With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are ...

Veeva Systems VEEV recently introduced SiteVault, a Clinical Trial Management System (CTMS) designed for research sites. It ...

A key result of a workshop series of European regulatory authorities and HTA agencies: Drug studies should be designed in such a way that they address both regulatory questions and the essential ...

Revenue for the year ended December 31, 2024, totaled $26.0 million, which included revenue recognized for the upfront fee, development milestones and cost reimbursements in connection with the ...

The integration of AI and cloud technologies is transforming pharmaceutical manufacturing regulations, focusing on safety, efficiency, and global harmonization.

Drug developers can now leverage large language models to draft regulatory documents, which they hope will shorten the time ...

Although the regulatory landscape for advanced therapy medicinal products (ATMPs) is rapidly evolving, varying regulatory ...

Clinical research agreements (CRAs) and developing a regulatory strategy—particularly in connection with the Food and Drug Administration ...

The filing and approval of an ANDS may be subject to requirements under the Patented Medicines (Notice of Compliance) Regulations and the data protection ... This section outlines technical clinical ...

It is recommended that sponsors contact VDD to request a pre-submission meeting to seek regulatory guidance on specific human safety data requirements prior to filing a submission: ...

A doctor has reviewed your general health, and your health meets study requirements. We have answered ... and reported according to federal law and good clinical practice regulations. Clinical trials ...