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| Date | Title of guidance and link to document | Type and level of guidance | About the guidance |
|---|---|---|---|
| 15 Jul 2026 | Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs | Final, Level 1 | This guidance provides recommendations to industry on formal meetings between the FDA and sponsors or requestors of nonprescription drugs without approved new drug applications that are governed by section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) or organizations nominated by sponsors or requestors to represent their interests in a proceeding. For the purposes of this guidance, a formal meeting includes any meeting that is requested by a sponsor or requestor of OTC monograph drugs or organizations nominated by sponsors or requestors to represent their interests in a proceeding to obtain advice on the studies and other information necessary to support OTC monograph order submissions, to obtain advice on other matters relevant to OTC monograph drug regulation, or to obtain advice on OTC monograph drug development and includes meetings conducted in any format (i.e., hybrid in-person face-to-face, virtual face-to-face video conference, teleconference, and written response only (WRO). |
| 1 Jul 2026 | Submitting Next-Generation Sequencing Data to the Division of Antiviral Products | Final, Level 2 | The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antivirals regarding the submission of next-generation sequencing (NGS) protocols, data, and analyses in support of resistance assessments for the development of antiviral drugs. |
| 1 Jul 2026 | Submitting Next-Generation Sequencing Data to the Division of Antiviral Products | Final, Level 2 | The purpose of this technical specifications document is to provide the current thinking of FDA’s Division of Antivirals (the Division) regarding the submission of next-generation sequencing (NGS) protocols, data, and analyses in support of resistance assessments for the development of antiviral drugs. |