Industry Pushback on : Biosimilar, Biological medicines Industry, Food and Drug Administration, Generic Drug

Industry Pushback on FDA's Proposal for Biosimilar Product-Specific Guidance

The U.S. Food and Drug Administration (FDA) recently proposed issuing biosimilar product-specific guidance to streamline the approval process for biosimilars. While this move aims to make the pathway for biosimilar approvals more predictable and accessible, it has faced pushback from the pharmaceutical industry. Many industry leaders argue that this approach could inadvertently hinder innovation, increase regulatory burdens, and complicate the pathway to biosimilar market entry.

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA. The Generic Drug User Fee Amendments (GDUFA) provides a framework for improving the efficiency and transparency of the review process for generic drug applications, known as Abbreviated New Drug Applications (ANDAs). One key aspect of this framework is the review of Drug Master Files (DMFs), which are critical for ANDA submissions involving drug substances, intermediates, or excipients that are not fully described in the ANDA itself.

US FDA Publication on Integrating Artificial Intelligence into Healthcare Product Copy

Clinical Trials for Drugs/Medicines in Brazil and the Clinical Trial Application process

On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.

“Electronic Submission Now Available for Investigational New Drug Application (IND) Safety Reports”

The FDA has issued a reminder to drug sponsors and researchers regarding its recent publication of guidance outlining the process for electronically submitting investigational new drug application (IND) safety reports to the FDA Adverse Event Reporting System (FAERS). IND individual case safety reports (ICSRs) can now be submitted electronically through either the Electronic Submission Gateway in ICH E2B (R3) format or via the Safety Reporting Portal, with the FDA now accepting such submissions.

US FDA Publication on Integrating Artificial Intelligence into Healthcare Product

Clinical Trials for Drugs/Medicines in Brazil and the Clinical Trial Application process

On March 2024, the FDA released its latest publication titled “Collaborative Efforts: Harnessing Artificial Intelligence in Medical Products,” shedding light on the concerted actions undertaken by CBER, CDER, CDRH, and OCP in navigating the landscape of AI integration within the medical product realm. This comprehensive document delineates strategic focal points essential for advancing the application of AI throughout the entire lifecycle of medical products.

Japan’s PMDA Remote Inspections

The PMDA clarifies its requirements for conducting remote compliance inspections related to drugs and regenerative medical products.