I got into this debate the other day at work. If the Sponsor delivers the IB to the CRO who then delivers them to the sites. Who is responsible for the content of the IB? Does this account for a transfer of responsibility? I personally don't think so.

This documented transfer is often times referred to as a TORO (Transfer of Regulatory Obligations) and the only items that can be transferred to a CRO are further outlined in 21 CFR 312.52.

I like it that this document includes both Audit/Inspection as they can often times be confused. Regulatory agencies only conduct Inspections.

I've also heard of this referred to as an "Expected Adverse Event." Has anyone else heard this term before?

• Module 1 contains region-specific information; for the US this is Form 356h, prescribing information and risk evaluation and mitigation strategy)
• Module 2 ICH Quality Overall Summary (QOS), which consists of a summary and overview of the following three modules
• Module 3 contains ICH M4Q(R1), which consists of quality information
• Module 4 contains ICH M4S(R2), which consists of safety information
• Module 5 contains ICH M4E(R1), which consists of efficacy information

The Application Form refers to the application described under §314.50, which would be the NDA.

The applicant is "the person who submits an application or abbreviated application or an amendment or supplement to them under this part to obtain FDA approval of a new drug or an antibiotic drug and any person who owns an approved application or abbreviated application."

https://via.hypothes.is/http://www.ecfr.gov/cgi-bin/text-idx?SID=7f94804791c87afdb06ef4e078b3199c&mc=true&node=pt21.5.314&rgn=div5#se21.5.314_153

The information required is as follows:

• NDA number
• Name of NDA sponsor
• Trade name of new drug
• Active ingredient(s) of new drug
• Strength(s) of new drug
• Dosage form of new drug
• Approval date of NDA or supplement
• patent number, issue date, and expiration date of patent submitted
• The patent owner's name, full address, phone number and, if available, fax number and e-mail address
• The name, full address, phone number of an agent or representative who resides or maintains a place of business within the United States authorized to receive notice of patent certification
• Information on whether the patent has been submitted previously for the new drug application
• Information on whether the expiration date is a new expiration date if the patent had been submitted previously for listing
• Information on whether the patent is a product-by-process patent in which the product claimed is novel
• Information on the drug substance (active ingredient) -Information on the drug product (composition/formulation)
• Information on each method-of-use
• Whether there are no relevant patents that claim the approved drug substance (active ingredient), the approved drug product (formulation or composition) or approved method(s) of use and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product
• A signed verification
• Information on whether the authorized official signed the form; the name of the person; and the full address

This relates to the CDT as much of this information is required for a submission in CDT format. Specifically, name of Sponsor, active ingredients, strength(s) of new drug, and dosage information.

The most important defined terms to understand prior to submission, in my opinion are Abbreviated Application and Application and specifically how they relate to each other and are different from each other. There are different requirements for each of these applications. The Abbreviated Application is outlined in Subpart C and is only applicable to certain drug products. I also think that it is important to highlight the differences between Class 1 Resubmissions and Class 2 Resubmissions. Class 1 Resubmissions are more minor in nature whereas, Class 2 Resubmissions requirereview in front of an advisory committee.