| CONDUCTED AFTER A DRUG OR DEVICE HAS BEEN APPROVED FOR CONSUMER SALE.
result in a drug or device being TAKEN OFF THE MARKET or restrictions of use could be placed on the product depending on the findings in the study. | Post Marketing Surveillance Trials |
| Pharmaceutical companies
objectives: | 1 to COMPARE A DRUG WITH OTHER DRUGS already IN THE MARKET;
2 to MONITOR A DRUG'S LONG-TERM EFFECTIVENESS and impact on a patient's quality of life; and
3 to DETERMINE THE COST-EFFECTIVENESS of a
drug
therapy relative to other traditional and new
therapies. |
| Phase IV Clinical Trial: ETHICAL PROBLEMS | 1 TAKING PATIENTS OFF STANDARD THERAPY to TRY THE NEW DRUG.
2 The INVESTIGATOR must not only promise but MUST DELIVER APPROPRIATE CARE to ANYONE who SUFFERS ADVERSE REACTIONS. |
| Responsibilities of Sponsors and Investigators | 1 SELECTING QUALIFIED INVESTIGATORS
2 PROVIDING THEM WITH THE INFORMATION they need to conduct an investigation properly
3 ENSURING PROPER MONITORING of investigation,
4 ensuring that the investigation is conducted in ACCORDANCE WITH THE GENERAL INVESTIGATIONAL PLAN and protocols contained in the IND
5 ensuring that FDA and all participating INVESTIGATORS are promptly INFORMED OF SIGNIFICANT NEW ADVERSE EFFECTS OR RISKS |
| Responsibilities of Sponsors and Investigators: Others | 1 selecting investigators and monitors
2 informing investigators
3 review of ongoing investigations
4 recordkeeping and record retention
5 inspection of sponsors records and reports
6 disposition of unused supply of investigational drug |
| 1 Responsibilities of Investigators
2 Responsibilities of Investigators: Others | 1 responsible for administering the investigational drug to the study subject as well for its welfare.
2 ensures that the investigation is conducted according to plan, for protecting rights, safety and welfare of the subjects
2)
1 control and handling of investigational drug
2 investigator record keeping and retention
3 investigator reports
4 assurance of I R B review |
| Preparing NDA | A document which is submitted by sponsors requesting FDA approval to market a new drug for human use.
contains that data to show that the drug is safe and efficacious for the intended population
prepared to support the statements in the proposed package insert.
Its purpose is to demonstrate that a drug is safe and effective for its intended use in the population studied.
A drug developer must include everything about a drug—from preclinical data to Phase 3 trial data
include reports on all studies, data, and analyses.
- Proposed labeling Safety updates
- Drug abuse information Patent information
- Any data from studies that may have been conducted outside the United States
- Institutional - review board compliance information
- Directions for use |
| NDA Team | 1 Biopharmaceutics
2 Drug experience
3 manufacturing
4 control
5 path/tox
6 project mgt.,
7 clinical unit,
8 medical writers
9 statistics,
10 pharmacology
11 medical events
12 regulatory |
| FDA REVIEW
Once the FDA receives an NDA,
the review team decides if it is
complete.
the review team has __ months
to make a decision on whether to
approve the drug. | 6 to 10 MONTHS |
| FDA REVIEW PROCESS | 1 Each member of the review team CONDUCTS A FULL REVIEW of his or her section of the application.
2 FDA inspectors travel to CLINICAL STUDY SITES to conduct a ROUTINE INSPECTION. The Agency looks for evidence of fabrication, manipulation, or withholding of data.
3 The PROJECT MANAGER ASSEMBLES ALL INDIVIDUAL REVIEWS AND OTHER DOCUMENTS, such as the inspection report, into an “ACTION PACKAGE” This document becomes the record for FDA review. The review team issues a recommendation, and a senior FDA official makes a decision. |
| This document becomes the record for FDA review. The review team issues a recommendation, and a senior FDA official makes a decision. | action package |
| FDA Approval
1 necessary to work with the applicant to develop and refine prescribing information. This is referred to as __
accurately and objectively describes the basis for approval and how best to use the drug. | “labeling.” |
| FDA may organize a meeting of one of its __ to get independent, expert advice and to permit the public to make comments.
may include a Patient Representative that provides input from the patient perspective. | FDA Advisory Committees |
| Drug approval
1 Approved:
2 NOT Approved:
3 Approvable: | 1 the sponsor may now market the product
2 the product may not be marketed, provides detailed explanation of the reasons for the decision
3 FDA is prepared to approve the NDA after the sponsor rectifies identified deficiencies and satisfies condition in the complete response letter. |
