Changes and Challenges for CDER

The Center for Drug Evaluation and Research is adopting new approaches to how it oversees the development and approval of new drugs and how it ensures the safe use of prescription drugs by the public.

Articles in this issue

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Report on the Industry Blend Uniformity Practices Survey

Interphex Presents a Wide Array of Packaging Innovations

Changes and Challenges for CDER

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July 25th 2025

EMA Approves Lower GWP Alternative for Inhalation Medicine

Susan Haigney

The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava Aerosphere that will have a 1000-fold reduction in global warming potential compared to the current propellant.

June 25th 2024

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

July 23rd 2025

ICH Q12 and Post-Approval Changes–Less than Satisfactory State of Affairs

Siegfried Schmitt

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

July 22nd 2025

Bristol Myers Squibb Application for Psoriatic Arthritis Drug Accepted for Review in Four Regions

Patrick Lavery

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

July 21st 2025

FDA Appoints New CDER Director, George Tidmarsh

Susan Haigney

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.

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July 25th 2025

EMA Approves Lower GWP Alternative for Inhalation Medicine

Susan Haigney

The agency has given a positive recommendation for a change in the gas propellant in Trixeo Aerosphere and Riltrava Aerosphere that will have a 1000-fold reduction in global warming potential compared to the current propellant.

June 25th 2024

Drug Solutions Podcast: Growth and Advancements in Fill/Finish

Felicity Thomas

In this episode, Hanns-Christian Mahler from ten23 Health chats about the advances in fill/finish.

July 23rd 2025

ICH Q12 and Post-Approval Changes–Less than Satisfactory State of Affairs

Siegfried Schmitt

Speedier implementation of the Post-Approval Change Management Protocol is essential for it to have a positive effect on supply security, says Siegfried Schmitt, PhD, vice president, Technical at Parexel.

May 28th 2024

Drug Solutions Podcast: All About Data: Looking at the EHDS in More Detail

Felicity Thomas

In this episode, Alexander Natz from EUCOPE chats about the European Health Data Space.

July 22nd 2025

Bristol Myers Squibb Application for Psoriatic Arthritis Drug Accepted for Review in Four Regions

Patrick Lavery

Sotyktu (deucravacitinib) has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of March 6, 2026.

July 21st 2025

FDA Appoints New CDER Director, George Tidmarsh

Susan Haigney

George Francis Tidmarsh, MD, PhD, founding co-director of Stanford’s Master of Translational Research and Applied Medicine program, has been appointed as the new director of the Center for Drug Evaluation and Research.