From 13-14 November 2018 in Berlin: The ICH Steering Committe published the new ICH Q12 Guideline on "Product Life Cycle Management" only recently. Learn from industry experts, authority speakers and 3 Members of the ICH Q12 Expert Working Group about the new guideline.
The evaluation of the FDA warning letters regarding medical devices of the first half of fiscal year 2017 yielded a remarkable low number of warning letters. Find out, what the evaluation of the medical devices warning letters in the first half of fiscal year 2018 showed.
On twelve pages, the new FDA guideline entitled "Classification of Products as Drugs and Devices and Devices and Additional Product Classification Issues: Guidance for Industry" describes how the FDA classifies products as drug products, medical devices or others.
On 76 pages spread over five chapters, the WHO has published a finalised regulatory framework for medical devices, including In-vitro-Diagnostics (IVDs), with the title "WHO Global Model Regulatory Framework for Medical Devices Including in Vitro Diagnostic Medical Devices".
The final FDA guidance provides recommendations regarding the required documentation related to the control of elemental impurities consistent with ICH Q3D and USP General Chapters <232> and <233>. Read more about FDA´s guidance on Elemental Impurities in Drug Products, which applies to manufacturers of noncompendial and compendial drug products.
The European Medicines Agency (EMA) has published a press release and announced the next phase of its business continuity plan. According to this release the Agency will need to further scale back and suspend activities.