30-day hold - ANSWER-(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 - ANSWER-Amendment to an NDA containing a safety
update due 120 days after the NDA is filed.
180-day Exclusivity - ANSWER-Protects an ANDA applicant from competition
from subsequent generic versions of the same drug for 180 days.
505(b)(2) Application - ANSWER-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) - ANSWER-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) - ANSWER-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) - ANSWER-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.
Approved - ANSWER-FDA designation given to drugs, biologics and medical
devices that have been granted marketing approval
,Banned Device - ANSWER-Device presenting a substantial deception,
unreasonable risk or injury or illness, or unreasonable direct substantial
danger to public health.
BIMO - ANSWER-Bioresearch Monitoring Program
515 Program Initiative - ANSWER-Created to facilitate reclassification action
on the remaining pre-amendments Class III 510(k)s.
Accelerated Approval - ANSWER-Allows earlier approval of drugs to treat
serious diseases and those that fill an unmet medical need based on a
surrogate endpoint.
Action Letter - ANSWER-Official communication from FDA informing an NDA
or BLA sponsor of an agency decision; includes approvable, not approvable
and clinical hold.
ADME - ANSWER-Absorption, Distribution, Metabolism and Excretion
Adulterated - ANSWER-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 - ANSWER-Committees and panels used by FDA to
obtain independent expert advice on scientific, technical and policy matters.
ANDA - ANSWER-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 - ANSWER-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
Bioequivalence - ANSWER-The absence of a significant difference in the rate
and extent to which the active ingredient or active moiety in pharmaceutical
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