Regulatory Oversight and Compliance

CDER Announces Emerging Drug Safety Technology Meeting Program

June 10, 2024

The new meeting program will create a dialogue around AI and be administered through CDER’s Emerging Drug Safety Technology Program.

Drug Shortage Reports Emphasize Continuing Problems

June 10, 2024

USP and FDA publish reports detailing drug shortage numbers and challenges through 2023.

Using RWD in Non-Interventional Studies

June 05, 2024

EMA is promoting the use of RWD in decision-making and has started a public consultation to review its draft recommendations.

CGT Catapult and CATTI Establish Shared Training Standards for Advanced Therapies

June 04, 2024

CGT Catapult and CATTI aim to standardize advanced therapy manufacturing with new aligned training standards.

Sanofi Gets Priority Review Status for sBLA Seeking Approval of Sarclisa in Combination Therapy for Multiple Myeloma

May 30, 2024

FDA granted priority review to Sanofi's sBLA for Sarclisa in combination with VRd in treating transplant-ineligible patients who are newly diagnosed with multiple myeloma.

FDA Approves Interchangeable Biosimilar to Soliris

May 30, 2024

Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

Pharmaceutical Compounding Calculations in a Workplace Environment

May 29, 2024

An ordered process describing calculations activities for compounded dosage forms is described.

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

May 28, 2024

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

EMA Suspends Hydroxyprogesterone Caproate Medicines in Europe

May 20, 2024

After a review, the agency concluded there was a possible risk of cancer to those exposed to 17-hydroxyprogesterone caproate in the womb.

Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing

May 16, 2024

Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.