Topic

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Articles

The IDAP pilot scheme is designed to accelerate access to innovative medical devices and is a pioneering legislative proposal in the UK medical device space.

Improving Patient Access Through the UK IDAP Scheme

Feliza Mirasol is the science editor for 

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.



New FDA Draft Guidance Made Available for Materials Used in Manufacturing CGTs and Tissue-Engineered Therapeutics

The report covers the major achievements of the office during 2023, including notable drug approvals, publications, guidances, workshops, webinars, and meetings.

CDER Releases Office of New Drugs 2023 Annual Report

In the new draft guidance, FDA provides recommendations on cell safety testing of human-sourced allogeneic cells for sponsor companies.

New FDA Draft Guidance Issued for Sponsors of Allogeneic Cell-Based Medical Products.

The agreement, which will allow participants to share confidential information on medical and medicinal products, builds on the cooperation fostered between the two regulatory authorities during the COVID-19 pandemic.

Confidentially Agreement Signed Between European Union and Republic of Korea Regulatory Bodies

The majority of PMCs/PMRs are proceeding according to schedule.

FDA Reports on Status of Postmarketing Requirements and Postmarketing Commitments

Felicity Thomas is Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

FDA has granted approval for the use of Novartis’ radioligand therapy, Lutathera, to treat pediatric patients with gastroenteropancreatic neuroendocrine tumors.

Novartis’ Radioligand Therapy Gains FDA Nod for Pediatric Patients 

Michele Duggan is senior manager, Regulatory Affairs, at Thermo Fisher Scientific.

Regulations for mRNA products are evolving as the market for mRNA expands. 

Navigating an Uncertain Regulatory Environment for mRNA-based Products

A panel of experts went over new regulatory requirements for contamination control and gave guidance on implementing a contamination control strategy in cell and gene therapy facilities at INTERPHEX 2024.

INTERPHEX 2024: Implementing Contamination Control Strategies in Cell and Gene Therapy Facilities 

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Videos

Susan Schniepp, distinguished fellow, Regulatory Compliance Associates, and co-chair of board of directors, Parenteral Drug Association, demonstrates QMS impact on quality maturity at INTERPHEX.

Quality Systems