US RAC Exam Prep
30-day hold -
☑️ (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA
approval to proceed with enrollment. Also, the time period between when a company submits an IND
and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the
proposed protocol. (see "Clinical Hold.")
120-day Safety Report -
☑️ Amendment to an NDA containing a safety update due 120 days after the NDA is filed.
180-day Exclusivity -
☑️ Protects an ANDA applicant from competition from subsequent generic versions of the same
drug for 180 days.
505(b)(2) Application -
☑️ An application submitted under section 505(b)(2) of the FD&C Act for a drug for which one
or more of the investigations relied on by the applicant for approval of the "application were not
conducted by or for the applicant and for which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were conducted" (21 U.S.C. 355(b)(2)).
Traditional 510(k) -
☑️ A premarket notification (PMN) submitted to FDA to demonstrate that the medical device to
be marketed is safe and effective or "substantially equivalent" to a legally marketed device. 510(k)
refers to the section of the FD&C Act authorizing the submission of the premarket notification. FDA
processing time is 90 days.
Special 510(k) -
☑️ For use where device modifications neither affect the intended use nor alter its fundamental
scientific technology. FDA processing time is 30 days.
Abbreviated 510(k) -
☑️ A type of 510(k) submission that is supported by conformance with guidance document(s),
special controls or standards. FDA processing time is 90 days.
515 Program Initiative -
☑️ Created to facilitate reclassification action on the remaining pre-amendments Class III
510(k)s.
Accelerated Approval -
☑️ Allows earlier approval of drugs to treat serious diseases and those that fill an unmet medical
need based on a surrogate endpoint.
Action Letter -
, ☑️ Official communication from FDA informing an NDA or BLA sponsor of an agency
decision; includes approvable, not approvable and clinical hold.
ADME -
☑️ Absorption, Distribution, Metabolism and Excretion
Adulterated -
☑️ Product containing any filthy, putrid or decomposed substance; or prepared under unsanitary
conditions; or not made according to GMPs; or containing an unsafe color additive; or does not meet
the requirements of an official compendium (FD&C Act, SEC. 501 [351])
Advisory Committee -
☑️ Committees and panels used by FDA to obtain independent expert advice on scientific,
technical and policy matters.
ANDA -
☑️ Abbreviated New Drug Application. Used for generic drugs. Found in 21 CFR 314.92 and
505(j) of the FD&C Act. Are not required to include animal safety and clinical data to demonstrate
safety and efficacy, but for oral dosages forms must scientifically demonstrate that the drug is
bioequivalent to the Reference Listed Drug (RLD). CMC (Chemistry, Manufacturing and Controls) is
required.
Annual Report -
☑️ An annual periodic report or progress report that must be submitted to FDA. Depending on
the type of application for which the report is submitted, it may include new safety, efficacy and
labeling information; preclinical and clinical investigation summaries; CMC updates; nonclinical
laboratory studies; and completed unpublished clinical trials
Approved -
☑️ FDA designation given to drugs, biologics and medical devices that have been granted
marketing approval
Banned Device -
☑️ Device presenting a substantial deception, unreasonable risk or injury or illness, or
unreasonable direct substantial danger to public health.
BIMO -
☑️ Bioresearch Monitoring Program
Bioequivalence -
☑️ The absence of a significant difference in the rate and extent to which the active ingredient
or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at
the site of drug action when administered at the same molar dose under similar conditions in an
appropriately designed study.
Biologic -
, ☑️ A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative,
allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or
arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound)
applicable to the prevention, treatment or cure of disease or condition of human beings.
Biosimilar -
☑️ Under the BPCI Act (Biologics Price Competition and Innovation Act of 2009), a biological
product may be demonstrated to be "biosimilar" if data show that, among other things, the product is
"highly similar" to an already approved biological product.
BLA -
☑️ Biologics License Application
CBE-30 -
☑️ Changes Being Effected in 30 days. A submission to an approved application reporting
changes the FDA has identified as having moderate potential to adversely affect drug product identity,
strength, quality, purity and potency. The supplement must be received by FDA at least 30 days before
product distribution.
CBER -
☑️ Center for Biologics Evaluation and Research
CDER -
☑️ Center for Drug Evaluation and Research
CDRH -
☑️ Center for Devices and Radiological Health
Consent Form (CF or ICF) -
☑️ Document used to inform a potential subject of the risks and benefits of a clinical trial per
the Declaration of Helsinki.
Certificate to Foreign Government (CFG) -
☑️ Required by certain countries to prove that an exported product can be legally marketed in
the US.
CFR -
☑️ Code of Federal Regulations
Class I Device -
☑️ Low-risk device requiring general controls to ensure safety and effectiveness.
Class II Device -
☑️ Requires general and special controls to ensure safety and effectiveness. Special controls
may include mandatory performance standards, patient registries for implantable devices and
postmarket surveillance. Requires 510(k), unless exempted; may require clinical trials.
30-day hold -
☑️ (aka 30-day safety review) Time frame between filing a protocol under an IND and the FDA
approval to proceed with enrollment. Also, the time period between when a company submits an IND
and when it can initiate a protocol. This timeline may be extended if FDA does not agree with the
proposed protocol. (see "Clinical Hold.")
120-day Safety Report -
☑️ Amendment to an NDA containing a safety update due 120 days after the NDA is filed.
180-day Exclusivity -
☑️ Protects an ANDA applicant from competition from subsequent generic versions of the same
drug for 180 days.
505(b)(2) Application -
☑️ An application submitted under section 505(b)(2) of the FD&C Act for a drug for which one
or more of the investigations relied on by the applicant for approval of the "application were not
conducted by or for the applicant and for which the applicant has not obtained a right of reference or
use from the person by or for whom the investigations were conducted" (21 U.S.C. 355(b)(2)).
Traditional 510(k) -
☑️ A premarket notification (PMN) submitted to FDA to demonstrate that the medical device to
be marketed is safe and effective or "substantially equivalent" to a legally marketed device. 510(k)
refers to the section of the FD&C Act authorizing the submission of the premarket notification. FDA
processing time is 90 days.
Special 510(k) -
☑️ For use where device modifications neither affect the intended use nor alter its fundamental
scientific technology. FDA processing time is 30 days.
Abbreviated 510(k) -
☑️ A type of 510(k) submission that is supported by conformance with guidance document(s),
special controls or standards. FDA processing time is 90 days.
515 Program Initiative -
☑️ Created to facilitate reclassification action on the remaining pre-amendments Class III
510(k)s.
Accelerated Approval -
☑️ Allows earlier approval of drugs to treat serious diseases and those that fill an unmet medical
need based on a surrogate endpoint.
Action Letter -
, ☑️ Official communication from FDA informing an NDA or BLA sponsor of an agency
decision; includes approvable, not approvable and clinical hold.
ADME -
☑️ Absorption, Distribution, Metabolism and Excretion
Adulterated -
☑️ Product containing any filthy, putrid or decomposed substance; or prepared under unsanitary
conditions; or not made according to GMPs; or containing an unsafe color additive; or does not meet
the requirements of an official compendium (FD&C Act, SEC. 501 [351])
Advisory Committee -
☑️ Committees and panels used by FDA to obtain independent expert advice on scientific,
technical and policy matters.
ANDA -
☑️ Abbreviated New Drug Application. Used for generic drugs. Found in 21 CFR 314.92 and
505(j) of the FD&C Act. Are not required to include animal safety and clinical data to demonstrate
safety and efficacy, but for oral dosages forms must scientifically demonstrate that the drug is
bioequivalent to the Reference Listed Drug (RLD). CMC (Chemistry, Manufacturing and Controls) is
required.
Annual Report -
☑️ An annual periodic report or progress report that must be submitted to FDA. Depending on
the type of application for which the report is submitted, it may include new safety, efficacy and
labeling information; preclinical and clinical investigation summaries; CMC updates; nonclinical
laboratory studies; and completed unpublished clinical trials
Approved -
☑️ FDA designation given to drugs, biologics and medical devices that have been granted
marketing approval
Banned Device -
☑️ Device presenting a substantial deception, unreasonable risk or injury or illness, or
unreasonable direct substantial danger to public health.
BIMO -
☑️ Bioresearch Monitoring Program
Bioequivalence -
☑️ The absence of a significant difference in the rate and extent to which the active ingredient
or active moiety in pharmaceutical equivalents or pharmaceutical alternatives becomes available at
the site of drug action when administered at the same molar dose under similar conditions in an
appropriately designed study.
Biologic -
, ☑️ A virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative,
allergenic product, protein (except any chemically synthesized polypeptide), or analogous product, or
arsphenamine or derivative of arsphenamine (or any other trivalent organic arsenic compound)
applicable to the prevention, treatment or cure of disease or condition of human beings.
Biosimilar -
☑️ Under the BPCI Act (Biologics Price Competition and Innovation Act of 2009), a biological
product may be demonstrated to be "biosimilar" if data show that, among other things, the product is
"highly similar" to an already approved biological product.
BLA -
☑️ Biologics License Application
CBE-30 -
☑️ Changes Being Effected in 30 days. A submission to an approved application reporting
changes the FDA has identified as having moderate potential to adversely affect drug product identity,
strength, quality, purity and potency. The supplement must be received by FDA at least 30 days before
product distribution.
CBER -
☑️ Center for Biologics Evaluation and Research
CDER -
☑️ Center for Drug Evaluation and Research
CDRH -
☑️ Center for Devices and Radiological Health
Consent Form (CF or ICF) -
☑️ Document used to inform a potential subject of the risks and benefits of a clinical trial per
the Declaration of Helsinki.
Certificate to Foreign Government (CFG) -
☑️ Required by certain countries to prove that an exported product can be legally marketed in
the US.
CFR -
☑️ Code of Federal Regulations
Class I Device -
☑️ Low-risk device requiring general controls to ensure safety and effectiveness.
Class II Device -
☑️ Requires general and special controls to ensure safety and effectiveness. Special controls
may include mandatory performance standards, patient registries for implantable devices and
postmarket surveillance. Requires 510(k), unless exempted; may require clinical trials.
