Regulatory Authority Actions

The new advisory committee will provide the agency with technical and scientific advice and recommendations on potential treatments for genetic metabolic diseases.

Sanofi has issued a statement expressing its disappointment with FTC’s decision to block an exclusive licensing agreement with Maze Therapeutics for a rare disease drug candidate.

Biologics have specific quality considerations that make fast tracking these drugs more difficult.

Exagamglogene autotemcel seen as synechdoche.

Adzynma provides a replacement for low levels of the ADAMTS13 enzyme in patients with congenital thrombotic thrombocytopenic purpura.

Electronic product information for selected human medicines that have been harmonized across the European Union have been published for the first time.

The document includes recommendations for the reporting and implementation of changes to container closure system components.

This is the second biologic approved to treat HS, a painful and reoccurring skin disease.

The guidance describes the agency’s procedures for performing remote interactive evaluations at drug manufacturing and bioresearch monitoring facilities.

PENBRAYA combines components from two meningococcal vaccines, Trumenba and Nimenrix.

The agency’s solidarity mechanism allows Member States to support each other when there is a shortage of a critical medicines.

The final guidance document was issued to assist bio/pharma companies in the clinical development and licensure of COVID-19 vaccines.

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

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

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

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

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.

What impact will EMA’s decision to phase out COVID-19 regulatory flexibilities have on the pharma industry?

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

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.