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  • Regulatory NewsRegulatory News

    Amgen Challenge of FDA Decision on Pediatric Exclusivity Could Have Wider Implications

    Back in May, the US Food and Drug Administration (FDA) denied a six-month extension of market exclusivity for Amgen's blockbuster Sensipar (cinacalcet), resulting in lawsuit filed by the drugmaker. A JAMA viewpoint published Wednesday argues that a decision in Amgen's favor could end up diminishing FDA's ability to encourage clinically meaningful pediatric studies. The case centers on the interpretation of how companies "fairly respond" to FDA's written requests ...
  • 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...
  • New Guidance Provides Framework on How to Keep a Drug the Same over Time

    A new draft guidance document released by the US Food and Drug Administration (FDA) is meant to clarify the analytical procedures and methods used to validate the production of drugs and biological products. Background The guidance was last issued in final form in 1987-26 years ago-and in draft form in 2000. Validation procedures and methods are important in the production of pharmaceutical products because they allow a company and regulators to say, with certainty, th...
  • Japan Joins Switzerland, Australia on List of Countries With API Quality Standards Equal to EU

    On 2 July 2013, new rules are set to go into effect in the European Union that radically change the process by which active pharmaceutical ingredients (APIs) manufactured outside the EU enter into the region. And while many countries are scrambling to get basic systems into place that will allow the manufacturers they regulate to meet the rules, Japan has now joined a small but elite group of nations that will be able to bypass many of the rules' most onerous provisions. ...
  • Legislation Introduced to Require 'Plain Writing' for all Regulations

    The US Food and Drug Administration (FDA) could be statutorily required to use "plain writing" in all of its future regulations if a piece of proposed legislation has its way. The proposed bill, The Plain Writing Act for Regulations of 2012 , would "require that Federal regulations use plain writing to enhance public understanding of regulations" in the hopes that such language would "increase the level of public participation in the rulemaking process." The bill, intr...
  • Analysis: FDA Warning Letters in 2011 Mostly Focused on Batch Failures

    An analysis of US Food and Drug Administration (FDA) warning letters issued in 2011 shows the majority of all facilities receiving a warning letter were deficient in areas relating to batch failure investigation , reports In-Pharma Technologist . "In the manufacturing-related warning letters analyzed by in-Pharma Technologist, FDA made 211 numbered observations," of which 10% were related to the company not investigating batch failures. Despite only 10% of all obs...