Biomedical Engineering Reference
In-Depth Information
Filed NDA
Multidisciplinary review
expert panel
Primary
Review
Supervisers of the individual
members of the initial
review
panel
Secondary
Review
FDA Division
Director
Review and recommendation
(for approval or otherwise)
Figure 4.12
The CDER review process for a typical NDA. In addition to the review stages described, the FDA
may also consult with a technical advisory committee. The members of the advisory committee are not rou-
tinely involved in IND or NDA assessment. The FDA is not obliged to follow any advice given by the advisory
committee, but it generally does so
A similar general approach is taken by the CBER with regard to drugs being developed un-
der their auspices. The CBER 'licensing process' for a new drug consists of three phases: the
IND phase (already discussed), the pre-marketing approval phase (licensure phase) and the post-
marketing surveillance phase. The pre-marketing approval phase (i.e. clinical trial phase) aims to
generate data that prove the potency, purity and safety of the product. Upon completion of clinical
trials, the sponsor collates the data generated and submits it to the FDA in the form of a BLA,
which must provide a comprehensive description of both the product and product manufacture
(including methods of QC analysis, product stability data, labelling data and, of course, safety and
effi cacy data).
A small number of biotechnology products are classifi ed as medical devices and, hence, are regu-
lated by the Center for Devices and Radiological Health (CDRH). The fi rst approved biotech prod-
uct to come under the auspices of the CDRH was OP-1 implant. Marketed by Stryker Biotech, OP-1
implant is a sterile powder composed of recombinant human oestrogenic protein-1 (OP-1) along with
bovine collagen. It is used to treat fractured bones that fail to heal. The product is mixed with sterile
saline immediately before application, and entails surgical insertion of the paste into the fracture.
4.14.4 European regulations
The overall philosophy behind granting a marketing authorization for a new drug is broadly simi-
lar in the USA and Europe. There are, however, major differences in the systems by which these
philosophies are implemented in the two regions.
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