Joshua Taylor, PhD, RAC, Senior Director, Regulatory Affairs and Head of Clinical Strategy, Allucent
Matthew Hight, PhD, RAC, Associate Director, Regulatory Affairs, Allucent
Marcus Delatte, PhD, Vice President, Regulatory Strategy, Allucent
The Food and Drug Administration (FDA) issued an update on 30 January 2023 that clarifies the Agency’s position on and plan for face-to-face meetings.
Prior to the March 2020 COVID-19 pandemic, industry routinely met in-person with FDA staff at the White Oak campus. These formal meetings were offered under PDUFA (prescription drugs and biologics), MDUFA (medical devices), GDUFA (generics), BsUFA (biosimilars), and OMUFA (over-the-counter [OTC] monographs) agreements. Recently, the FDA (CDER and CBER) accepted a plan to move to a hybrid work environment in February, 2023, which allows scheduling in-person meetings.
What you need to know
- Timeline: On 13 February 2023, CDER and CBER staff resumed in-person meetings limited to Type A (drugs and biologics), BPD Type 1 (biosimilars), and Type X (OTC monographs) meetings. Other in-person meetings will be offered as CDER and CBER complete technology upgrades. No plan was provided for resuming in-person meetings with CDRH.
- Meeting Attendees: To avoid conference room overcrowding, the FDA is asking participants with key speaking roles to attend in-person and others to attend virtually.
- Technology Upgrades: FDA is upgrading their conference rooms with technology that includes noise-cancelling, boom-forming microphones, and conversation-tracking video cameras.
Allucent’s experts improve and hasten your regulatory filings and activities.
- Our 30+ years’ corporate and individual experience engaging with the FDA via in-person and virtual meetings position us to successfully support multiple formal FDA meetings each month.
- Our team of former FDA reviewers and industry veterans leverage their deep experience to prepare sponsors to successfully engage the FDA and to guide the narrative.
- We coordinate in-person rehearsal and debrief sessions for all participants to support successful FDA meetings, whether the meeting is fully remote or some participants attend in-person on FDA’s campus. In-person interactions promote:
- Collaborative participation and teamwork, which allows participants to read each other’s body language and facilitate efficient and effective discussions.
- Fluid engagement with each other, including side conversations that can be valuable for exchanging ideas and building consensus on how to mitigate program risks.
- Relationship building both within the industry team and between the sponsor and the FDA.
- Virtual rehearsal and debrief sessions are available as needed.
For more information about FDA meetings and how to efficiently and effectively prepare for and participate in them, contact Allucent’s regulatory team for guidance.
Allucent brings new therapies to light by solving the distinct challenges of small and mid-sized biotech companies. We’re a global provider of comprehensive drug development solutions, including consulting, clinical operations, biometrics, and clinical pharmacology across a variety of therapeutic areas. Our individualized partnership approach provides experience-driven insights and expertise to assist clients in successfully navigating the complexities of delivering novel treatments to patients. For more details about how the A-Team can support your drug development programs, visit us today.