Products exempt from IND application include:
1.Lawfully marketed drugs
2. Drugs not intended to be reported to the fda for new indications or labeling
3. Investigation does not involve route/administration changes
4. In vitro diagnostic biological products
5. Drugs to be used for lab animals.
Requirements for labeling IND drugs
Investigational drugs must bear the statement “caution: new drug limited by federal law to investigational use”
Label shall not bear fall statements regarding safety or Efficacy
No nos for INDs:
Drugs may not be promoted as safe or effective
Drugs may not be commercially distributed or test marketed
Charging for Investigational drugs some requirements
- Amount charge must be justified.
- Fda authorization for charging required
- Sponsor can demonstrate cost of drug high for sponsor.
- Can charge for expanded access use.
- Expanded access use cannot interfere with ongoing study
Recoverable costs when charging for an investigational drug
- Only direct costs of making drug may be covered
- Cost incurred specifically and exclusively for providing drugs.
- Indirect costs for research and development, labor, admin ect. That would have occurred without the active clinical trial are not recoverable.
- Sponsor must provide supporting documentation of calculations for cost recovery
Ind content and format
- Cover sheet
- Table of contents
- Into statement w/ general CI plan
- Investigators brochure
- Protocols
- Chem, manufacturing, & control info
- Pharmacology and toxicology info
- Descriptions of previous investigations
- Any additional information
- Any other relevant info requested by FDA.
Ind cover sheet must include:
- Sponsor name, contact info, and drug name
- Identify phase or phases of
- Commitments- wait for IND, irb approval, and to abide by regs and reqs.
- Name contact info for party monitoring.
- Name and title of person s for information relevant to drug safety.
- Info of any CRO participating.
- Signature of sponsor or sponsors authorized rep
IND APPLICATION table of contents
- Drug name, active ingredients, pharmaco class, structural formula, dosage forms, route of admin, objectives, proposed CI.
- Brief summary of previous human experience.
- Any CI withdrawals due to safety or efficacy.
- Investigational plan for following year. Including rationale for drug and indication to be studied.
- General approach and plan for evaluating drug.
IND investigators brochure to include:
- Drug substance and structural formula.
- Summary of all pharmaco and toxicology in humans and animals
- PK and bio disposition of drug in animals and humans.
- Side effects and risks based on prior studies.
- Safety and efficacy from prior studies
- Protocols for each planned study: including purpose objectives, inclusion/ exclusion criteria, design with enrollment goals
Additional info that maybe required for ind application
- Drug dependency and abuse potential
- Radioactive drugs- calculate radiation absorbed through while body and critical organs
- Peds- additional plans for safety and efficacy.
IND protocol amendments
1.Changes to protocol that effect sub safety, scope of study, or scientific quality must be submitted.
2. Changes to dosage or exposure or increased number of planned enrollment.
3. Significant design changes
4. Changes to planned tests or procedures to improve monitoring or decrease risk.
5. Changes to eliminate immediate hazard may happen immediately, subsequently notify FDA and IRB.
6. new investigators reported to fda within 30 days.
7. Submission must be labeled “Protocol amendment: New protocol, Change in protocol, ect. As appropriate
8. Can reference info from previous submissions. (ID name, reference #, volume and page number)
Ind informational amendments
Used to report essential info on drug that is outside the scope of approved protocol. Such as: New toxicology info, a discontinuation of a clinical investigation.
* Must be clearly labeled as “Informational amendment”
