Regulatory Oversight

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).

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

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

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.

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

Iopofosine provides targeted delivery of idodine-131 directly to cancer cells.

Kelley Burridge, PhD, Product Quality Team Leader, OBP, OPQ, CDER, U.S. FDA, discusses the barriers to the development of continuous manufacturing processes after implementing ICH Q13.

The safety profile of erdafitinib observed in THOR was consistent with the previously reported safety profile of erdafitinib in metastatic urothelial carcinoma (mUC).

Rentschler Biopharma’s ATMP business can now offer its full range of services for the clinical supply of AAV, including bioprocess and analytical development through to cGMP manufacturing at the Stevenage facility in the UK.

The results showed that PathoQuest’s proprietary NGS approach is an effective, more robust replacement to in vivo adventitious virus testing of cell substrates used in the production of biologics, like monoclonal antibodies, vaccines, cell, and gene therapies.

Further expansions of the pharmaceutical development and manufacturing services of ten23 are happening at the BASE and VIVA facilities to continue to support complex sterile product development, testing, and manufacturing.

FDA is anticipating how AI may advance manufacturing and improve supply chain security.

Recent research and perspectives shed light on an opportunity to better connect risk and knowledge through improved integration of systems.

The ACT EU initiative aims to develop the European Union further as a competitive centre for innovative clinical research.

Audits and inspections both assure that requirements have been fulfilled and whether documented proof is available, says Siegfried Schmitt, vice president, Technical at Parexel.

The updated vaccine will be ready to ship following a positive European Commission review.

The patent grants Alterity 20 years of exclusivity over a new class of iron chaperone drug candidates.

The assessment aims to determine whether valproate use in men could lead to neurodevelopmental disorders in their children.

The indication for Pombiliti is a long-term enzyme replacement therapy (ERT) used in combination with miglustat for adults with late-onset Pompe disease (LOPD).

The guidance can help both applicants and manufacturers limit the mutagenic and carcinogenic potential of NDSRIs.

Current good manufacturing practices for oral solid dosage forms protect the product from contamination and potential errors.

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

An intelligent drug development paradigm can enable small pharma to implement an effective early drug development approach.

The framework is now expanded beyond COVID-19 vaccines and treatments.

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.