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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).
Commissioning, Qualification, and Validation
Published in Terry Jacobs, Andrew A. Signore, Good Design Practices for GMP Pharmaceutical Facilities, 2016
On July 9, 2012, the FDA’s Safety and Innovation Act (FDASIA) was signed into law. One of the goals of FDASIA is to promote innovation to speed patient access to new products. Under FDASIA, new drugs may be given special designations to expedite development and agency review. This includes granting fast-track, breakthrough therapy, accelerated approval, and priority review designations. The goal of these designations is to expedite the development and review of new drugs with preliminary evidence indicating the drug may offer a substantial improvement over other available treatments for serious or life-threatening diseases, and especially for those that offer treatments where no other therapies are available. The ultimate goal is to bring these therapies to patients as soon as it can be concluded that the benefits justify the risks [15, 16]. This has led to earlier patient access to new, often lifesaving therapies.
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 1992, under the Prescription Drug User Fee Amendments (PDUFA), the FDA created a two-tiered system of drug review: the Standard Review and Priority Review. Under a Priority Review designation, the FDA focuses its overall attention and resources on the evaluation of applications that, if approved by the agency, are expected to result in significant improvements in the safety and effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to Standard Review applications. Under a Priority Review application, the FDA’s goal is to take action on an application within 6 months, as compared to 10 months under a Standard Review. Also under the PDUFA, the FDA instituted the Accelerated Approval regulations, which allows drugs for serious conditions that filled an unmet medical need to be more rapidly evaluated based on a surrogate endpoint.