Committed to your success, from Concept to Approval.
The concept of substantial equivalence of medical devices was introduced by the US Food and Drug Administration
PMDA created a new regulatory pathway known as “SAKIGAKE” that allows the accelerated approval of drugs designated as breakthrough therapies and addressing unmet medical needs in Japan….
FDA encourages sponsors to consult the agency during their products’ development program through one of its 3 types of formal meeting (Type A, Type-B and Type-C). Each meeting has its own purpose and process….
Many 505(b)(2) applications do not require the sponsor to conduct nonclinical
studies. In these cases, the successful application will contain adequate
evidence of safety for the proposed product….