Regulatory Oversight and Compliance

This approval builds on a previous approval of the combination therapy for patients with BRAF V600E- or V600K-mutant unresectable or metastatic melanoma.

Sterling is known as a global contract development and manufacturing organization, and their network spreads to a manufacturing site in Cramlington, United Kingdom, a recently GMP-licensed dedicated bioconjugation facility in Deeside, and a 111-acre site in Ringaskiddy, Ireland.

The recommended medicines include treatments for Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis, menopause symptoms, and diagnostic medicines for characterizing lesions.

The agency recommended conditional marketing authorization for Elrexfio (elranatamab) as a monotherapy for adult patients with relapsed and refractory multiple myeloma.

The 65,000-square-foot facility is designed with the capacity and capability to help scale the next generation of CGTs for human trials and beyond.

The draft guidance document discusses quality considerations for topical ophthalmic drug products.

The new Digital Health Advisory Committee will advise the agency on issues related to technologies such as AI, virtual reality, and machine learning.

Further, the construction of Gritgen’s GMP facility strictly adheres to the global current GMP (CGMP) standards and complies with the regulatory guidelines of authoritative agencies including the National Medical Products Administration (NMPA), FDA, and the European Medicines Agency (EMA).

Janssen has requested an extension to the indication application of its fully-human, bispecific antibody treatment, Rybrevant (amivantamab).

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

A control strategy can function as a powerful “hub” to gain a comprehensive understanding of the consolidated set of controls that are necessary to ensure consistent delivery of quality product.

The new framework will position the UK as an attractive prospect for new medicine manufacturers.

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

The agency will be reorganizing field force and compliance functions.

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

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.

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

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

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.

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.

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

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

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