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Pharmaceuticals: Some General Aspects
Published in Peter Grunwald, Pharmaceutical Biocatalysis, 2019
According to more recent developments, the FDA offers an Expedited Program for speeding up the availability of drugs that treat serious diseases: Fast track (the aim is to facilitate the development, and expedite the review of drugs to treat serious conditions, filling an unmet medical need), breakthrough therapy (substantial improvement over available therapy), priority review (FDA’s goal is to take action on an application within 6 months), and accelerated approval (allows drugs to be approved based on a surrogate endpoint) are the 4 ways applied singly or in conjunction in which the FDA cooperates with the industry (see Table 1.1) in developing drugs (FDA, 2018; 2018a). This resulted in an increase of the speed at which new drugs are and have been developed and reviewed, and is expressed by the fact that 78% and 87% of drug applications were approved by the FDA in the first review cycle in 2014 and 2015, respectively, compared with just 58% between 2008 and 2012 (Tworkoski, 2016).
Current Immune Aspects of Biologics and Nanodrugs: An Overview
Published in Raj Bawa, János Szebeni, Thomas J. Webster, Gerald F. Audette, Immune Aspects of Biopharmaceuticals and Nanomedicines, 2019
I am not a fan of the various accelerated approaches currently underway and on the rise at global regulatory agencies, primarily at the FDA, EMA, and PMDA. For serious or life-threatening disease, the FDA can approve drugs through its accelerated approval review track based on surrogate end-points (rather than hard clinical end-points) that are “reasonably likely to predict clinical benefit.” This pathway was designed in the early 1990s to speed drug development. Various accelerated approaches include breakthrough therapy designation, accelerated approval, and conditional marketing authorization—collectively referred to as “facilitated regulated pathways” (FRPs). A greater uncertainty is introduced into the regulatory approval process via FRPs. This could translate into unwanted immunogenicity.
Regulatory Affairs
Published in John M. Centanni, Michael J. Roy, Biotechnology Operations, 2016
John M. Centanni, Michael J. Roy
Accelerated Approval: Drugs or biologicals indicated for the prevention or cure of serious or life-threatening diseases are eligible for a program known as Accelerated Approval. Under this regulation, the FDA may approve such products on the basis of a surrogate or clinical endpoints if these are likely to predict clinical benefit. Clinical studies are still required, but they may not require the stringent and long clinical processes for other drugs. There are restrictions on the approval, however, and sponsors carefully choose this route in special projects.
Biologics regulation, second-to-market competition, and the use of blockchain technology: an opportunity for the FDA to support responsible biotechnology innovation
Published in Journal of Responsible Innovation, 2020
In 2012, the U.S. Congress passed the Food and Drug Administration Innovations Act (FDASIA). Under Section 901 of the FDASIA (which amends the Federal Food, Drug, and Cosmetics Act), the FDA is authorized to base Accelerated Approval Review for drugs that address serious conditions that fill an unmet medical need on whether the drug has an effect on a surrogate or an intermediate clinical endpoint or marker. The Breakthrough Therapy Review, also implemented under the FDASIA, is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and provides preliminary critical evidence which indicates that the drug may demonstrate substantial improvement over an available therapy on a clinically significant endpoint(s).