The U.S. Food and Drug Administration (FDA) seeks participation proposals for a pilot program involving tools that manufacturers and the agency can use to assess and measure the performance, safety and effectiveness of medical devices. Tool developers may begin submitting nominations for participation in the voluntary Medical Device Development Tools (MDDT) Pilot Program on September 15, 2014. According to FDA, agency-qualified MDDT tools can be “relied upon by the medical device industry in support of their device submission to the Agency, potentially reducing time and other resources needed to develop new products. This proposed voluntary qualification process is intended to enable submitters of MDDT proposals chosen for this pilot program to work closely with FDA to determine the amount and type of evidence and other information needed to support qualification for a specific tool and context of use.”
The U.S. Food and Drug Administration (FDA) requests comments on draft industry guidance titled “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.” The guidance is apparently “intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation At of 2009 (BPCI). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.” When finalized, the guidance “will represent the Agency’s current thinking on determining the date of first licensure for biological products filed under section 351(a) of the PHS Act,” a task that FDA characterizes as presenting “unique challenges.” Comments are requested by October 6, 2014.
The U.S. Food and Drug Administration (FDA) extends the comment period on draft guidance titled “Best Practices in Developing Proprietary Names for Drugs,” a document intended to help manufacturers develop and select proprietary names in a way that will minimize medication errors. FDA took the action in response to requests for additional time to submit comments, which are now due September 15, 2014.