• Regulatory NewsRegulatory News

    What Should a New Drug be Named? FDA Gives Industry More Time to Weigh in on Proposed Changes

    US regulators are giving the pharmaceutical industry more time to weigh in on a draft guidance released in May 2014 that seeks to establish how new drug products are given their "brand" names. Background The proprietary name for a drug is its "brand" name. For example, the erectile dysfunction drug sildenafil is marketed by Pfizer under the brand name "Viagra." In many cases, the brand name is easier to understand and recall for consumers and healthcare providers alike....
  • Regulatory NewsRegulatory News

    Regulators Extend Comment Period on Proposed Overhaul of Device Reclassification System

    The US Food and Drug Administration (FDA) is extending by several months the comment period on a proposed rule which would make it easier for the agency to classify and reclassify medical devices in accordance with their perceived risk. Background The proposed regulation is required under a 2012 law known as the  Food and Drug Administration Safety and Innovation Act (FDASIA) .  Section 608 of the law  called for FDA to be given the authority to make classificati...
  • As Supplement Industry Highlights Problems, FDA Reopens IND Guidance for Comment

    The US Food and Drug Administration (FDA) has reopened a comment period for a guidance document that aims to clarify the circumstances in which a research study involving human subjects may be conducted without first filing an investigational new drug application (IND) with the agency. Background: IND Basics The draft version of the guidance was released in September 2013, and is intended to make clear the cases when an IND is not required. In general, any investigat...
  • Industry Calls for Changes in Biosimilars Meeting Guidance to Protect Data, Provide Clarity

    In April 2013, the US Food and Drug Administration (FDA) released the fourth in a series of draft guidance documents related to the emerging regulatory framework for biosimilar products, a product classification first passed into law in 2010. Now industry is weighing in on that guidance, saying it needs several major changes in addition to a host of minor clarifications. Background Biosimilars were first identified as a unique regulatory classification under the 2010 P...
  • Medical Device Group Calls for More Transparency on Proposed Naming Conventions

    A medical device-focused scientific advocacy group is calling on the US Food and Drug Administration (FDA) to make changes to a recently proposed regulation set to make big changes to the way medical devices are tracked after being introduced to the market. In a statement on 11 October, the Emergency Care Research (ECRI) Institute said it is "concerned" about FDA's Unique Device Identification (UDI), set to come into effect within the next year. The rule -long delayed...
  • Extension Proposed for Comment Period on Important Medical Device Rule

    The US Food and Drug Administration (FDA) is proposing to extend the comment period on a proposed rule that would overhaul the way medical devices are overseen by regulators, it has announced. In July 2012, FDA released a long-awaited rule on a Unique Device Identification (UDI) system which would require most medical devices to carry an identification number and/or barcode capable of tracing the device back to its point of origin. Though the rule was mandated under l...
  • FDA Wants Industry Input on New Drug Review Process

    The US Food and Drug Administration (FDA) has released a call for comments on a new transparency and drug review program contained within the Prescription Drug User Fee Act V (PDUFA V), which is expected to be signed into law by President Barack Obama in July 2012. Specifically, FDA's Program for Enhanced Review Transparency and Communication for New Molecular Entity (NME) New Drug Applications (NDAs) and Original Biologics License Applications (BLAs) would "enhance re...
  • UPDATED: FDA Withdraws Final Rule After Receiving 'Significant Adverse Comment'

    • 26 June 2012
    Sometimes it takes just a single powerful argument to derail an intended final rule. The US Food and Drug Administration (FDA) announced on 27 June its withdrawal of a final rule as the result of a "significant adverse comment." The agency did not elaborate on the comment or its significance, but the intended final rule was published on 23 March 2012. Entitled, "Agreements and Memoranda of Understanding Between the Food and Drug Administration and Other Departments, Agen...