Regulatory Oversight

EC has confirmed that the entry into application of the Clinical Trials Regulation and, as such, the go-live date for the Clinical Trials Information System (CTIS) will be Jan. 31, 2022.

Bristol Myers Squibb has been granted approval by the European Commission for Opdivo (nivolumab) as an adjuvant treatment

EMA’s CHMP has approved the increased manufacturing capacity and supply of Moderna’s COVID-19 vaccine active substance in its US manufacturing site.

A robust selection of which product(s) and equipment to validate for cleaning is the cornerstone of a successful cleaning validation program. A strategy for selection of products and equipment for cleaning validation is presented.

An effective data structure and simple communication between production, logistics, and sales are essential for delivering this level of accountability, traceability, and security.

Pharma and biotech supply chain companies are working together to help facilitate the transition of the pharma industry to net zero emissions compliance.

Full approval of COVID-19 vaccines may increase public confidence, but better coordination in development and review is needed.

Experts Susan J. Schniepp, distinguished fellow for Regulatory Compliance Associates, and Steven J. Lynn, executive vice-president, Pharmaceuticals for Regulatory Compliance Associates, provide answers to frequently asked regulatory questions about advanced therapy medicinal products.

The agency’s leading cancer expert lashed out at the alarmists and urged continued support for the early access process.

Sponsors should consider best practices for maintaining data generated during sample analysis and instrument maintenance.

New challenges arise in extractable and leachable studies for cell and gene therapy products.

Emergent BioSolutions is being allowed to restart manufacturing operations for the J&J COVID-19 vaccine at its Bayview, Baltimore, Md., facility.

FDA officials discuss resuming normal facility inspection operations, both domestic and foreign.

The Yale School of Public Health’s regulatory sciences program expansion builds on the current regulatory affairs track program, which focuses on the administrative, policy, and legal aspects of product regulation.

The approved changes to the API manufacturing plant in Leiden, the Netherlands will enable an increase in API capacity.

The rise of COVID variants has made public health officials anxious to expand immunity more widely and quickly in areas with low vaccination rates, and experts hope that full approval of existing and new vaccines will increase public confidence in their value.

An updated version of legislation to modernize clinical research policies and FDA expedited approval pathways is circulating on Capitol Hill.

Despite some improved understanding of adapted processes in light of the pandemic, information is still not filtered throughout the qualified persons community fully and more work by authorities and associations is required to improve communications.

The draft revisions of Annex 1 are driven by a quality risk management approach and will provide more clarity and detail for manufacturers.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

The Lasair Pro Airborne Particle Counter from Particle Measuring Systems is designed to meet data Integrity and regulatory requirements.

With COVID-19 vaccine facilities receiving recent citations, it is evident that failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.

EMA's recent positive opinion for a recombinant vaccine for rabbits developed using Algenex’s proprietary and patent protected Baculovirus vector-mediated expression platform, CrisBio, should push the full commercialization of the platform forward.

The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

As a safety measure, supervisory authorities in the European Union have recommended not releasing batches of Janssen’s COVID-19 vaccine with API manufactured at Emergent BioSolutions’ Maryland facility.

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.