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SOCRA 2024 > CFR 21 Part 312 > Flashcards

CFR 21 Part 312 Flashcards

1
Q

21CFR PART 312

A

INVESTIGATIONAL NEW DRUG APPLICATION

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2
Q

The clinical investigation of a drug product that is lawfully marketed in the United States is exempt from
the requirements of this part if all the following apply:

A

i) The investigation is not intended to be reported to FDA in support of a new indication for use; no significant change in the labeling for the drug;
ii) If the drug is lawfully marketed as a prescription drug product & no significant change in the advertising for the product;
(iii) The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product;
(iv) The investigation is conducted in compliance with the requirements for institutional review set forth in part 56 (IRB) and with the requirements for informed consent set forth in part 50 (Protection of Human subjects);
(v) The investigation is conducted in compliance with the requirements of §312.7.

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3
Q

Clinical Investiagtions’ Exemptions from part 312

A

1) drug product that is lawfully marketed in the United States

2) in vitro diagnostic biological product (if it is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure)

3) A drug intended solely for tests in vitro or in laboratory research animals

4) use of a placebo is exempt from the requirements of this part if the investigation does not otherwise require submission of an IND.

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4
Q

A clinical investigation involving an in vitro diagnostic biological product is exempt from the requirements of this part if

A

(a) it is intended to be used in a diagnostic procedure that confirms the diagnosis made by another, medically established, diagnostic product or procedure

(b) it is shipped in compliance with §312.160.

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5
Q

The products exempt from the requirements of this part:

A

(a) blood grouping serum;
(b) reagent red blood cells;
(c) anti-human globulin.

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6
Q

A clinical investigation involving an exception from informed consent under §50.24 is exempt from the requirements of 312 part.

A

False

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7
Q

Clinical investigation

A

Any experiment in which a drug is administered or dispensed to, or used involving, one or more human subjects.

Imp: For the purposes of this part, an experiment is any use of a drug except for the use of a marketed drug in the course of medical practice.

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8
Q

Independent ethics committee (IEC)

A

A review panel that is responsible for ensuring the protection of the rights, safety, and well-being of human subjects involved in a clinical investigation and is adequately constituted to provide assurance of that protection (Example: An institutional review board (IRB)).

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9
Q

Investigational new drug means

A

A new drug or biological drug that is used in a clinical investigation. The term also includes a biological product that is used in vitro for diagnostic purposes.

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10
Q

Marketing application means

A

an application for a new drug submitted under section 505(b) of the act or a biologics license application for a biological product submitted under the Public Health Service Act.

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11
Q

Labeling of an investigational new drug

A

(a) shall bear a label with the statement “Caution: New Drug—Limited by Federal (or United States) law to investigational use.”
(b) shall not bear any statement that is false or misleading in any particular and shall not represent that the investigational new drug is safe or effective for the purposes for which it is being investigated.
(c) The appropriate FDA Center Director may grant an exception or alternative to the provision in paragraph (a) of this section, to the extent that this provision is not explicitly required by statute, for specified lots, batches, or other units of a human drug product that is or will be included in the Strategic National Stockpile.

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12
Q

A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that

A

an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise promote the drug.

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13
Q

A sponsor shall not unduly prolong an investigation after finding that the results of the investigation appear to establish sufficient data to support a marketing application.

A

True

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14
Q

The sponsor must obtain prior written authorization from FDA to charge for an investigational drug.

A

True

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15
Q

FDA will withdraw authorization to charge if

A

It determines that charging is interfering with the development of a drug for marketing approval or that the criteria for the authorization are no longer being met

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16
Q

A sponsor who wishes to charge for its investigational drug, including investigational use of its approved drug, must:

A

(i) Provide evidence that the drug has a potential clinical benefit
(ii) Demonstrate that the data to be obtained from the clinical trial would be essential to establishing that the drug is effective or safe for the purpose of obtaining initial approval of a drug, or would support a significant change in the labeling of an approved drug (e.g., new indication, inclusion of comparative safety information); and
(iii) Demonstrate that the clinical trial could not be conducted without charging because the cost of the drug is extraordinary to the sponsor.

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17
Q

Unless FDA specifies a shorter period, charging may continue for the length of the clinical trial.

A

True

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18
Q

(A sponsor who wishes to charge for expanded access to an investigational drug for treatment use, must provide

A

(i) Evidence of sufficient enrollment in any ongoing clinical trial(s) needed for marketing approval to assure FDA that the trial(s) will be successfully completed as planned;
(ii) Evidence of adequate progress in the development of the drug for marketing approval;
(iii) Information submitted under the general investigational plan specifying the drug development milestones the sponsor plans to meet in the next year.

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19
Q

The authorization to charge is limited

A

to the number of patients authorized to receive the drug under the treatment use, if there is a limitation.

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20
Q

Unless FDA specifies a shorter period, charging for expanded access to an investigational drug for treatment use is granted for

A

1 year. Sponsor may request re-authorization for additional periods.

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21
Q

A sponsor may recover only the….costs of making its investigational drug available.

A

direct

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22
Q

Direct costs include

A

costs per unit to manufacture the drug (e.g., raw materials, labor, and nonreusable supplies and equipment used to manufacture the quantity of drug needed for the use for which charging is authorized)
or
costs to acquire the drug from another manufacturing source, and direct costs to ship and handle (e.g., store) the drug.

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23
Q

Indirect costs include

A

-costs incurred primarily to produce the drug for commercial sale
-research and development,
-administrative, labor, or other costs that would be incurred even if the clinical trial or treatment use for which charging is authorized did not occur.

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24
Q

FDA may grant a waiver from this part if

A

it finds that the sponsor’s noncompliance would not pose a significant and unreasonable risk to human subjects and one of the following criteria is met:
(1) The sponsor’s compliance with the requirement is unnecessary for the agency to evaluate the application, or compliance cannot be achieved;
(2) The sponsor’s proposed alternative satisfies the requirement; or
(3) The applicant’s submission otherwise justifies a waiver.

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25
Q

FDA shall provide a written determination …..days after FDA receives the IND or earlier.

A

30

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26
Q

Phase 1 includes

A

a) typically closely monitored and may be conducted in patients or normal volunteer subjects.

2) determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness.

3) sufficient information about the drug’s pharmacokinetics and pharmacological effects should be obtained.

4) The total number of subjects is generally in the range of 20 to 80.

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27
Q

Phase 2

A

1) well-controlled studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study
2) to determine the common short-term side effects and risks associated with the drug.
3) well-controlled and closely monitored,
4) conducted in a relatively small number of patients, usually no more than several hundred subjects.

28
Q

Phase 3

A

Expanded controlled and uncontrolled trials.

Performed after preliminary evidence suggesting effectiveness of the drug has been obtained

Intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling.

Phase 3 studies usually include from several hundred to several thousand subjects.

29
Q

Phase I is sometimes referred to …………(where the rubber meets the road), since it is the first time that the drug is being tested in humans,

A

as the acid test of drug development

30
Q

……. may be considered as the real test since for the first time that the drug is tested in the real world.

A

Phase IV

31
Q

Phase IV

A

-Post-marketing
-Occurs after FDA approval
-Evaluates general use in population with side effect

32
Q

The investigator’s brochure should contain the following information:

A

(i) description of the drug substance and the formulation, including the structural formula, if known.

(ii) pharmacological and toxicological effects of the drug in animals and, to the extent known, in humans.

(iii) pharmacokinetics and biological disposition of the drug in animals and, if known, in humans.

(iv) safety and effectiveness information in humans obtained from prior clinical studies.

(v) possible risks and anticipated side effects ton the basis of prior experience with the drug under investigation or with related drugs,

vi) precautions or special monitoring to be done as part of the investigational use of the drug.

33
Q

Information amendments to the IND should be submitted as necessary but, to the extent feasible, not more than

A

30 days.

34
Q

Adverse event means

A

any untoward medical occurrence associated with the use of a drug in humans, whether or not
considered drug related.

35
Q

An adverse event or suspected adverse reaction is considered “life-threatening” if

A

In the view of either the investigator or sponsor, its occurrence places the patient or subject at immediate risk of death.

36
Q

An adverse event or suspected adverse reaction is considered “serious” if,

A

in the view of either the investigator or sponsor, it results in any of the following outcomes: Death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect.

37
Q

Suspected adverse reaction means

A

any adverse event for which there is a reasonable possibility that the drug caused the adverse event.

38
Q

Unexpected adverse event or unexpected suspected adverse reaction.

A

if it is not listed in the investigator brochure or

is not listed at the specificity or severity that has been observed;

Imp: also refers to adverse events or suspected adverse reactions that are mentioned in the investigator brochure as occurring with a class of drugs or as anticipated from the pharmacological properties of the drug, but are not specifically mentioned as occurring with the particular drug under investigation.

39
Q

The sponsor must notify FDA and all participating investigators in an IND safety report of potential serious risks, from clinical trials or any other source, as soon as possible, but in no case later than

A

15 calendar days

40
Q

A causal relationship between the drug and the adverse event is determined by

A

(A) A single occurrence of an event that is uncommon and known to be strongly associated with drug exposure

(B) One or more occurrences of an event that is not commonly associated with drug exposure, but is otherwise uncommon in the population exposed to the drug (e.g., tendon rupture)

(C) An aggregate analysis of specific events observed in a clinical trial that indicates those events occur more frequently in the drug treatment group than in a concurrent or historical control group.

41
Q

Submission of IND safety reports

A

15 calendar days
Unexpected fatal or life-threatening suspected adverse reaction reports: no later than 7 days

42
Q

Study endpoints (e.g., mortality or major morbidity) must be reported to FDA by the sponsor

A

as described in the protocol and ordinarily would not be reported

43
Q

If a serious and unexpected adverse event occurs for which there is evidence suggesting a causal relationship between the drug and the event, the event must be reported

A

as a serious and unexpected suspected adverse reaction even if it is a component of the study endpoint

44
Q

Adverse reactions reporting

A

Serious: 7 days
otherwise 15 days

45
Q

A sponsor shall submit a brief report of the progress of the investigation

A

Within 60 days of the anniversary date that the IND went into effect

46
Q

At any time a sponsor may withdraw an effective IND without prejudice.

A

True

47
Q

If an IND is withdrawn,

A

FDA and all current investigators shall be notified

All clinical investigations conducted under the IND shall be ended

All stocks of the drug returned to the sponsor or otherwise disposed of at the request of the sponsor

48
Q

If an IND is withdrawn because of a safety reason,

A

the sponsor shall promptly so inform FDA, all participating investigators, and all reviewing Institutional Review Boards, together with the reasons for such withdrawal.

49
Q

What is clinical hold

A

A clinical hold is an order issued by FDA to the sponsor to delay a proposed clinical investigation or to suspend an ongoing investigation.

50
Q

Form FDA 3500A vs. Form FDA 3500

A

3500A is used for mandatory reporting of medical device adverse events by manufacturers, user facilities and importers.

3500 is used for voluntary reporting of adverse events by healthcare professionals, consumers and patients.

51
Q

Division Director will provide the sponsor a written explanation of the basis for the clinical hold…

A

as soon as possible, and no more than 30 days after imposition of the clinical hold

52
Q

If a sponsor of an IND that has been placed on clinical hold requests in writing that the clinical hold be removed and submits a complete response to the issue(s) identified in the clinical hold order, FDA shall respond in writing to the sponsor within

A

30-calendar days of receipt of the request and the complete response.

53
Q

If all investigations covered by an IND remain on clinical hold for 1 year or more, the IND may be placed

A

On inactive status

54
Q

FDA can terminate the study if the IND has remained on inactive status for

A

5 years or more.

55
Q

If no subjects are entered into clinical studies for a period of 2 years or more under an IND, or if all investigations under an IND remain on clinical hold for 1 year or more, the IND may be placed by FDA

A

on inactive status

56
Q

The sponsor shall have …… to respond as to why the IND should continue to remain active.

A

30 days

57
Q

If the sponsor responds but FDA does not accept the explanation or correction submitted,

A

FDA shall inform the sponsor in writing of the reason for the nonacceptance and provide the sponsor with an opportunity for a regulatory hearing before FDA on the question of whether the IND should be terminated.

58
Q

The sponsor’s request for a regulatory hearing must be made within ….. of the sponsor’s receipt of FDA’s notification of nonacceptance.

A

10 days

59
Q

A sponsor who determines that its investigational drug presents an unreasonable and significant risk to subjects

A

shall discontinue those investigations that present the risk

notify FDA, all institutional review boards, and all investigators

assure the disposition of all stocks of the drug outstanding

furnish FDA with a full report of the sponsor’s actions.

60
Q

The sponsor shall discontinue the investigation that poses unneccessary, significant risk as soon as possible, and in no event later than

A

5 working days

61
Q

The sponsor shall retain the records and reports required

A

-for 2 years after a marketing application is approved for the drug

-if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.

62
Q

An investigator must report to the sponsor any serious adverse event, whether or not considered drug related, including those listed in the protocol or investigator brochure

A

Immediately

Investigator must include an assessment of whether there is a reasonable possibility that the drug caused the event.

63
Q

Study endpoints that are serious adverse events (e.g., all-cause mortality) must be reported .

A

in accordance with the protocol

64
Q

If there is evidence suggesting a causal relationship between the drug and the serious event that is also study end point (e.g., death from anaphylaxis).

A

the investigator must immediately report the event to the sponsor.

65
Q

The investigator must record nonserious adverse events and report them to the sponsor

A

According to the timetable for reporting specified in the protocol

SOCRA 2024 (9 decks)

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