Drugs

OTC Drug Formal Meeting Guidance

FDA has published a draft guidance, Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs, with recommendations to industry on formal meetings between FDA and sponsors or requestors of nonprescription drugs without approved NDAs, known as over-the-counter (OTC) monograph drugs. The document specifies the principles and procedures for formal meetings between FDA and OTC drug sponsors or requestors.

The draft describes procedures under which meeting requestors can meet with appropriate agency officials to obtain advice on the studies and other information necessary to support Section 505G submissions, to obtain advice on other matters relevant to the regulation of nonprescription drugs, and to obtain advice on developing new OTC monograph drugs. It also specifies procedures to facilitate efficient participation in joint meetings by multiple meeting requestors and/or organizations nominated by them to represent their interests.

The guidance discusses the principles of good meeting management practices and describes standardized meeting procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings. It does not apply to meetings for developing nonprescription drug products intended for submission in NDAs or ANDAs under Section 505 of the Federal Food, Drug, and Cosmetic Act. And it does not apply to meetings between FDA and pre-investigational new drug or IND sponsors.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome