In comments to the US Food and Drug Administration (FDA), pharmaceutical industry groups called for revisions to the International Council for Harmonisation’s (ICH) M11 guidance establishing a harmonized template for clinical trial protocols. The groups said the document should be revised to broaden the definition of a protocol, recommended that the use of estimands be justified in the protocol and include more examples of real-world data (RWD).   The guidance also inc...

Regulators from the United Kingdom and Japan are promoting the use of platform trials to evaluate second-generation COVID-19 vaccines as the pool of unvaccinated patients for testing new vaccines grows increasingly smaller. They also proposed the creation of a working group to build consensus on the design of master protocols, particularly in the context of health emergencies.   These pronouncements emerged from a 24 June virtual workshop on aligning approaches for dev...

Top officials from the US Food and Drug Administration (FDA) exhort the benefits of master protocols and hope the momentum of using these protocols continues in the post-COVID-19 era. Officials also say the pandemic has not dampened the enthusiasm for gene therapy development as the agency continues to receive a healthy number of investigational new drug applications (INDs) for these therapies.   These were some of the learnings imparted by agency officials in discussi...

A new guidance from the US Food and Drug Administration (FDA) addresses how master protocols can be used in developing drugs to treat or prevent COVID-19.   “To meet the urgent demand for effective therapies, FDA has worked with clinical trial experts to rapidly advance best practices in the design and execution of clinical trials,” said acting FDA Commissioner Janet Woodcock in announcing the new guidance. “Master protocols that are well designed and executed can acce...

This article discusses the application of master files to the new dietary ingredient notification process to protect intellectual property of ingredient manufacturers and incentivize submission of NDI notifications. The author describes an NDI master file model, based on the US drug master file, as a proposal for consideration by the US Food and Drug Administration.   Introduction Innovation grows industries, and it is no different for the dietary supplement industry...

In an article published Thursday in the New England Journal of Medicine , two top officials from the US Food and Drug Administration (FDA) say that "master protocols" for studies involving multiple drugs or multiple diseases (or both) simultaneously are needed to efficiently generate evidence for precision medicines. "The standard approach to generating this evidence—a series of clinical trials, each investigating one or two interventions in a single disease—has become ...

The European Medicines Agency (EMA) on Wednesday released for consultation a new draft guideline to assist sponsors and investigators looking to comply with the requirements of the clinical trial master file (TMF), which includes documentation to allow monitoring by the sponsor and member state inspections. "This guideline aims to collate and explain the requirements for the TMF as covered in the Regulation [(EU) No 536/2014] and ICH-GCP E6 to assist organisations in ma...

The US Food and Drug Administration (FDA) is giving drugmakers an additional year before requiring master files to be submitted in electronic common technical document (eCTD) format. In a revised guidance released Friday, FDA says it is delaying the requirement for drug master files (DMF) and biological product files (BPF) to be submitted in eCTD format until 5 May 2018. Other documents, such as new drug applications (NDAs), abbreviated new drug applications (ANDAs) and...

This article describes ongoing procedures and initiatives for 'worksharing' in the evaluation of active substance dossiers by regulatory authorities around the world. Introduction An Active Substance or Drug Master File (ASMF/DMF) can be used to describe the chemistry, manufacture and controls for an active substance. It is typically divided into an applicant's or open part and a restricted or closed part. The applicant's part is provided to the Marketing Authorizatio...

The European Medicines Agency (EMA) has released a draft Guideline on epidemiological data on blood transmissible infections intended to provide clarification on the data requirements for plasma-derived products. Background In the EU, companies must submit scientific data for blood- or plasma-derived medicinal products using the plasma master file (PMF) certification procedure. The requirement for PMF certification was established in Directive 2003/63/EC , which ...

There is mounting evidence that pursuing a professional or graduate certificate may be a very savvy career investment. The popularity of certificates is on the rise. According to a 2012 study from the Georgetown University Center on Education and the Workforce, certificates are the fastest growing postsecondary credential, and second only to bachelor’s degrees in the number earned each year. About 10% of regulatory professionals now have postgraduate certifica...

The regulatory landscape has evolved dramatically in the last few decades. Today’s regulatory professionals perform key functions in their organizations, including ensuring compliance with regulations and facilitating the development and commercialization of new products. These professionals must be equipped to address the increased complexity of the modern regulatory landscape. One important way to prepare is through graduate studies. Graduate education in regulatory pla...