FDA Generic Drugs Office Advances QbD, Review Processes and QM System in Anticipation of User Fees
FDA’s Office of Generic Drugs (OGD) is making significant strides forward in its efforts to implement quality by design (QbD), refine its review processes and implement a quality management system, in anticipation of the resource underpinning that user fees will provide. Read on.
Revision of the European Variations System: EU Commission publishes the Outcome of the Public Consultation
The scope of the European Variations Regulation should be extended to purely national authorisations. A concept paper on the question was published by the EU Commission in September 2011. On February, 1st, 2012, the Commission published the outcome of this consultation on its website. Read more here.
New Questions and Answers about the Centralised Procedure - EMA publishes an Updated Q&A Document
The European Medicines Agency (EMA) has updated the Questions & Answers document. Current topics regarding the centralised procedure for generic/ hybrid applications have been incorporated. Read more about the questions and answers.