Monograph User Fee Program News Today

Minutes. Subcommittee on health will now come to order. Ill recognize myself five minutes for an Opening Statement. Todays hearing marks the Health Subcommittees first public discussion on modernizing the Current System at the United States food and Drug Administration to review, approve and update overthecounter drugs. This hearing provides us and the American Public with an opportunity to better understand the food and Drug Administrations Regulatory Framework to regulate overthecounter drugs ...

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022...

There were so many interesting and significant developments related to the various missions of the U.S. Food and Drug Administration (FDA) during the last week or so of September 2022...

The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, “Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs” (Meeting Guidance), that...

The US Food and Drug Administration (FDA) on February 1 issued a draft guidance, "Formal Meetings Between FDA and Sponsors or Requestors of OTC Monograph Drugs" (Meeting Guidance)...

By now, businesses operating in the over-the-counter (OTC) drug product space should all be familiar with the changes made by Congress to the regulatory system with the final OTC Monograph reform bill...

To embed, copy and paste the code into your website or blog: Last week, on December 29, 2020, the Food and Drug Administration (“FDA”) published a notice setting the amount of new annual facility fees for both for over-the-counter (“OTC”) monograph drug product manufacturers and for OTC monograph drug product contract manufacturing organizations (“CMOs”). The annual facility fee for OTC monograph drug manufacturers – the so-called Monograph Drug Facility (“MDF”) fee – was se...