In 1984, Congress passed the
Drug Price Competition and Pat-
ent Term Restoration Act , better
known as the Waxman-Hatch
Amendments. This important leg-
islation was designed to increase
the availability of generic drugs. It
also created the abbreviated new
drug approval (ANDA) process.
One incentive to create a generic
was 180-day market exclusivity.
The first ANDA filed with FDA
challenging the brand name pat-
ent was entitled to 180-day exclu-
sivity after ANDA approval—no
other identical generic could be
sold.“First to market”essentially
assured large market share for life
of the product. The same benefit
applied to the first approved ge-
neric for an off-patent drug.
Given these financial incentives
and the outcome of“being sec-
ond or third,”many generic com-
panies decided to cheat. ANDA
data was falsified and FDA review-
ers were bribed...To be continued.
GENERIC DRUGS - ANDAs, EXCLUSIVITY AND CHEATING
MICROSOFT WORD AND PROTOCOL MANAGEMENT
It is estimated that Word users
only utilize about 15% of Word’s
features. Developer is an over-
looked ribbon tab containing con-
tent controls that expedite and
manage protocol development.
Validation protocols and reports
are QA documents that must be
consistently formatted and visu-
ally appealing. Individuals cannot
be allowed to revise boilerplate
text to suit personal preferences.
Problems often arise when ap-
proved protocols, not templates
are edited. Unless editing restric-
tions are imposed, protocols of-
ten drift away from the template.
Restrict Editing and Controls
are two useful features in Devel-
oper. Select template boilerplate
text and prevent revisions with
Restrict Editing. Controls limit
what variable information can be
added to a protocol or report.
William Garvey and Associates
by going to File/
Ribbon, and then
select the Developer
William Garvey and Associates provides
validation and Quality-related services to the
regulated industries—pharmaceuticals, biologics
and medical devices.
Our services include protocol development
and execution, GMP and technical training, and
validation project management.
Follow us on Google+, Facebook or LinkedIn,
or on the web at www.wgarvey.com.
OIL IN COMPRESSED AIR
There are currently two
common ways to de-
termine oil content in
oil mist tubes and gas
Dräger tubes are single-
use and inexpensive. GC
is rarely used, although
it is more accurate and
precise. Dräger testing or
GC sample collection is
performed at usepoints
far from the compressor.
Courtesy of Atlas Copco