Emergency INDs

Emergency INDs (often supplements to or amendments of standard INDs) receive priority review and accelerated consideration. As supplements, emergency INDs are generally abbreviated formats referencing the original IND (with a newly filed 1571 form). Most often, they represent corrections or modifications in the experimental design, chemistry, and/or control of the new drug. 

The Guidance for Institutional Review Boards and Clinical Investigators contains information on Obtaining an Emergency IND, Emergency Exemption from Prospective IRB, Approval Exception from Informed Consent, and Requirement Planned Emergency Research, Informed Consent Exception. 

If an emergency IND number was previously assigned by the FDA, or the Form FDA 1571 is being included with an amendment to the original IND, then that IND number should be entered here otherwise, the space should be left blank. 

It should be noted that off-label use of approved products (i.e. prescribing lawfully marketed products for indications other than those stated in their labeling) does not require an Emergency IND, under 21 CFR paras 312.2(b)(i)-(v), provided that the intended use... 

The Emergency IND (21CFR para 312.36) is designed to permit a physician to treat a particular... 

The third and very valuable discovery that the new phthalazine (PHAL) and pyrimidine (PYR) ligand classes (32-35, Figure 2) out-perform the monomeric ligands under identical conditions emerged from a heuristic screening process. The PHAL class in particular has become the first choice for most olefin classes. The PYR class is usually superior for terminal olefins, while the IND class is ideally suited for cA-disubstituted olefins. These ligands are commercially available or can be made easily from relatively inexpensive starting materials. 

Grossel, S. S., "An Overview of Equipment for Containment and Disposal of Emergency Relief System Effluents," J. Loss Prev. Proc. Ind., 3, No. 1,112 (January 1990). 

Three t)rpes of rmusual IND situations deserve special mention. First, the regulations contain a provision governing emergency use of an investigational new drug. Where FDA will permit such use by telephone or other rapid communication means. In these situations, the IND must subsequently be amended to reflect the new situation. Second, FDA will approve specific... 

The productivity of research and development efforts within the pharma industry has declined significantly in the past decade. While large numbers of INDs are submitted each year, only a small proportion in the pipeline emerges as NDA submissions or approvals. NDA submissions have fallen by half, from a high of 50 in 1995,... 

Anon Emergency exposure limits Nitrogen dioxide. Am Ind Hyg Assoc J 25 580-582, 1964... 

Currently, most INDs are submitted in paper form, often accompanied by an electronic disk with hyperlinks. Purely electronic submissions are still rare, in large part because of a lack of standardization and electronic sophistication on the part of the FDA. There is currently a Clinical Data Interchange Standards Consortium (CDISC) test underway assuming it proves successful, it is likely that CD ISC will emerge as a common electronic submission standard for INDs, New Drug Applications (NDAs), and Abbreviated New Drug Applications (ANDAs) over the next three to five years. 

Emergency Use IND allows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR, Sec. 312.23 or Sec. 312.34. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist. 

INDs Exception from Informed Consent Requirements for Emergency Research. (Issued February 4,2003)... 

The extensive IND literature review, evaluating all relevant international publications concerning the drug, should be carefully updated and reanalyzed for trends and emerging problems. This requires more than just an addition to the first IND literature review to reflect the years that have passed the reanalysis of the composite body of literature may reveal hidden problems that should be addressed. 

Huff, J. E, A General Approach to the Sizing of Emergency Pressure Relief Systems, Reprints of Int. Symp. on Loss Prev. and Safety Promotion in the Process Ind., Heidelberg, Germany, 1977, p. IV 223, DECHEMA, Frankfurt (1977). 

When a human subject does not meet the criteria stipulated in an existing study protocol or if an approved study protocol is not available, the manufacturer of the test article should be contacted to determine if the company will make the test article available for emergency use under the manufacturer s IND. If an emergency occurs before an IND submission and the manufacturer agrees to make the test article available, the FDA would have to authorize shipment. 

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