FDA publishes two Draft IND Guidances for Comments

In December 2015 the Food and Drug Administration (FDA) published two draft guidances relating to investigational new drug applications (INDs). Comments and suggestions regarding the draft documents should be submitted within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

The draft guidance "Best Practices for Communications Between IND Sponsors and FDA During Drug Development - Guidance for Industry and Review Staff" was published on December 4, 2015. Additionally, a second draft guidance "Safety Assessment for IND Safety Reporting - Guidance for Industry" was published on December 16, 2015.

The draft guidance on "Best Practices for Communications Between IND Sponsors and FDA During Drug Development" describes

• FDA´s philosophy regarding timely interactive communication with IND sponsors as a core activity;
• The scope of appropriate interactions between review team and 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.

The draft guidance emphasizes that during the IND phase of drug development (e.g. time during which human trials of investigational drugs are conducted) "each year, sponsors and FDA engage in thousands of formal and informal communications, including meetings and teleconferences". Therefore, "it is important that interactions be conducted efficiently and consistently, with clear, concise and timely communication".

In general "complex scientific/technical, policy, or regulatory questions are best posed to FDA in either requests for formal meetings or in formal submissions". Timelines for FDA sending feedback to sponsors via the formal meeting process are described (among others) in FDA guidances and submissions often have regulatory-mandated timelines for reviewing and providing feedback to sponsors that are described by statute or regulation. For all other sponsor inquiries, (via telephone, email, or in a submission), that include specific questions for which sponsors are seeking FDA feedback, FDA strives to acknowledge such communications within 3 business days of receipt. Similarly, sponsors should acknowledge receipt of FDA´s information requests and provide FDA with an estimated response time.

The following "best practices and communication methods" are outlined in the draft guidance:

• Meetings between FDA and sponsors;
• Written correspondence from FDA;
• Submissions from Sponsors;
• Acknowledging receipt of communications;
• Email between FDA and sponsors;
• General telephone calls between FDA and sponsors;
• Faxes between FDA and sponsors;
• Use of Out-of-Office Messages by FDA and sponsors;
• Resources for sponsors.

Additionally, in certain limited circumstances, sponsors can directly contact one of the FDA´s resources listed in section "Additional Contacts" of the draft guidance. For further information, please find all the details in the Draft Guidance "Best Practices for Communications Between IND Sponsors and FDA During Drug Development".

The second draft guidance "Safety Assessment for IND Safety Reporting - Guidance for Industry" provides "guidance to sponsors on developing a systematic approach for investigational new drug application (IND) safety reporting for human drugs and biological products developed under an IND". The guidance is a follow-on to the guidance Safety Reporting Requirements for INDs and BA/BE Studies and is most applicable to sponsors managing a drug development program that has multiple studies. During the evaluation of comments to the draft guidance Safety Reporting Requirements for INDs and BA/BE Studies and at meetings with stakeholders, FDA identified the need for additional guidance on IND safety reporting. The draft guidance contains recommendations on:

• Composition and role of a safety assessment committee;
• Aggregate analyses for comparison of adverse event rates across treatment groups;
• Planned unblinding of safety data;
• Reporting thresholds for IND safety reporting;
• Development of a safety surveillance plan.

More information can be found in the draft guidance "Safety Assessment for IND Safety Reporting - Guidance for Industry".