Regulatory Developments

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 FDA Guidance Pediatric Studies during Drug Development This draft guidance addresses the timing of ...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.  Table of Contents Regulatory Developments March 2018 Notices FDA announces the issuance of a ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
Notices FDA announces that an applicant for a proposed biosimilar product has notified the agency that a patent infringement action has been filed in connection with the applicant’s biologics license application. The complaint, AbbVie Inc. v. Boehringer ...
Posted By Linda Brown
Found In Microsite: AAPS News Magazine
Table of Contents Regulatory Developments January 2018 Notices The Food and Drug Administration (FDA) announces Office of Management and Budget approval of 11 information collection requests. The collections address color additive petition and food ...