FDA – Page 12 – Policy & Medicine

Review of 2020 FDA Enforcement Activities

FDA Releases Draft Guidance on IND Submissions for Individualized Antisense Oligonucleotide Drug Products

Industry Seeks Clarity on Interchangeability for BsUFA III

FDA Releases Final Guidance Under GDUFA II

FDA Issues Draft Guidance on Proprietary Names

OPDP Sends Six Warning and Untitled Letters in 2020 – Final Letter Sent to Azurity Pharmaceuticals

FDA Finalizes Guidance Regarding Complex Products Meetings

FDA Releases Draft Question and Answers Guidance on Interchangeable Products

CDRH Releases List of FY 2021 Priority Guidance Documents

OPDP Director Tom Abrams Retires