Drugs

Generics Office Expands In-person Meetings

David McFarland

— 1 min read
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CDER’s Office of Generic Drugs (OGD) is expanding its post-pandemic return to in-person face-to-face (FTF) meetings with industry. Beginning 10/2, OGD will add the following meetings to the current FTF meeting option for the pre-ANDA product development and pre-submission meetings:

  • pre-submission product-specific guidance (PSG) meetings
  • post-submission PSG meetings
  • enhanced mid-cycle review meetings
  • post-complete response letter (CRL) scientific meetings

OGD also says it will offer a videoconference format for:

  • PSG teleconferences (t-cons)
  • mid-cycle review meetings
  • post-CRL clarification t-cons

“The availability of in-person FTF meetings may be limited by facility capacity and logistical considerations,” OGD says. “Meetings that otherwise are granted but that cannot be offered in an in-person FTF format will be conducted via videoconference.” Requests for an in-person FTF meeting must be part of the initial meeting request package received on or after 10/2.

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