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  • FDA Releases Extensive Final Q&A Guidance on Generic User Fees

    The US Food and Drug Administration (FDA) has released an updated question-and-answer document intended to assist sponsors and manufacturers of generic drug products approved via the 505(j) regulatory pathway with paying statutorily mandated user fees under the Generic Drug User Fee Act (GDUFA) . Background FDA is relatively unique among federal agencies in that the majority of its funding comes not from congressional appropriations, but rather from industry-paid user ...
  • ICH Publishes New Guideline on Clinical Study Reports

    The International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released a new question and answer document for its E3: Structure and Content of Clinical Study Reports ("The E3 Guideline") guideline. Writing on 21 June 2012, ICH said the document was finalized in mid-June as part of Step 4 of its Q&A Procedure process, indicating the document has reached consensus status and is in the proces...
  • FDA Releases Small Entity Compliance Guide for Informed Consent Elements

    The US Food and Drug Administration (FDA) released a guide to the informed consent process for sponsors, investigators and institutional review boards (IRBs) entitled Questions and Answers on Informed Consent Elements, 21 CFR §50.25(c) on 9 February 2012. The document provides 27 questions and answers regarding FDA's informed consent regulations that govern how patients must be informed of clinical trial information being entered in to a databank maintained by t...
  • New Q&A on Procedural Advice for Generic and Hybrid Product Applications Released by EMA

    The European Medicines Agency (EMA) released a new question and answer document on 25 January for applicants planning to use the Centralised Procedure to advance generic and hybrid product applications. The guidance "provides an overview of the EMA position on issues, which are typically addressed during the course of Pre-Submission Meetings." EMA stresses the "importance of Pre-Submission Meetings with applicants", which should take place 6 months before the planned d...