Safety First
The city where the declaration to enshrine subject safety was signed in June of 1964.
Where is Helsinki, Finland?
The Form issued by FDA to list objectionable practices.
What is a Form 483?
The acronym for the set of current regulations governing the manufacture, labeling, packaging and distribution of approved drug products.
What is cGMP?
A clinical assay developed and used at a single facility.
What is a Laboratory Developed Test (LDTs)?
The boy band who had a hit single "I want it That Way" with the refrain "Tell me Why".
Who are the Backstreet Boys?
The report published in 1979 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to ensure subject safety in the U.S.
What is the Belmont Report?
This correspondence notifies an establishment that they were found in major or repeated nonconformance to the FDA regulations.
What is a Warning Letter?
Regulations enacted following submission of fraudulent nonclinical study reports to FDA and EPA.
What are the GLPs?
The current international guidance on how to validate bioanalytical methods.
What is ICH M10?
The adulteration of foods and drugs sold in the US resulted in this federal Act.
What is the Food and Drugs Act of 1906.?
HHS regulation that specifically protects children as research subjects.
What is 45 CFR Part 46 Subpart D?
FDA action that permits the exclusion of completed studies conducted by a testing facility or clinical investigator who were found to have violated applicable regulations.
What is Disqualification?
The acronym for the set of guidance documents and regulations governing the conduct of clinical trials.
What are the GCPs?
The organization that set up the first US standard for clinical sample testing.
What is College of American Pathologists (CAP)?
Nickname for the vivarium room at IBTL that resulted in animal care requirements for nonclinical studies.
What is the "Swamp".
The person(s) who can sign the informed consent form for pediatric subjects.
Who are the Parents or Guardians?
The FDA list that includes persons or companies that engaged in criminal conduct with respect to the development or approval of new drugs.
What is Debarment List?
The FDA regulation governing electronic records and signatures to support other predicate rules.
What is 21 CFR Part 11?
The semi-annual program to assess the continued performance and reproducibility of clinical tests.
What is Proficiency Testing?
The repeat analyses of nonclinical and clinical samples to assess reproducibility of the bioanalytical method.
What is Incurred Sample Reanalysis (ISR)?
Per 21 CFR Part 50.23 (d)(1), the person who can waive the prior consent requirement for the administration of an investigational new drug to a member of the armed forces in connection with the member's participation in a particular military operation.
Who is the President?
A legal agreement between FDA and a pharmaceutical company or facility, which outlines specific actions that the company must take to address the violations and comply with regulatory standards.
What is a Consent Decree?
The International Guidance on how to conduct clinical trials.
What is ICH E6(R2)?
The training program at certified laboratories to periodically assess a technicians ability to perform an assay.
What is Competency Assessment?
Pharmacovigilence was brought to the forefront in Europe in 1961 following congenital malformations linked to this antinausea drug.
What is Thalidamide?