FDA – Page 9 – Policy & Medicine

Eli Lilly is the Recipient of the First OPDP Untitled Letter of 2022

FDA Issues Two Draft Guidance Documents on Real-World Data

Becerra Reinstates FDA Rulemaking Authority

FDA Revises COVID-19 ANDA Guidance

CME/CNE/CPE Medical Education Program Helps Physicians Integrate the FDA Mycophenolate Safety Standards to Prevent Potential Birth Defects

FDA Updates Final Guidance on Biosimilar Development

CMS Wants to Repeal MCIT Final Rule

FDA Issues Draft Guidance on RWD Sourced from EHRs and Medical Claims Data

FDA REMS Pain Management and Opioid Therapy: Persistent Knowledge Gaps Among Primary Care Providers Rockpointe Program Shows Need for More Healthcare Provider Education

FDA Requests Input on How to Handle Post-Approval Regulation of PANDAs