Regulatory Oversight and Compliance

Janssen Seeks European Approval of Extended Indication for Rybrevant

October 11, 2023

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

Lilly Receives Complete Response Letter from FDA for Lebrikizimab

October 09, 2023

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

FDA Establishes Pilot Program to Accelerate Rare Disease Therapy Development

October 05, 2023

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

FDA Gets Its Arms Around Advanced Therapy Medicinal Products Early

October 02, 2023

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

Control Strategy: A Feedback-Feedforward ‘Controls Hub’ for Risk, Knowledge, and Product Lifecycle Management

September 29, 2023

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.

MHRA Publishes New Guidance on International Regulatory Recognition Route

September 28, 2023

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

EC Approves Polpharma Biologics’ MS-Treating Biosimilar

September 28, 2023

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

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.