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Jul 8, 2018

Guidance for pharmaceutical companies to prepare for UK’s withdrawal from EU
Publication of updated Q+As and practical guidance

The European Medicines Agency (EMA) and the European Commission have updated their guidance to help pharmaceutical companies prepare for the United Kingdom’s (UK) withdrawal from the European Union (EU). Updates to the questions-and-answers document are marked ‘NEW’.

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Two more EU Member States benefit from EU-US mutual recognition agreement for inspections
Agreement now operational between 14 EU Member States and FDA

The mutual recognition agreement between the European Union (EU) and the United States (US) to recognize inspections of manufacturing sites for human medicines conducted in their respective territories has made further progress.

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New FDA Draft Guidance on Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials
Draft Guidance published for receiving comments within 60 days

The purpose of this guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards (IRBs) with information to facilitate the inclusion of adolescent patients (for purposes of this guidance defined as ages 12 to 17) in relevant adult oncology clinical trials. FDA recommends the inclusion of adolescents in disease- and target-appropriate adult oncology trials to enable earlier access to investigational and approved drugs2 for adolescent patients with cancer. Considerations that are discussed in this guidance include:

  • Appropriate criteria for the inclusion of adolescent patients in adult oncology trials at various stages of drug development
  • Dosing and pharmacokinetic (PK) evaluations
  • Safety monitoring
  • Ethical requirements

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Re-issuing of USFDA Draft Guidance on Formal Meetings Between the FDA and Sponsors or Applicants of BsUFA (Biosimilar User Fee Act) Products
Comments are encouraged within 90 days of issuance

The original guidance was issued in 2015 and was then called: “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants”, but was withdrawn in the same year. This guidance was issued new and provides recommendations to industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or applicants relating to the development and review of biosimilar or interchangeable biological products regulated by the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER). This guidance does not apply to meetings associated with the development of products intended for submission in, or with the review of, new drug applications or abbreviated new drug applications under section 505 of the Federal Food, Drug and Cosmetic Act (FD&C Act), biologics license applications (BLAs) under section 351(a) of the Public Health Service Act (PHS Act), or submissions for devices under the FD&C Act. For the purposes of this guidance, formal meeting includes any meeting that is requested by a sponsor or applicant (hereafter referred to as requester(s)) following the procedures provided in this guidance and includes meetings conducted in any format (i.e., face to face, teleconference/videoconference, or written response only (WRO)). This guidance discusses the principles of good meeting management practices (GMMPs) and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.

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