• Regulatory NewsRegulatory News

    FDA officials address common pitfalls affecting post-approval change applications

    The US Food and Drug Administration (FDA) offered some advice to help ensure smoother reviews of abbreviated new drug application (ANDA) post-approval supplements and addressed how certain changes should be categorized at the 10 November meeting of the Association for Accessible Medicines” (AAM) GRx+Biosim conference.   Officials were asked to address common issues affecting ANDA post-approval chemistry, manufacturing and controls (CMC) submissions. Agency officials ...
  • Regulatory NewsRegulatory News

    FDA extends comment period on ICH Q12 guidance

    The US Food and Drug Administration (FDA) has reopened the comment period on its draft guidance implementing the International Council for Harmonization’s (ICH) Q12 guideline on postapproval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceuticals and drug substances.   The additional time was requested by the Pharmaceutical Research and Manufacturers of America (PhRMA).   FDA announced in a pre-publication notice in the 8 Septembe...
  • Regulatory NewsRegulatory News

    EMA guidelines highlight changes to IMPs triggering notification to regulators

    The European Medicines Agency (EMA) on 1 July released for public consultation two draft guidelines to help sponsors of investigational medicinal products (IMPs) for new drugs and biologics decide whether manufacturing changes are considered a “substantial modification” needing prior approval.   These guidelines are connected to the EU regulation No. 536/2014 which came into force on 20 June 2014. The regulation defines a “substantial modification” as any change to a...
  • Feature ArticlesFeature Articles

    Enhancing consumer confidence and supplement access through harmonized retail standards

    Although third-party audit, certification, and retail standard programs highlight reputable companies and help ensure that dietary supplements on store shelves are safe and unadulterated, multiple standards create a complicated patchwork of requirements that are difficult for manufacturers and consumers to navigate. Responsible industry has emphasized the need to harmonize standards by eliminating duplicative, costly testing and allowing retailers to confirm a manufacturer...
  • Regulatory NewsRegulatory News

    FDA issues final guidance on CMC postapproval changes for biologics

    The US Food and Drug Administration (FDA) on Monday issued a final guidance to assist manufacturers of biological products in determining which types of changes to their products should be submitted in an annual report and which will require a prior approval supplement, the highest reporting category.   The guidance contains minor changes from a draft issued in December 2017; no reporting changes were switched from the minor to major category. Licensed biological produ...
  • 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

    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

    Drugmakers Critique FDA Draft Guidance on Postapproval Changes for Drug Substances

    More than a dozen drugmakers have offered comments on the US Food and Drug Administration’s (FDA) draft guidance on postapproval changes for drug substances, with some offering changes and others calling for the document to better reflect guidance from the International Council for Harmonisation (ICH). The draft guidance covers facility, scale and equipment changes associated with all steps of drug substance manufacturing; specification changes to starting materials, ra...
  • 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...
  • Regulatory NewsRegulatory News

    CMC Changes for Biologics: FDA Offers Draft Guidance

    The US Food and Drug Administration (FDA) on Thursday released draft guidance intended to help applicants and manufacturers of certain licensed biological products in determining which reporting category is appropriate for a change in chemistry, manufacturing, and controls (CMC) information to an approved biologics license application (BLA). Based on a tiered-reporting system for specific changes, the 43-page draft provides applicants and manufacturers with general...
  • Regulatory NewsRegulatory News

    FDA: Aspirin Manufacturers' Cardio Imagery is OK if Label Statement Included

    The US Food and Drug Administration (FDA) on Monday said that it does not intend to take action against certain manufacturers of over-the-counter (OTC) aspirin products because the label includes cardiovascular-related imagery (e.g., heart image, electrocardiography graphic, stethoscope around a heart image) if the label also includes language as described in guidance finalized Monday. "Because of the potential side effects associated with long-term aspirin therapy...