For small startups and academic spinoffs bringing their first molecules to market, reaching the clinic represents a major milestone. Reducing the time to investigate a new drug (IND) filing can help ...

Global harmonization of CMC guidelines is a key focus for top pharmaceutical consultants. Variations in regulatory requirements across regions often create inefficiencies in drug development—for ...

Industry stakeholders are asking the US Food and Drug Administration (FDA) to provide more details on how informal communications can be used, expand the use of a pre-submission template, and to ...