On December 9, 2015, the FDA announced the release of a draft guidance entitled, “Best Practices for Communication Between IND Sponsors and FDA During Drug Development.” The guidance attempts to promote timely, transparent, and effective communication between IND sponsors and the FDA.
The draft guidance includes the following best practices for FDA communication with IND sponsors:
- “FDA’s philosophy regarding timely interactive communication with IND sponsors as a core activity.
- The scope of appropriate interactions between the review team and the sponsor.
- The types of advice appropriate for sponsors to seek from FDA in pursuing their drug development program.
- General expectations for the timing of FDA response to IND sponsor inquiries.
- Best practices and communication methods to facilitate interactions between the FDA review team and the IND sponsor during drug development.
- Expectations for appropriate methods, including the frequency, of such communications.”
Meeting Types & Best Practices
In the draft guidance, the FDA states that “effective and timely communication between FDA and sponsors promotes understanding of mutual goals and is invaluable to the drug development process. Central to this is the ability to communicate clearly, both orally and in writing, inside and outside the formal meeting format.” As such, the Agency will abide by the following best practices when communicating with sponsors of IND applications:
- “As a best practice, FDA staff will use words such as shall, must, required, or requirement to convey a statutory or regulatory requirement.
- As a best practice, FDA staff will use the following words to communicate advice (e.g., on trial design), comments, or current thinking often include the following terminology: advisable, critical, important, may be appropriate, should, consider, discourage, encourage, prefer, recommend, suggest, or urge. Because FDA has the advantage of viewing the spectrum of drug development across sponsors, indications, and drug classes, FDA is able to communicate advice to sponsors with that expertise in mind, while upholding commercial confidentiality.”
FDA meetings are essential for both sponsors and the Agency. They help resolve questions and issues that may come up during drug development and allow sponsors to confirm that they are on the same page as the FDA. In order for sponsors to achieve efficient drug development, it is absolutely critical that they learn FDA’s views on all applicable requirements prior to submitting an application.
The draft guidance states that these meetings occur at critical points in drug development, and include:
- “Pre-IND meetings are valuable for understanding proof of concept and initiating dialogue for drug development in its early stages. They can prevent clinical hold issues from arising and aid sponsors in developing a complete IND submission. FDA encourages sponsors to request a pre-IND meeting for the following: a drug not previously approved/licensed, a new molecular entity (NME), a planned marketing application intended to be submitted under the 505(b)(2) regulatory pathway, drugs for which it is critical to public health to have an effective and efficient drug development plan (e.g., counter-terrorism), drugs with substantial early development outside the United States, a planned human factors development program, and drugs with adequate and well-controlled trials to support a new indication. However, a sponsor of any IND can request a pre-IND meeting. Because of limitations of FDA resources, it is common for review divisions to use the WRO meeting procedures for pre-IND meetings; however, in selected circumstances a face-to-face meeting or teleconference may be granted.
- EOP1 meetings are useful to review and reach agreement on the design of phase 2 controlled clinical trials and to discuss issues related to the proposed drug development program, including pediatric study plans, as appropriate. Because of limited resources, FDA has traditionally encouraged sponsors to request an EOP1 meeting only for drugs intended to treat life-threating and severely debilitating illnesses, particularly situations where approval based on phase 2 trials or accelerated approval may be appropriate.
- EOP2 meetings are of considerable importance in planning later studies and in determining the safety of proceeding to phase 3. EOP2 meetings evaluate the phase 3 plan and protocols, the adequacy of current studies and plans to assess pediatric safety and effectiveness, the human factors validation plan, and identify any additional information necessary to support a marketing application for the uses under investigation. FDA encourages sponsors to request an EOP2 meeting for NMEs or major new uses of marketed drugs. However, a sponsor of any IND can request an EOP2 meeting.
- Pre-NDA/BLA meetings are helpful in acquainting FDA reviewers with the format and content of the planned application, including labeling and risk management activities (if applicable), presentation and organization of data, data set structure, acceptability of data for submission, as well as the projected submission date of the application. They are also intended to uncover major issues, identify studies intended to establish the drug’s safety and effectiveness, discuss the status of pediatric studies, and discuss appropriate statistical analysis methods, or results of analyses. FDA encourages sponsors to request pre-NDA/BLA meetings for all planned marketing applications, particularly applications to be reviewed under the PDUFA V Program for Enhanced Review Transparency and Communication for NME NDAs and Original BLAs.”
The draft guidance also provides a comprehensive list of best practices for meeting-related communication between sponsors and the FDA. A full list of meeting-related best practices is available here.
In addition to meeting-related best practices, the draft guidance provides sponsors with additional recommendations regarding:
- Written Correspondence from FDA,
- Submissions from Sponsors,
- Acknowledging Receipt of Communication,
- Email Between FDA & Sponsors,
- General Telephone Calls Between FDA & Sponsors,
- Faxes Between FDA & Sponsors,
- Use of Out-of-Office Messages by FDA & Sponsors, and
- Resources for Sponsors.
Additional details on best practices for FDA communication with IND sponsors are available in the draft guidance, which can be found here.
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