USA Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho, Arnold & Porter
2.6 Databases Containing Personal or Sensitive Data A database containing personal or sensitive data may be subject both to contractual and statutory protections obliging maintenance of data secu- rity and privacy. 3. Marketing Authorisations for Pharmaceuticals or Medical Devices 3.1 Product Classification: Pharmaceuticals or Medical Devices Such determinations are typically made by assessing the primary mode of action of the product and whether it works by chemical, biological, mechanical or other means. If the product combines chemical, biological and/or mechanical modalities, a Request for Designa- tion may be submitted to determine how the FDA believes the product should be regulated, under definitional and pathway provisions. 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products Drug products are approved via New Drug Appli- cations (NDAs). Additional indications, dosage forms, etc, may be added via NDA supplements. Biological products are approved in a virtually identical process via Biologics Licence Applica- tions (BLAs). The standard for approval is “sub- stantial evidence” of safety and effectiveness (technically, “safety, purity and potency” for bio - logics), resulting from at least one – and typically several – adequate and well-controlled clinical studies. The typical drug or biologic review pro- cess takes ten months after initial acceptance for filing (a 60-day period); however, a priority review of six months is given to certain drugs and biologics intended to treat serious or life- threatening conditions.
Substantial user fees – USD4,310,002 in fiscal year 2025 for an NDA or BLA containing clini- cal data – are required to facilitate a review of applications. 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices There is no mandatory re-authorisation process for approved products. However, the FD&C Act and FDA regulations include processes for the withdrawal or revocation of an approval based upon a significant safety or effectiveness issue or non-compliance with approval requirements. These processes can be expedited in certain scenarios, such as an applicant’s failure to confirm the efficacy of an accelerated approval product in a post-market study, or where there is an imminent hazard. In general, a market- ing authorisation may not be revoked merely because the product has not been placed on the market – although a failure to market an orphan drug could result in a loss of orphan exclusivity. 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices As noted in 3.2 Granting a Marketing Authorisa- tion for Biologic Medicinal Products , the path- ways for approval of drugs consist of: • the submission of an NDA (including a 505(b) (2) NDA relying on data for which the appli- cant does not have a right of reference); and • the Abbreviated New Drug Application (ANDA) for generic products, which demon- strates equivalence to a reference listed drug. A biologic is licensed via the submission of a BLA; however, that process is largely the equiva- lent of an NDA submission. A biosimilar appli- cation demonstrates that, based on the totality
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