• Regulatory NewsRegulatory News

    Vanda Pharmaceuticals Sues FDA Over Partial Clinical Hold

    In a complaint filed against the US Food and Drug Administration (FDA), Vanda Pharmaceuticals called on a federal district court to lift a partial clinical hold on its experimental drug tradipitant. The complaint—filed with US District Court for the District of Columbia on Tuesday—alleged that FDA acted in violation of the Administrative Procedure Act of 1946 (APA) in imposing the partial clinical hold last December. The hold was imposed on a protocol for a new clinic...
  • Regulatory NewsRegulatory News

    ICH Seeks to Harmonize Generic Drug Standards

    With an aim to harmonize the technical and scientific standards for generic drugs across borders, the International Council on Harmonization (ICH) on Wednesday released a reflection paper outlining an approach to begin supporting such efforts. The reflection paper offers recommendations to develop a series of ICH guidelines on standards for demonstrating bioequivalence for non-complex and more complex dosage forms and products. It also describes the remit of the Informa...
  • Regulatory NewsRegulatory News

    FDA Offers ICH S11 Guidance for Comment as Shutdown Threatens Further Guidance

    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance, developed by the International Council for Harmonisation (ICH), on the standards for nonclinical safety studies in the development of pediatric medicines. The 38-page guidance should be consulted for study design, and early consultation is recommended for consideration of nonclinical support for pediatric medicine development. The guideline lays out advice on determining the need for additional ...
  • 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

    ICH Updates on Guidelines, Future Topics

    The International Council for Harmonisation (ICH) on Friday said it has made “significant progress” on new and existing guidelines following a weeklong meeting in Charlotte, North Carolina earlier this month.   ICH also said it has finished implementing the reforms set out in 2015 to make the organization more global.   “Three years on from the reform of ICH, all organizational changes have been implemented,” ICH writes, noting that its membership has grown to incl...
  • Regulatory NewsRegulatory News

    FDA Consults on ICH Biopharmaceutics Classification System-Based Biowaivers Guideline

    The US Food and Drug Administration (FDA) on Thursday released its version of the International Council for Harmonisation (ICH) biopharmaceutics classification system (BCS) -based biowaivers guideline for consultation.   The draft guideline, which reached Step 2b of the ICH process in June, is currently under consultation by the group’s regulatory members and is expected to be adopted in May 2019. FDA is asking interested parties to submit their comments on the guideli...
  • Regulatory NewsRegulatory News

    Updated: ICH Updates on MedDRA, New Members and Guidelines

    The International Council for Harmonisation (ICH) on Thursday provided guidance and other updates, inaddition to news on developments for the Medical Dictionary for Regulatory Activities (MedDRA), following a recent meeting of the MedDRA management committee in Geneva, Switzerland. MedDRA was initially developed by ICH in the late 1990s to provide standardized medical terminology for regulatory purposes and is available at no cost to regulators and to drugmakers on a sli...
  • Regulatory NewsRegulatory News

    Reproductive Toxicity: FDA Consults on Revised ICH Guideline

    The US Food and Drug Administration (FDA) on Thursday released a draft guidance for consultation on a revision to the International Council for Harmonization (ICH) guideline on reproductive toxicity testing. The draft ICH guideline, S5(R3) Detection of Toxicity to Reproduction for Human Pharmaceuticals , was endorsed by the ICH Assembly in August and is currently in Step 3 of the formal ICH procedure as participating regulators hold public consultations on the guideline...
  • Regulatory NewsRegulatory News

    FDA Opens for Comment Revised ICH Guideline on Statistical Principles for Clinical Trials

    The US Food and Drug Administration (FDA) on Monday opened for comment a newly revised International Council for Harmonisation (ICH) guideline intended to better align the choice of statistical methods with questions of regulatory importance, and to improve the reliability of decisions about and representations of the effects of medical products. The 31-page draft guidance, according to FDA, clarifies, updates and extends the earlier ICH guidance, entitled "E9 Stati...
  • Regulatory NewsRegulatory News

    ICH Transparency: New Info on Funding, Expert Working Groups

    The International Council for Harmonisation (ICH) on Monday began a push toward more transparency, with the release of which members make up its expert working groups and new data on how ICH is funded. "While these experts represent the regulatory and industry association parties that nominate them, this new level of transparency will bring a novel understanding of who contributes to the development of guidelines as well as the roles they play," ICH said. Accord...
  • Regulatory NewsRegulatory News

    FDA Offers New ICH Guidance on Organizing a CTD

    The US Food and Drug Administration (FDA) this week released a guidance that is part of a series from the International Council of Harmonisation (ICH) on the format for preparing the Common Technical Document (CTD) for applications submitted to FDA. "A common format for the technical documentation will significantly reduce the time and resources needed to compile applications for registration of human pharmaceuticals and will ease the preparation of electronic subm...
  • Regulatory NewsRegulatory News

    ICH Plans Work on Clinical Trials Guideline Revision, Pediatric Extrapolation

    The International Council for Harmonisation (ICH) is planning to take up two new topics, according to the minutes released Thursday from the group's meeting in Montreal in May and June. The two topics include the first revision to ICH's 1997 E8 General Considerations for Clinical Trials and a new guideline on pediatric extrapolation in clinical trials, both proposed by the US Food and Drug Administration (FDA). The ICH Assembly also adopted concept papers outlines f...