Plan Carefully In Writing Combo Product Designation Requests, US Experts Say
This article was originally published in Clinica
Companies need to carefully consider tactics for ensuring proper regulation of combination products in the US, including looking at whether they really need a formal request for designation (RFD), say industry and legal experts.
You may also be interested in...
India’s Sun Pharma has been denied leave to appeal against a US court decision rejecting the company’s bid for dismissal of a multi-district antitrust lawsuit.
Former Sandoz executive Hector Armando Kellum has admitted involvement in a US generic price-fixing conspiracy, the US Department of Justice has announced.
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.