Regulatory Oversight and Compliance

FDA Inspections Face Overhaul

September 28, 2023

The agency will be reorganizing field force and compliance functions.

FDA Releases Guidance on Using Remote Oversight Tools for Drug Approval

September 26, 2023

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

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.

EC Approves Fixed-Dose Oral Combination Treatment for AML

September 20, 2023

Otsuka Pharmaceutical Europe and Astex Pharmaceuticals have announced the approval of INAQOVI by the European Commission.

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.