Abbott Laboratories 2015 Annual Report Download - page 71

FINANCIAL REVIEW
69
ABBOTT 2015 ANNUAL REPORT
before the manufacturer can ax a CE mark to the product to
show compliance with the Directive. Other products only require
a self-certification process.
In the Vascular segment, the research and development process
begins with research on a specific technology that is evaluated for
feasibility and commercial viability. If the research program passes
that hurdle, it moves forward into development. The development
process includes evaluation and selection of a product design,
completion of clinical trials to test the product’s safety and e-
cacy, and validation of the manufacturing process to demonstrate
its repeatability and ability to consistently meet pre-determined
specifications.
Similar to the diagnostic products discussed above, in the U.S.,
vascular products are classified as ClassI, II, or III. Most of
Abbott’s vascular products are classified as ClassII devices that
follow the 510(k) regulatory process or ClassIII devices that are
subject to the PMA process.
In the EU, vascular products are also categorized into dierent
classes and the regulatory process, which is governed by the
European Medical Device Directive, varies by class. Each product
must bear a CE mark to show compliance with the Directive. Some
products require submission of a design dossier to the appropriate
regulatory authority for review and approval prior to CE marking
of the device. For other products, the company is required to
prepare a technical file which includes testing results and clinical
evaluations but can self-certify its ability to apply the CE mark to
the product. Outside the U.S. and the EU, the regulatory require-
ments vary across dierent countries and regions.
After approval and commercial launch of some vascular products,
post-market trials may be conducted either due to a conditional
requirement of the regulatory market approval or with the objec-
tive of proving product superiority.
In the Nutritional segment, the research and development process
generally focuses on identifying and developing ingredients and
products that address the nutritional needs of particular popula-
tions (e.g.,infants, athletes) or patients (e.g.,people with diabetes).
Depending upon the country and/or region, if claims regarding a
product’s ecacy will be made, clinical studies typically must be
conducted.
In the U.S., the FDA requires that it be notified of proposed new
formulations and formulation or packaging changes related to
infant formula products. Prior to the launch of an infant formula
or product packaging change, the company is required to obtain
the FDA’s confirmation that it has no objections to the proposed
product or packaging. For other nutrition products, notification
orpre-approval from the FDA is not required unless the product
includes a new food additive. In some countries, regulatory approval
may be required for certain nutritional products, including infant
formula and medical nutritional products.
Depending upon the product, the phases of development may
include:
• Drug product development.
• PhaseI bioequivalence studies to compare a future Established
Pharmaceutical’s brand with an already marketed compound
with the same active pharmaceutical ingredient (API).
• PhaseII studies to test the ecacy of benefits in a small group
of patients.
• PhaseIII studies to broaden the testing to a wider population
that reflects the actual medical use.
• PhaseIV and other post-marketing studies to obtain new clini-
cal use data on existing products within approved indications.
The specific requirements (e.g.scope of clinical trials) for
obtaining regulatory approval vary across dierent countries and
geographic regions. The process may range from one year for a
bioequivalence study project to 6 or more years for complex for-
mulations, new indications, or geographic expansion in specific
countries, such as China.
In the Diagnostics segment, the phases of the research and
development process include:
• Discovery which focuses on identification of a product that
will address a specific therapeutic area, platform, or unmet
clinical need.
• Concept/Feasibility during which the materials and manufac-
turing processes are evaluated, testing may include product
characterization and analysis is performed to confirm clinical
utility.
• Development during which extensive testing is performed
to demonstrate that the product meets specified design require-
ments and that the design specifications conform to user needs
and intended uses.
The regulatory requirements for diagnostic products vary across
dierent countries and geographic regions. In the U.S., the FDA
classifies diagnostic products into classes(I, II, or III)and the
classification determines the regulatory process for approval.
While the Diagnostics segment has products in all three classes,
the vast majority of its products are categorized as ClassI or
ClassII. Submission of a separate regulatory filing is not required
for ClassI products. ClassII devices typically require pre-market
notification to the FDA through a regulatory filing known as a
510(k) submission. Most ClassIII products are subject to the FDA’s
Pre-Marketing Approval (PMA) requirements. Other ClassIII
products, such as those used to screen blood, require the submis-
sion and approval of a Biological License Application (BLA).
In the EU, diagnostic products are also categorized into dierent
categories and the regulatory process, which is governed by the
European InVitro Diagnostic Medical Device Directive, depends
upon the category. Certain product categories require review and
approval by an independent company, known as a Notified Body,