medical applications
digital health
audit
eir
class iii
seb
fob
marketing and advertising
health care program exclusion
competent and reliable scientific evidence
amarin
correcting ugc
user generated content
scientific exchange
reminder ad
in vitro diagnostic
social media space limitation guidance
social media marketing
internet marketing
reference product
characterization
anda suitability petition
reference listed drug
rld
market exclusivity
otc drug review
dtc advertising
unique device identifier
udi
refusal to permit inspection
wyeth v levine
drug safety
protocol assistance
office of orphan product development
effectiveness
pediatric
center for medicare and medicaid services
cms
505(b)
351(k)
nutrient content claim
structure and function claims
crisis
disclosure
sec
sarbanes-oxley
rco
recall
combination product
abney
suthers
ae
1572
investigational new drug
ugc
commercial speech
crisis management
indemnification
se
biogeneric
generic
ethics committee
quality system
ldt
ruo
promotional review committee
carse
misbranding
superiority claims
unapproved use
clinical
sponsored scientific and educational activities
help seeking ad
adequate provision
21 cfr 202.1
establishment inspection report
unapproved
180-day exclusivity
first to file
generic drug enforcement act
citizen petitions
qualifying pathogens
qidp
qualified infectious disease product
generating antibiotic incentives now
gain act
rare pediatric drug voucher
food & drug administration safety & innovation act
cmc
grants
henry waxman
orphan drug
who •
usan •
ndi notice
dshea
structure/function claim
qualified health claim
new dietary ingredient
añada
nada
vitamins
regulatory
misbranded
mccall
caremark
securities litigation
deport
caraco
kv
prosecution
food drug & cosmetic act
purdue frederick
dotterweich
oai
vai
nai
import alert
purdue pharma
dia
covered study
good clinical practice
world health organization
icmje
continuing review
belmont report
henry beecher
declaration of helsinki
nuremberg code
gelsinger
clinical research
sae
restricted device
opdp
sunshine act
502(n)
502(q)
502(r)
clinical decision support software
alivecor
mhealth
due diligence
de novo
cta
ich
quality
clia
laboratory developed test
research use only
adulteration
orphan drug act
facebook share widget tasigna
major statement
data integrity
validation
training
records
prc
pom wonderful
adequate substantiation
ftca
whistleblower
adequate directions for use
metatags
2253
minimizing risk
overstating efficacy
clinical practice guidelines
good reprint practices
unsolicited requests
issea
pharmacovigilance
sameness
nih
internal audit
transparency
transfers of value
tov
teaching hospitals
open payments
health care provider
hcp
covered recipient
covered product
applicable manufacturer
affordable care act
pre-approval promotion
software
pds
rta
refuse to accept
abbreviated 510(k)
special 510(k)
pre-submission
indication
predicate device
not substantially equivalent
pharmaceutical
mou
harmonization
gatt
tea rule
otc drugs
1962 drug amendments
nce-1
facility fee
gdufa
biosimilarity
orrin hatch
drug efficacy study implementation
design
waiver
gail gillenwater
eloxatin
l
e
arthrotec
21 cfr 300.50
office of drug evaluation
factorial study
fixed dose combination drugs
fda review
substantial evidence
complete response letter
pre-bla meeting
pre-nda meeting
special protocol assessment
margaret hamburg
risk management
civil penalties
tax credits
nord
inn •
biologics price competition and innovation act •
351(k) •
351(a)
generic biologic
subsequent entry biologic
minor species
major speciies
abbreviated new animal drug application
new animal drug application
qualified health claims
sec disclosure
sox
class i
correction
debarment
ffdca
market withdrawal
clinical trial agreement
material transfer agreement
mta
3355
3354
bias
record retention
assent
legally authorized representative
lar
international conference on harmonization
ictrp
contract
ifc
liability
expedited review
human subject protection
common rule
therapeutic misconception
acrp
global
specific use
general use
21 cfr 801.4
clearance
promotion
investigator
mma
naming
qsr
class ii
mlr
cfl
facebook marketing
omitting risk information
journal ads
disseminating scientific information
consumer brief summary
biomedical
startup
aseptic processing
manufacturing
fresenius
akorn
principal investigator
good manufacturing practice
barr case
establishment registration
samples
482
drug listing
rebecca k. wood
scott gottlieb
pre-rfd
depomed
rare disease day
global genes
national organization for rare disorders
novel drug
200000
incidence
prevalence
#orphandrugact
#raredisease
#orphandrug
carve out
520(o)
multiple function
21st century cures act
cds
patient decision support software
subject
nomenclature
pv
w.h.o.
usp
u.s. adopted name council
proper name
core name
suffix
brand name
non-proprietary name
corporate culture
audits
compliance officer
google ads
space limited ad
udell
friedman
oig
continuing medical education
predissemination review
civil money penalties
505b
risk guidance
fopp
sebi
salami slicing
clinical superiority
bsufa
conflicts of interest
institutional review board
third party posts
social media monitoring
social media strategy
national advertising division
nad
endorsements
deception
relator
metadata
forum
chat rooms
blogs
space limitation
tweet
unsubstantiated
benefit/risk
nccn
medical reference text
scientific journal
medical journal
section 401
independence
clinical support
texts
reprints
industry
pre-dissemination review
television
tv ad
health seeking ad
direct-to-consumer
balance
risk
pre-de novo submission meeting
apotex
ranbaxy
genzyme
mensing
changes being effected
cbe
state substitution laws
rp
food
cdc
kefauver-harris amendments
1938
elixir sulfanilmide
the jungle
upton sinclair
pure food & drug act
virus toxin law
biologics control act
1902
harvey wiley
new drug application
cpg 130.300
aegerion
blinding
fpla
animal medicinal drug use clarification act
amduca
medicated feed
adufa
minor use/minor species
mums
investigational new animal drug
inad
201(v)
onade
office of new animal drug evaluation
major/minor uses
major/minor species
animal drug
priority review
pre-approval inspection
supplement
general/specific use
21 cfr 812.7
non-inferiority
conformity standard
significant risk device
device classification
201(h)
safe medical devices act
commissioner
center for devices & radiological health
cardiac lunch
cardiovascular device
technological characterization
device modification
pre-de novo submission
modifications
changes
office of device evaluation
ode
scp
standing committee on the law of patents
first to invent
european patent convention
epc
world trade organization
wto
world intellectual property organization
wipo
patent cooperation treaty
pct
nafta
trade-related aspects of intellectual property
trips
uruguay rounds
intellectual property
paris convention
treaty
mutual recognition agreement
mra
memorandum of understanding
iso
international standards organization
global harmonization task force
ghtf
congress
9001
13485
801
export
import
formularies
settlements
gratuity
dingell
desi
essential to approval
3-year exclusivity
nce
new chemical entity
reformulation
brand vs. generic
omnitrope
qbr
question based review
food effect
in vitro
in vivo
pharmaceutical equivalents
bioavailability
rtr
refuse-to-receive
crl
regulatory science
active pharmaceutical ingredient
api
pastor
prior approval supplement
dmf
generic drug user fee act
ftf
patent restoration
humanitarian device exemption
hde
deferral
pediatric assessment
pediatric rule
dan troy
andrew von eschenbach
lester crawford
food & drug administration amendments act of 2007
private right of action
failure to warn
impossibility preemption
implied conflict preemption
products liability
phenergan
demerol
preemption
fdli
perez v nidek
fraud
code of conduct
ethics
biologics licensing application
california institute for regenerative medicine
cirm
california stem cell research and cures act
proposition 71
stem cell
chemistry manufacturing and controls
sawp
scientific advice working party
scientific advice
small-to-medium size enterprise
sme
rtf
refuse to file
advisory committee
spa
eop
end of phase 2
toxicology
preclinical
lucentis
macugen
josh sharfstein
ophthalmic
medication guides
post-approval studies
abbey meyers
marlene haffner
rare disorder
rare disease
any given patient •
bpcia •
351(a) •
bla •
generic biologic •
fda •
risk evaluation and mitigation strategy •
interchangeability •
sepp •
seb •
subsequent entry protein product •
gain •
existing therapy •
clinically significant endpoints •
substantial improvement •
preliminary clinical evidence •
serious condition •
breakthrough therapy •
fast track •
phase 4 study •
fdasia •
surrogate marker •
intermediate clinical endpoint •
surrogate endpoint •
meaningful therapeutic benefit •
severely debilitating •
life threatening •
subpart e •
accelerated approval •
unmet medical need •
available therapy •
usan
any given patient
substituion
functional food
nutritional labeling
nlea
mineral
nutrition
ndi
security
raps
affairs
management
adulterated
nasdaq
nyse
21 cfr 806
field alert
recall classification
stock recovery
effectiveness checks
health hazard assessment
drugs
suspend
debar
civil litigation
charlie chang
parenttoolbox
mylan
duty to investigate
attorney fees
non-compliance
quality assurance program
embargo
u.s. attorney
doj
301
inspections
sponsor/investigator
drug eluting stent
biologic/drug
21 cfr 56
good clinical practices
drug information association
irbs
msa
master services agreement
contract research organiation
cro
cda
confidentiality
minimize
disqualification
21 cfr 312.70
slovenia
emea
eu clinical trial directive
eu
europe
e6
international
3674
who
acute myeloid leukemia
aml
gemtuzumab
mylotarg
central irb
coast irb
spitzer
india
indonésia
china
qualtiy
hipaa
investigation device exemption
law
liking
links
share widget
pharmawall
largo
misbrand
free speech
advamed code
general/specific
pre-clearance
wlf
washington legal foundation
scrutiny
speech
western states medical
false claims
ddmac
clinical trials
regulation
exempt
202.1
1571
substitution
gpha
biologics
outsourcing
207
513(f)(2)
ema
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