Vocabulary (1-100) Flashcards
Amendment to a NDA containing a safety update due 120 days after the NDA is filed.
120-day Safety Report
Time period between filing a protocol under an IND and 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 time line may be extended if FDA does not agree with the proposed protocol.
30-day hold **
A form of NDA that incorporates data without a right of reference and can rely on published literature, previously approved NDA, of “Bridging Studies” or the combination of all three. Cannot file if eligible for an ANDA. Used for new salts, dosage forms, routes of administration, etc.
505(b)(2)
i. Traditional 510(k): A premarket notification submitted to FDA to demonstrate that the medical device to be marketed is as safe and effective or “substantially equivalent” to a legally marketed device. 510(k) refers to the section of the Federal Food, Drug and Cosmetic Act authorizing the submission of the premarket notification.
ii. Special 510(k): For use where device modifications neither affect the intended use nor alter its fundamental scientific technology. Processing time is 30 days.
iii. Abbreviated 510(k): Submission based upon guidance document(s), special controls or standards.
510(k)
AAAS
American Association for the Advancement of Science
AABB
American Association of Blood Banks
Primarily used for generics on the 505(j) Form.
Abbreviated Antibiotic Drug Application: AADA
AAPS
American Association of Pharmaceutical Scientists
ACS
American Chemical Society
Any unexpected, unfavorable event that is may or may not be related to the use of the investigational drug.
Adverse Clinical Event: ACE
Official communication from FDA informing NDA/BLA sponsor of an agency decision. Includes approvable, not approvable, clinical hold, and warning letters.
Action Letter**
Any drug component intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment or prevention of disease, or to affect the structure or any function of the body of man or other animals.
Active Ingredient
ADE
Adverse Drug Event or Adverse Drug Experience
ADME of chemicals and investigational drugs is essential in measuring Pharmacokinetics.
Absorption, Distribution, Metabolism and Excretion: ADME
Any unexpected adverse drug experience not listed in the drug product’s current labeling
Adverse Drug Reaction: ADR
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.
Adulterated
Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment; an investigator shall promptly report to the sponsor any adverse effect that may reasonably regarded as caused by, or probably cause by the drug.
Adversent Event: AE
A database that contains information on adverse event and medication error reports submitted to FDA.
Adverse Event Reporting System: AERS
AFDO
Association of Food and Drug Officials
AHCPR
Association for Health Care Policy and Research
FDA’s approach to reviewing applications that may be affected by wrongful acts that raise significant questions regarding data reliability.
Application Integrity Policy: AIP
Additions or changes to an ANDA, NDA, PMA or PMA supplement still under review. Includes safety updates. Any updates to an IND are also called amendments.
Amendment
Used for generic animal drugs. Must reference a “listed drug”. Contains copies of literature and bioequivalence studies comparing the generic drug to the innovator drug as evidence of safety and efficacy.
Abbreviated New Animal Drug Application: ANADA
Used for generic drugs. Must reference a “listed drug”. Contains copies of literature and bioequivalence studies comparing the generic drug to the innovator drug as evidence of safety and efficacy.
- Generic vs. Listed Drug must be same:
1. onditions of use
2. ctive Ingredient
3. oute of Administration, Dosage form, and Strength
4. Labeling
Abbreviated New Drug Application: ANDA
The sections that the ANDA must include are:
- Regulatory and Administrative Requirements (I.E Paragraph Certification, Reference Listed Drug (monograph), Exclusivity Addressed, Rx to OTC status if necessary.)
- Chemistry
- Manufacturing
- Controls
- Labeling
- Testing
- Bioequivalence
ANDA Sections
An annual periodic report or progress report that must be submitted to the FDA. It must include new safety, efficacy, and labeling information; preclinical and clinical investigation summaries; CMC updates; nonclinical laboratory studies; and completed unpublished clinical trials.
Annual Report
APHIS
Animal and Plant Health Inspection Service
Any substance or mixture of substances intended to be used in the manufacture of a medicinal product that, when used in the production of a drug, becomes an active ingredient of the medicinal product.
Active Pharmaceutical Ingredient: API**
FDA designation given to drugs, biologics and medical devices that have been granted marketing approval.
Approved
A quality standard that allows for a pre-specified number of defects. It is either a calculated or historical value that is used to determine acceptance limits for either produced or purchased goods.
Acceptable Quality Level: AQL**
ASQ
American Society for Quality (formerly ASQC)
ASR
Analyte Specific Reagents
BACPAC
Bulk Actives Chemical Post Approval Changes
Device presenting a substantial deception, unreasonable risk of injury or illness, or unreasonable direct and substantial danger to public health
Banned Devices**
BATF
Bureau of Alcohol, Tobacco, and Firearms
BIMO
Bioresearch Monitoring Program
BIO
BIO Biotechnology Industry Organization
The quality control team must inspect all documents and data to ensure that the product may be distributed before it can be released from the manufacturing plant. All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
Batch Release Requirements (Drugs)
Any virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood componenet or derivative, allergenic product, protein, or analogous product applicable to the prevention, treatment, or cure of a disease or condition of human beings.
Biologic
