FDA Plans to Focus on Tablet Scoring, Nanotechnology at Upcoming Meeting
| Posted: 13 July 2012
By Alexander Gaffney
The US Food and Drug Administration (FDA) plans to address tablet scoring and nanotechnology topics at an upcoming meeting in August 2012, the agency said.
In a 13 July 2012 Federal Register posting announcing the meeting, FDA explained that the meeting’s topics will include proposed draft guidance on tablet scoring released in August 2011 entitled, Tablet Scoring: Nomenclature, Labeling and Data for Evaluation.
The draft guidance directs sponsors of New Drug Applications and Abbreviated New Drug Applications on how to facilitate the evaluation and labeling of scored tablets, including data to include with an application and the nomenclature for approved scored tablets. In its posting, FDA said the meeting will “include an overview of FDA’s proposed plan to move forward and the United States Pharmacopoeia’s perspective on the topic.”
Tablets have frequently been the topic of several agency actions in recent months, with FDA warning generics manufacturers in January 2012 that tablet size must be identical to the reference listed drugs’. One month later, FDA rebuffed pharmaceutical manufacturer Warner Chilcott’s attempt to delay generic competitors for its Doryx acne pill, saying changes in the way the company had scored the reference product were not sufficient to delay its potential competitors, who did not have the same scoring marks on their tablets.
Focus on Nanotechnology
An afternoon session of the same meeting will discuss several topics related to nanotechnology, including an FDA working group on nanotechnology risk management, nanotechnology-related research conducted by FDA, and an “overview and preliminary analysis of nanotechnology-related information collected from drug application submissions.”
The agency recently released draft guidance on the use of nanomaterials in cosmetic products, and its Federal Register notice said discussion will include “examples related to sunscreen,” possibly looping in discussion of the guidance.
FDA Commissioner Margaret Hamburg wrote in April 2012 that the agency is considering additional guidance documents on the use of nanotechnology, but so far it is focused on providing a “nuanced” approach to regulation of the products.
The meeting will take place on 9 August 2012 at FDA’s White Oak Campus.
FDA - Meetings: Advisory Committee for Pharmaceutical Science and Clinical Pharmacology