A 505(b)(2) New Drug Application (NDA) is a submission to the Food and Drug Administration (FDA) for approval to market a drug in the USA. It differs from a ‘stand-alone’ NDA in that some of the data on which the applicant relies to demonstrate safety and efficacy have been obtained from publicly available sources rather […]
New course on the 505(b)(2) application for marketing approval in the USA Read More »
Biological products have come to dominate the market for medicines in recent decades. To introduce a biological product into interstate commerce in the USA, the sponsor of the product must gain FDA approval of a Biologics License Application (BLA). This enormous compilation of information and data is the culmination of years of effort and financial
New course on the Biologics License Application (BLA) Read More »
Our courses are undergoing a rolling programme of Continuing Professional Development accreditation by the well-respected CPD Certification Service (CCS). CCS reviewers carefully assess each course before deciding whether to grant certification, and it will take some time to assess the full Zenosis library. To date, learners that successfully complete the following courses will receive a
Accreditation update Read More »
The European Union, recognising that many medical device manufacturers would be unable to meet the deadline for transition to the requirements of the Medical Device Regulation (MDR), have extended the grace period allowed for compliance with the new law. Prominent among the reasons for the postponement of the deadline is the inadequate number of third-party
EU extends grace period for transition to Medical Device Regulation Read More »