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  • Dear Tushar, You suggest that the oldest approved product on the EU market should be used as reference product under an abridged application via the generic route. However, this is only possible if the reference product was originally licenced under the European legislation dating from 1968 so this possibility is not available if the reference is older ...

  • Thanks dearly for your response! ------------------------------ Sofia Panagou QA/RA Manager Leoni Fiber Optics Gmbh Berlin Germany ------------------------------

  • Technically, FDA has no legal authority to ask you to submit a piece that truly is advertising.  However, the reviewer might take the position that advertising is a subset of labeling and ask to review certain pieces that you might view as not traditionally in the labeling category (e.g., user guides, instructions for use, etc.).   Whether to resist ...

Rainer Voelksen, FRAPS, Talks Volunteering and European Advisory Committee

"Regulatory professionals need to hear the voices of those working in other countries. Just helping others to get used to hearing other languages is important, and you can be a cultural representative at the table in any stage of your career. The regulatory industry is increasingly global, but all regulators work differently. We must all work harder to become comfortable sharing information in an international space so that the industry can successfully continue to develop."

Rainer Voelksen, FRAPS


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