Investigational Drugs & Devices: Difference between revisions
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'''<big> | '''Return to <big> [[Main Page]] </big>''' | ||
:::''curator: Paula Jacobs, PhD'' | |||
== '''Items Applicable to Investigational New Drugs (INDs)''' == | == '''Items Applicable to Investigational New Drugs (INDs)''' == | ||
21 CFR 312 (CFR = Code of Federal Regulations) | 21 CFR 312 (CFR = Code of Federal Regulations) | ||
IND is required for all investigational drugs (except for a few radiopharmaceuticals) | An Investigational New Drug Exemption (IND) is an exemption from the requirement that all drugs be approved by the Food and Drug Administration (FDA)before distribution. An IND is required for all investigational drugs (except for a few radiopharmaceuticals)for which: | ||
Drug is not marketed in US | :Drug is not marketed in US | ||
Drug is marketed in US, but this is a new indication or route of administration | :Drug is marketed in US, but this is a new indication or route of administration | ||
Drug is a modification of existing drug (even the solution) | :Drug is a modification of existing drug (even the solution or concentration) | ||
IND “Sponsor” can be: Company; Institution (e.g.,hospital, NCI); Individual (usually physician) | IND “Sponsor” can be: Company; Institution (e.g.,hospital, NCI); Individual (usually physician) | ||
| Line 17: | Line 17: | ||
Application must be made to the appropriate FDA Division (CDER, CBER…) | Application must be made to the appropriate FDA Division (CDER, CBER…) | ||
Specific | Specific information are needed for this application; | ||
#Pharmacology and toxicology information | #Pharmacology and toxicology information | ||
#Chemistry, manufacturing, and control | #Chemistry, manufacturing, and control | ||
#Dosimetry for radiopharmaceuticals | #Clinical trial information | ||
##Trial Protocol | |||
##Investigator qualifications | |||
#Dosimetry for radiopharmaceuticals | |||
#Previous human experience | |||
#Important reporting requirements | #Important reporting requirements | ||
##Serious adverse events | ##Serious adverse events | ||
##Annual report | ##Annual report | ||
Useful outlinks: | |||
Comprehensive FDA Guidance Page – http://www.fda.gov/cder/guidance/guidance.htm | :FDA Guidance on IND process with multiple links to other documentation http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm | ||
:Comprehensive FDA Guidance Page – http://www.fda.gov/cder/guidance/guidance.htm | |||
:A “how-to” guide from the Biological Development Program at NCI-Frederick with multiple links – http://wwwbdp.ncifcrf.gov/pdf/GuidetoRegSubs.pdf | |||
:FDA guidances on developing imaging drugs: | |||
::Part 1: Conducting Safety Assessments http://www.fda.gov/cder/guidance/5742prt1.pdf | |||
::Part 2: Clinical Indications http://www.fda.gov/cder/guidance/5742prt2.pdf | |||
::Part 3: Design, Analysis, and Interpretation of Clinical Studies http://www.fda.gov/cder/guidance/5742prt3.pdf | |||
'''Investigational Device Exemptions (IDEs)''' | '''Investigational Device Exemptions (IDEs)''' | ||
| Line 35: | Line 47: | ||
21 CFR 812 applies | 21 CFR 812 applies | ||
IDE is required for investigational devices that pose a significant risk | IDE is required for investigational devices that pose a significant risk when: | ||
Device is not marketed in US | :Device is not marketed in US | ||
Device is marketed in US, but this is a new indication or modification | :Device is marketed in US, but this is a new indication or modification | ||
“Significant risk” | “Significant risk” is determined by local IRB or by FDA | ||
IDE “Sponsor” is responsible which can be: Company, Institution (e.g., hospital, NCI), Individual | |||
Application must be made to the appropriate FDA Division (CDRH, etc) | Application must be made to the appropriate FDA Division (CDRH, etc) | ||
Important reporting requirements | |||
#Serious adverse events | |||
#Annual and semi-annual report | |||
Information resources: FDA Center for Devices and Radiological Health | Information resources: FDA Center for Devices and Radiological Health | ||
Latest revision as of 20:35, 29 December 2007
Return to Main Page
- curator: Paula Jacobs, PhD
Items Applicable to Investigational New Drugs (INDs)
21 CFR 312 (CFR = Code of Federal Regulations)
An Investigational New Drug Exemption (IND) is an exemption from the requirement that all drugs be approved by the Food and Drug Administration (FDA)before distribution. An IND is required for all investigational drugs (except for a few radiopharmaceuticals)for which:
- Drug is not marketed in US
- Drug is marketed in US, but this is a new indication or route of administration
- Drug is a modification of existing drug (even the solution or concentration)
IND “Sponsor” can be: Company; Institution (e.g.,hospital, NCI); Individual (usually physician)
Application must be made to the appropriate FDA Division (CDER, CBER…)
Specific information are needed for this application;
- Pharmacology and toxicology information
- Chemistry, manufacturing, and control
- Clinical trial information
- Trial Protocol
- Investigator qualifications
- Dosimetry for radiopharmaceuticals
- Previous human experience
- Important reporting requirements
- Serious adverse events
- Annual report
Useful outlinks:
- FDA Guidance on IND process with multiple links to other documentation http://www.fda.gov/cder/regulatory/applications/ind_page_1.htm
- Comprehensive FDA Guidance Page – http://www.fda.gov/cder/guidance/guidance.htm
- A “how-to” guide from the Biological Development Program at NCI-Frederick with multiple links – http://wwwbdp.ncifcrf.gov/pdf/GuidetoRegSubs.pdf
- FDA guidances on developing imaging drugs:
- Part 1: Conducting Safety Assessments http://www.fda.gov/cder/guidance/5742prt1.pdf
- Part 2: Clinical Indications http://www.fda.gov/cder/guidance/5742prt2.pdf
- Part 3: Design, Analysis, and Interpretation of Clinical Studies http://www.fda.gov/cder/guidance/5742prt3.pdf
Investigational Device Exemptions (IDEs)
21 CFR 812 applies
IDE is required for investigational devices that pose a significant risk when:
- Device is not marketed in US
- Device is marketed in US, but this is a new indication or modification
“Significant risk” is determined by local IRB or by FDA
IDE “Sponsor” is responsible which can be: Company, Institution (e.g., hospital, NCI), Individual
Application must be made to the appropriate FDA Division (CDRH, etc) Important reporting requirements
- Serious adverse events
- Annual and semi-annual report
Information resources: FDA Center for Devices and Radiological Health http://www.fda.gov/cdrh/index.html
Device Advice: http://www.fda.gov/cdrh/devadvice/