The guidance document aims to provide interested parties in particular notified bodies, device manufacturers, and medicinal product applicants, with appropriate guidance on procedural aspects to facilitate the consultation procedure to the Europe…

Too many women worldwide – particularly the poorest women – continue to die from cervical cancer; a disease that is both preventable and treatable. In order to help countries make faster progress, more equitably, on the screening and treatment of…

Turkish Medicines and Medical Devices Agency (TMMDA) issued guidance in order to determine the principles and procedures for the import of products to be used in clinical research studies conducted in the country. This guide is connected to th…

The US Food and Drug Administration (FDA) released draft guidance on bridging information on products featuring different combinations of drug-device and biologic-device combination products. The draft guidance can assist the sponsors to estab…

The Australian Therapeutic Goods Administration (TGA) has adopted a risk-based approach that’s applicable to the Fecal Microbiota Transplants (FMT). The TGA had earlier decided that all the FMT equipments would belong to various categories s…