York FaulknerFeb 28, 202113 minEastern District of Virginia Rocket Docket - Schedules & ProcedureTypical EDVA Case Schedule EDVA Local Rule 16(B) establishes four significant scheduling events along the short rode to trial before the...
York FaulknerFeb 26, 20216 minBiopharmaceuticals - Overview of FDA Regulatory StructureOne of the fastest growing categories of new FDA filings includes applications for the approval of biological drug products, which are...
York FaulknerFeb 25, 20218 minFDA Biologics License Application ("BLA")In contrast to regulations for new drug applications, which provide detailed explanations of the type and quality of information required...