France to create clinical trial fast track for cell and gene therapies

France’s Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) are to create a fast track for applications to run clinical trials of cell and gene therapies. The proposed regulatory process will reduce the time it takes sponsors to receive authorisation to start clinical trials to 110 days. Read more “France to create clinical trial fast track for cell and gene therapies”

FDA releases draft guidance on meta-analysis of randomised controlled clinical trials

The Food and Drug Administration (FDA) has released draft guidance on meta-analysis of randomised controlled clinical trials to evaluate the safety of human medicines or biological products. The FDA stated that conducting meta-analysis to evaluate safety questions presents a unique opportunity to detect and quantify the risk of a safety event and may help provide a more precise estimate of the risk of uncommon serious adverse events by combining information from multiple trials. Read more “FDA releases draft guidance on meta-analysis of randomised controlled clinical trials”

FDA releases draft guidance on master protocols – efficient clinical trial design strategies to expedite development of cancer drugs and biologics

The Food and Drug Administration (FDA) has released a 21-page draft guidance on master protocols, which aims to provide recommendations to sponsors of drugs or biologics for the treatment of cancer, regarding the design and conduct of clinical trials intended to simultaneously evaluate more than one investigational drug and/or more than one cancer type within the same overall trial structure (master protocols) in adult and paediatric cancers. Read more “FDA releases draft guidance on master protocols – efficient clinical trial design strategies to expedite development of cancer drugs and biologics”

UK reassures industry that the aim is to adopt the EU Clinical Trial Regulation

The United Kingdom (UK) has committed to adopting the European Union (EU) Clinical Trial Regulation despite Brexit. In the House of Lords, a government representative has made a promise to prevent a potential rebellion that would have pushed for a legislative guarantee that the UK will adopt the regulation. Read more “UK reassures industry that the aim is to adopt the EU Clinical Trial Regulation”

FDA finalises guidance regarding sponsor-FDA agreements on trials

The United States (US) Food and Drug Administration (FDA) has finalised guidance on the special protocol assessment (SPA), which is the process by which sponsors of pharmaceutical or biologic applications can meet with the FDA to discuss the design and size of certain clinical or animal studies to determine if they can adequately support marketing approval. Read more “FDA finalises guidance regarding sponsor-FDA agreements on trials”

FDA drafts guidance on scientific and ethical considerations in including pregnant women in clinical trials

The Food and Drug Administration (FDA) have released guidance which provides recommendations about how and when to include pregnant women in drug development clinical trials for drugs and therapeutic biological products. The guidance aims to support an informed and balanced approach to gathering data on the use of drugs and biological products during pregnancy through judicious inclusion of pregnant women in clinical trials and careful attention to potential fetal risk. Read more “FDA drafts guidance on scientific and ethical considerations in including pregnant women in clinical trials”

TGA Australia publishes updated guidance on conducting clinical trials

The Therapeutic Goods Administration (TGA) Australia has released updated guidance on running clinical trials. The handbook provides guidance on the legislative, regulatory and good clinical practice (GCP) requirements when conducting clinical trials in Australia using ‘unapproved’ therapeutic goods. Read more “TGA Australia publishes updated guidance on conducting clinical trials”

FDA finalises rule which requires medical device trials conducted outside the US to conform with GCP standards

On February 21st 2018, the United States (US) Food and Drug Administration (FDA) finalised a rule which requires medical device clinical investigations that are conducted outside the US to flexibly conform to good clinical practice (GCP) standards. Sponsors and applicants are required to provide statements and information regarding how their clinical investigations conform to GCP standards. Read more “FDA finalises rule which requires medical device trials conducted outside the US to conform with GCP standards”