Scientific-advice and meeting timelines
The writing of an advice request or meeting package is planned around the agency's clock, which sets when the request, the draft and the final package are due. In the US the clock depends on the formal-meeting type, and in Europe on the scientific-advice calendar, with its shorter and longer procedures and the clocks of its special procedures. These clocks change, so each interval holds for the date it is given.
The US formal-meeting clock
The sponsor requests a meeting and states its type, and the FDA usually responds on acceptance and format 14 to 21 calendar days after the request, depending on the type. The sponsor must then submit the meeting package, often called the briefing book, 30 to 50 days before the meeting, again depending on its type. Pre-NDA and pre-BLA meetings are usually held 6 to 12 months before the planned submission, to allow a comprehensive review of the summary of relevant data generated during development.
Medical writers most often work on FDA meeting types A, B and C, out of a range that also includes D and others. Type A is typically for a programme that has stalled: it discusses a clinical hold, a dispute or a special protocol assessment the sponsor has requested, possibly after the FDA has evaluated the protocol. It is scheduled within 30 days of the request, because a sponsor under a clinical hold needs feedback almost immediately. In one medical writer's account, type B covers the development checkpoints at which the sponsor aligns with regulatory expectations, namely pre-IND, certain end-of-phase-1, end-of-phase-2 or pre-phase-3, and NDA or BLA meetings, and it is typically scheduled within 60 days of the request. Type C is the formal discussion for non-urgent requests that fit neither, such as a change to the protocol design or to the statistical analysis plan, and it has 75 days from the request. The same account has the FDA expecting a type B package four weeks before the meeting. With the request at day 0 and the meeting at day 60, the strategy and the questions therefore have to be in place early, and the work planned so that time does not run out. The FDA guidance updated on 17 July 2024 gives other figures for type B: it sets the package no later than 30 days before the meeting, and it holds end-of-phase meetings within 70 days of the request.
The FDA sets meeting types by kind of product, such as biosimilars, generics and prescription drugs. Its guidance, updated on 17 July 2024, gives these intervals for prescription drugs, in days:
- Type A, for stalled development needing urgent FDA input, such as an important safety issue: answer to request 14, package with the request, preliminary response no later than 2 before the meeting, meeting within 30, minutes 30 after the meeting
- Type B, including pre-IND, pre-EUA and pre-BLA/NDA meetings and overall development under Breakthrough Therapy Designation, regenerative medicine and advanced therapy: answer to request 21, package no later than 30 before the meeting or written response only, preliminary response no later than 2 before, meeting within 60, minutes 30 after
- Type B end-of-phase, for end of phase 1 for products that will be considered for market approval, and end of phase 2 or pre-phase 3: answer to request 14, package no later than 50 before the meeting or written response only, preliminary response no later than 5 before, meeting within 70, minutes 30 after
- Type C, for any meeting other than A, B, D or INTERACT, which can be about product development or review: answer to request 21, package no later than 47 before the meeting or written response only, preliminary response no later than 5 before, meeting within 75, minutes 30 after; for consultation on new surrogate endpoints the logistics may differ
- Type D, for a narrow set of issues, fewer than two topics: answer to request 14, package with the request, preliminary response no later than 5 before, meeting within 50, minutes 30 after
- INTERACT, for very novel products and development programmes, such as pre-IND: answer to request 21, package with the request, preliminary response no later than 5 before, meeting within 75; in place of minutes, the preliminary responses are annotated and resent within 30 calendar days if the advice changes as a result of the meeting
Timing differs by type of interaction, and the health authority's feedback has to fit the sponsor's clinical development programme. These intervals are useful for setting the timeline for developing the briefing document.
The European scientific-advice calendar
Scientific advice and protocol assistance at the European Medicines Agency (EMA) typically follow the agency's procedure timeline, and checking the procedure dates that apply to the application is recommended. Procedures and requirements are subject to change, so the relevant agency's website should be consulted for current information.
In 2026 the timelines for submitting a briefing book are defined across the whole year and published on the EMA website, and the sponsor plans in advance the point in its development plan at which it will request advice, usually before a medical writer is involved. The application form must be submitted about two to three months before the intended start of the procedure, a preparatory meeting is sometimes requested to clarify the scope and content of the request, and the briefing book itself must be available a few days before the procedure starts. A medical writer asked to support the writing of a briefing book must keep to these timelines, as with any regulatory document.
From 17 November 2014 the EMA shortened the interval between the letter of intent and the start of the procedure, for applications starting from January 2015. The change covered scientific advice, parallel advice with health technology assessment bodies, protocol assistance and qualification of novel methodologies, and the interval became approximately three weeks where no pre-submission meeting was required and approximately seven weeks where one was. A draft briefing package was to be submitted with the letter of intent so that the procedure could start sooner, and the final package was still expected in the week before the start. So the draft package was due approximately three or seven weeks before the start of the procedure, depending on whether a pre-submission meeting was required.
In 2020 the letter of intent and/or a draft briefing document went to the EMA secretariat three weeks before the intended start, at day minus 20, or about seven weeks before, at day minus 45, where a pre-submission meeting was requested. Once they were forwarded to the Scientific Advice Working Party, two coordinators were appointed to manage the procedure. The working party met eleven times a year, with no meeting in August, so a missed submission deadline delayed the procedure by at least a month. The guidance called the submitted document a draft, but the applicant had to treat it as final, although the agency could still require changes. The initial phase ended with the working party's validation of the document and the applicant's submission of the final package through Eudralink, at day minus 3.
Once the procedure started, the coordinators reviewed the package and prepared a first report, and on that report the working party decided whether to adopt the advice without meeting the applicant, in the 40-day procedure, or to invite the applicant to a discussion meeting, in the 70-day procedure. The EMA sent its response at day 40 where the working party found no issues that required clarification, and at day 70 where it had further issues to be addressed in writing, at a discussion meeting or both. In the 70-day procedure the list of issues was addressed in a 90-minute meeting at around day 60. The meeting was usually face to face, but because of the COVID-19 pandemic it was held virtually until at least the end of 2020. The coordinators then sent their joint report to the EMA secretariat. After peer review by the working party, the Committee for Medicinal Products for Human Use (CHMP) and the EMA, the CHMP adopted the final advice letter and sent it to the applicant. The whole procedure took 60 to 115 days. Protocol assistance followed the same procedure.
Parallel advice and qualification procedures
The special procedures had clocks of their own. In 2020 parallel advice with the FDA took 110 to 135 days. The letter of intent and the draft meeting package went in between day minus 45 and day minus 20, together with both agencies' agreement to the request, and the final package at day minus 5. The two agencies met at day 30, within the working party's regular meeting schedule, both met the applicant at day 60, and the EMA responded at day 70 and the FDA at day 90.
In 2020 parallel consultation of the EMA and health technology assessment bodies took 150 days. The letter of intent went in at day minus 60, with the draft briefing package if a pre-submission meeting by teleconference was requested, and the draft briefing package, or the pre-submission teleconference, followed at day minus 30. Written comments on the draft briefing document were sent to the applicant at day minus 15, and the revised meeting package went in at day minus 2. After the procedure started at day 0, the list of issues was sent to the applicant at day 32, the written responses went in at day 45, and the presentation and list of participants at day 56. The EMA, the assessment bodies and the applicant met face to face at day 60, the EMA sent its response at day 70 on adoption by the CHMP, and the European Network for Health Technology Assessment sent its response at day 90.
In 2020 qualification of a novel methodology took 160 days for qualification advice and 250 for a qualification opinion. The letter of intent and a draft briefing document went in at day minus 60, a preparatory meeting with the EMA, face to face or by teleconference, was held at day minus 15, and the final package went in at day minus 3. The list of questions was sent to the applicant at day 30 and a discussion with the applicant followed at day 60, with further interactions possible by teleconference. Qualification advice was sent at day 100, while an opinion went through a public consultation from day 130 to day 190, with the response at day 190.