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  • Feature ArticlesFeature Articles

    A mandatory dietary supplement registry: Transparency as ‘disinfectant’

    The Dietary Supplement Health and Education Act struck a balance between protecting public safety and promoting consumer access to dietary supplements, but it did not address the Food and Drug Administration’s inability to “see” into the marketplace. This article discusses how a mandatory product listing can benefit the industry through increased transparency and accountability. It outlines criticisms from industry skeptics and provides considerations for legislation of th...
  • Regulatory NewsRegulatory News

    Product Hopping: E&C Hearing Addresses Restrictions to Generic Competition

    A subcommittee of the House Energy & Commerce Committee held a hearing on Thursday raising questions around some of the tactics pharmaceutical companies use to block competition, including the controversial use of product hopping. Product hopping, which involves companies reformulating drugs to restrict competition, can include many different types of reformulations, such as a change from a capsule to a tablet, a change in dosing or strength or a reformulation to an ext...
  • Regulatory NewsRegulatory News

    FDA Again Pushes Back Compliance Date for Safety Reporting Requirements for Combo Products

    A little more than a year after pushing back the date by which combination product companies must comply with certain postmarket safety reporting (PMSR) requirements, the US Food and Drug Administration (FDA) on Tuesday extended the compliance deadline again. The updated guidance explains how FDA does not intend to enforce 21 CFR 4.102(c) and (d) (constituent part-based PMSR requirements), 4.104(b)(1) and (b)(2) (submission process for constituent part-based Individual ...
  • Regulatory NewsRegulatory News

    Combo Product Reviews: FDA Drafts Guidance

    The US Food and Drug Administration (FDA) on Tuesday released high-level draft guidance explaining the principles for premarket review of combination products, including how sponsors can determine which type of premarket submission is appropriate. The 22-page draft, which implements a section of the 21 st Century Cures Act , explains what combination products are, how their various FDA center assignments are determined and considerations for making approval pathway de...
  • Regulatory NewsRegulatory News

    Physicians’ Favorable Views of FDA Drug Approval Standards Underscore ‘Disconnect,’ Survey Finds

    A research letter published in JAMA Internal Medicine on Tuesday highlights the “disconnect” between many physicians’ perceptions of the US Food and Drug Administration (FDA) drug approval process and the “current reality.” The findings are based on a survey aimed at gaging physicians’ attitudes toward FDA drug approval standards and off-label promotion, with a total of 686 survey (48% response rate) respondents listed by the American Board of Internal Medicine Diplom...
  • Regulatory NewsRegulatory News

    Industry Comments on ICH Product Lifecycle Management Guideline

    The European Medicines Agency (EMA) on Friday released comments gathered during its public consultation for the International Council for Harmonisation's (ICH) draft guideline on pharmaceutical product lifecycle management.   The 31-page draft guideline , ICH Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management , was adopted by ICH and released for public consultation last year.   Most of the comments EMA received express...
  • Regulatory NewsRegulatory News

    FDA Withdraws Proposed Rule on Generic Label Changes

    The US Food and Drug Administration (FDA) on Thursday withdrew a proposed rule on label changes for generic drugs after concerns were raised by commenters and FDA resources were considered. The proposed rule from 2013 would have allowed abbreviated new drug application (ANDA) holders for generic drugs to independently update and promptly distribute revised product labeling to reflect newly acquired safety-related information, even if the revised labeling may temporarily...
  • Regulatory NewsRegulatory News

    Stage Set for Merck’s SCOTUS Case Over Warnings in Labels

    With the acting solicitor general set to participate in oral arguments before the Supreme Court on 7 January, the high court will be deciding a contentious case centered on who has the final say in warning labels on pharmaceuticals. The case, known as Merck v. Albrecht , presents the question of whether Merck should be held liable for failing to warn about the side effects of an osteoporosis drug, despite attempting to change the warning label and having FDA reject its...
  • Regulatory NewsRegulatory News

    New Product-Specific Guidances Focus on Drugs Without Generic Competition

    The US Food and Drug Administration (FDA) on Tuesday issued 63 new and revised draft product-specific guidances detailing its expectations for companies looking to develop generic versions of those products.   Of the 63 guidances, 22 are new draft guidances and 41 are revised draft guidances. According to FDA Commissioner Scott Gottlieb, nearly 70% (43) of the guidances are for products that do not have any generic competition.   Some of the newly released draft gu...
  • Regulatory NewsRegulatory News

    European Commission Revises Q&A on Safety Features for Medicinal Products

    The European Commission on Monday released a revised question and answer document regarding the implementation of the rules on the safety features for medicinal products for human use. Revisions in the document are related to two questions and answers, including one on if a pack bearing safety features is lawfully opened by, for instance, parallel traders or manufacturers replacing the leaflet, can the pack be resealed? The answer notes that in certain circumstances it ...
  • Regulatory NewsRegulatory News

    FDA Plots Policy Priorities for 2018

    The US Food and Drug Administration (FDA) on Thursday announced its priorities for policy activity in 2018, which will include reducing the misuse and abuse of opioids, promoting generic drug and biosimilar competition, creating a total product lifecycle office for medical devices, advancing digital health technologies and strengthening the agency’s workforce. “Our work is taking place during an inflection point in both science and policy,” FDA Commissioner Scott Go...
  • Regulatory NewsRegulatory News

    Ruling Against Novartis Could Have Wider Implications for Generic Drug Labels

    California's Supreme Court on Thursday ruled against Novartis in a decision that could have wider implications for whether brand-name or generic drugmakers should be held liable for warning consumers of risks in their drug labels. In a departure from other recent rulings, the highest California court found that a brand-name drug manufacturer's duty to warn consumers does extend to a generic, but only because federal regulations currently require generic drugs to carr...