Regulatory Developments

Posted By Linda Brown
Found In Microsite: AAPS News Magazine
Notices of an FDA pilot program, government-owned inventions available for licensing, and guidance for industry.    FDA announces a pilot program for drug/biologics sponsors and applicants to discuss model-informed drug development (MIDD) with FDA. ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
If you or your AAPS Community would like to comment on the following guidances, please contact AAPS’ Director of Public Outreach Stacey May . FDA Guidance Pediatric Studies during Drug Development This draft guidance addresses the timing of ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
Notices of guidance for industry and continuation of the Regulatory Project Management Site Tours and Regulatory Interaction Program.  Table of Contents Regulatory Developments April 2018 Notices The FDA Center for Drug Evaluation and Research (CDER) ...
Posted By Tricia McCarter
Found In Microsite: AAPS News Magazine
Notices of patent infringement, an oncology listening session, a new antimicrobial drugs website, a workshop on safety assessment, FDA guidance, and more.  Notices FDA announces the issuance of a priority review voucher to the sponsor of a rare pediatric ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
Notices of patent infringement, an oncology listening session, a new antimicrobial drugs website, a workshop on safety assessment, FDA guidance, and more.  Notices FDA announces that an applicant for a proposed biosimilar product has notified the agency ...