USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
sive information about pending applications is released in the form of briefing papers and presentations used at FDA Advisory Committee meetings. The FDA does not reveal the existence of pending INDs or IDEs unless the sponsor has publicly acknowledged the filings. Third parties may submit requests for informa- tion under the Freedom of Information Act (FOIA); however, there are a variety of exceptions from disclosure, as well as a major FDA backlog of requests. Most importantly, the FDA has an obli- gation under the FOIA to refrain from publica- tion of trade secrets or confidential commercial or financial information. Sponsors/applicants are afforded an opportunity to review potential releases of information and request confidential treatment under those FOIA exceptions. 4. Regulatory Reliance and Fast Track Registration Routes 4.1 Fast Track Registration Routes There is an array of expedited programmes for the registration of medicines and medical devic- es. These programmes include: • fast track designation for drug and biologi- cal products for serious conditions where said products demonstrate the potential to address an unmet medical need; • designation as a breakthrough therapy in the case of drugs for serious conditions where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on a clinically significant end- point over available therapies, or in the case of the breakthrough devices programme that applies to designated devices that provide for more effective treatment or diagnosis of life-
threatening or irreversibly debilitating human disease or conditions, among other criteria; • accelerated approval for products that treat a serious condition, provide a meaningful advantage over available therapies, and dem- onstrate a significant impact on a surrogate endpoint that is reasonable likely to predict clinical benefit or on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality – although the clinical effectiveness of such products must be con- firmed in post-market studies; and • priority review for drugs that treat a serious condition and, if approved, would provide a significant improvement in safety or effective- ness (or if the FDA is presented with a priority review voucher). Each of the above-mentioned programmes provides various benefits that may accelerate approval, ranging from additional agency input to rapid review. 4.2 Regulatory Reliance If a company has already obtained authorisa- tions (whether product-related or establishment- related) from internationally recognised jurisdic- tions, the FDA does not expedite the issuance of its own authorisations. However, there are fre- quent interactions between the FDA and other jurisdictions – in particular, Canada, the UK, and the EU - concerning issues such as establish- ment inspection priorities and product safety.
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