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  • FDA Moves Forward With Drug Labeling Revision Project

    The US Food and Drug Administration (FDA) is out with new information about an initiative first announced in 2013 that is meant to convert the labeling of hundreds of older drugs into a newer and consumer-friendly format. Background In 2006, FDA passed the Physician Labeling Rule (PLR), a labeling format intended to make it easier for physicians and patients to understand some of the most important benefits and risks of a drug. For example, labeling highlights under...
  • House Legislators Want FDA to Discuss 'Alternatives' to Generic Labeling Rule

    A large group of House Republicans is once against raising questions about the US Food and Drug Administration's development of a rule that would change the way generic drug labels are regulated, saying it has "significant questions" about the involvement of a group of trial lawyers in the process and is interested in proposing its own "alternative approaches." Interested in learning more about FDA's generic drug labeling rule? Check out our Regulatory Explainer o...
  • Regulatory Explainer: Understanding the Regulation of Generic Drug Labels

    Regulatory Focus'  ongoing series of  Regulatory Explainers  take complicated regulatory topics and make them simple enough for anyone to understand. In our latest Regulatory Explainer, we are taking a look at a new attempt by the US Food and Drug Administration (FDA) to change the way it regulates generic drug labeling and the controversy that it is causing within industry. Alright, Start From the Beginning: What's a Generic Drug? In general, most drug...
  • FDA Proposes Changes to Make Disclosure of Animal Drug Information Less Convoluted

    The US Food and Drug Administration (FDA) has issued a final regulation which it says will allow it to increase the transparency of its veterinary drug approval decisions. The 14 March 2014 announcement in the US Federal Register , a compendium of all regulatory decisions made by US government entities, aims to better work within an unusual statutory confinements. Background When a human pharmaceutical product is approved, the materials used to support its approval ...
  • In Response to Legislators, FDA Defends Proposed Generic Drug Labeling Rule

    The US Food and Drug Administration (FDA) is defending itself against critics of its proposed generic drug labeling rule, which would change the way generic drug manufacturers are able to update their labels to reflect emerging or established safety risks. Background Regulatory Focus  has written extensively about the  proposed rule , including its  legal background , initial  calls by legislators for reform , FDA's  early plans for a rule chan...
  • Opponents, Proponents of Generic Drug Labeling Rule Unleash New Arguments and Supporters

    As legislators prepare to debate the merits of a new proposal by the US Food and Drug Administration (FDA) to change the way generic drug labels are updated to reflect new safety risks, supporters on both sides of the debate are marshalling support for their arguments. Background Focus has written extensively about the proposed rule , including its legal background , initial calls by legislators for reform , FDA's early plans for a rule change , the reaction of l...
  • What's Holding up FDA's Electronic Drug Labeling Rule?

    Legislators with the two committees that oversee the US Food and Drug Administration (FDA) want to know: What's holding up the agency's electronic labeling rule for pharmaceuticals? Background Prescription drug labeling has been subject to standardization measures in the US since 1979, when measures to introduce uniformity were first passed. Those measures were substantially updated in 2006 under FDA's Requirements on Content and Format of Labeling for Human Prescript...
  • BIO Argues Changes Needed to FDA's Drug Shortage Rule to Account for Vaccines

    Should vaccines be considered under the US Food and Drug Administration's (FDA) recent drug shortages rule? No, argues the Biotechnology Industry Organization (BIO), which explained in a recent letter to FDA that the Centers for Disease Control and Prevention (CDC) has been able to adequately handle shortages of vaccines on its own for at least the last decade. Background Drug shortages emerged as a major issue in 2011 and 2012, with many generic sterile injectable drug...
  • Device Manufacturers Get New Option to Ensure Compliance with UDI Rule

    Medical device manufacturers looking to comply with the US Food and Drug Administration's (FDA) new Unique Device Identification (UDI) rule will now have a second accrediting agency from which to obtain an identifying mark. Background FDA released its final UDI rule in September 2013, reflecting a wide range of changes called for by industry. The rule, at its most basic, requires most medical devices to be given a unique identifying mark. The system has a number of all...
  • Jay Crowley, Author of FDA's UDI Rule, to Leave Agency for Industry Next Week

    Jay Crowley, the US Food and Drug Administration's (FDA) author of the Unique Device Identification (UDI) rule and a longtime employee of the agency, will soon retire to join industry, agency officials confirmed today. The news first broke on 19 December 2013, when USDM Life Sciences, a global regulatory consulting firm, announced that it had hired Crowley as its Vice President of its UDI practice. "There is nobody more qualified to help our medical device clients bec...
  • IMDRF Finalizes UDI Rule, Five Other Device-Related Documents

    The International Medical Device Regulators Forum (IMDRF) has announced the finalization of six documents pertaining to the marking of devices with unique identifiers, standardized definitions for medical software and extensive requirements for auditors participating in the single audit program. The IMDRF, launched in early 2013, is the regulators-only successor to the Global Harmonization Task Force (GHTF), a harmonization group that disbanded in 2012. Its current membe...
  • Industry Digs into Details of UDI Database Guidance in Comments to FDA

    Many of the medical device industry's biggest names have begun to weigh in on a new proposal from the US Food and Drug Administration (FDA) to launch a database intended to facilitate the operation of its Unique Device Identification (UDI) rule, offering a wide range of proposed changes. Background A  UDI  is, as its name implies, a system of identifying each medical device using a specific system. The system has a number of allures for regulators. "The uniqu...