Regulatory Authority Actions

The European Commission Approves Severe Alopecia Areata Treatment

September 21, 2023

Pfizer reports ritlecitinib is the first and only treatment for alopecia areata to selectively inhibit Janus kinase 3, and to treat patients as young as 12.

Continuous Manufacturing is Here to Stay (PDA/FDA Joint Regulatory Conference 2023)

September 20, 2023

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the importance of continuous manufacturing for the future.

ICH Q9 R1 Hits Major Milestones for the Pharmaceutical Industry

September 20, 2023

As for the topic of subjectivity, Viehmann said how high levels of subjectivity in risk assessments and in QRM are problematic and are not aligned with the 1st QRM principle of Q9.

Highlights of ICH Q13 Session (PDA/FDA Joint Regulatory Conference 2023)

September 20, 2023

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the highlights of her ICH Q13 session that she wants others to be aware of.

Staying Compliant in 2023

September 20, 2023

Leaders at CDER and CBER give update on organizational changes at FDA.

EMA Prepares for Regulation on Health Technology Assessment

September 19, 2023

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

FDA Approves Treatment for Myelofibrosis Patients with Anemia

September 19, 2023

Anemia, experienced by most myelofibrosis patients, has caused over 30% of patients to discontinue their treatment.

EMA Grants Priority Medicine Status to Cellectar’s Waldenstrom Macroglobulinemia Treatment

September 19, 2023

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

Barriers to the Development of Continuous Manufacturing and ICH Q13 (PDA/FDA Joint Regulatory Conference 2023)

September 18, 2023

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

FDA Issues Guidance on Biosimilar Labeling

September 18, 2023

The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.