Labcompliance News, August 2009
In a
presentation at the Food and Drug Law
Institute (FDLI) the new FDA commissioner, Margaret Hamburg
announced changes in FDA's enforcement practices. The planned
changes have also been published in a
press release and comprise six major steps:
- Set post-inspection deadlines.
- Take responsible steps to speed the
warning letter process.
- Work more closely with FDA’s regulatory
partners.
- Prioritize follow-up on warning letters
and other enforcement actions.
- Be prepared to take immediate action in
response to public health risks.
- Develop and implement a formal warning
letter “close-out” process.”
FDA's New Enforcement
Program will Begin on September 15, 2009
The program had already been announced by the
new commissioner Margaret Hamburg in early August. It will support
public health protection by facilitating the timely issuance of
warning letters and other regulatory actions. The program
establishes a timeframe for the submission and agency review of
post-inspection responses to inspectional observations that are
communicated to a firm through issuance of a FDA 483 form. For
example, FDA only allows 14 days to respond to a 483 form
inspectional observations, otherwise it will not taken into
consideration for warning letters. The purpose of this program is to
optimize FDA resource utilization, facilitate the timely issuance of
warning letters, and promote prompt correction of violations. To
read more details, download the
Federal Register notice as published on August 11, 2009.
FDA Inspection Package
Version 4 Released
Labcompliance has developed a new release of
it's popular FDA Inspection Package. It includes more SOPs, an new
85 pages Inspection Survival, most recent FDA guidelines and the
complete audio seminar presentation on FDA inspections. It is
ideally suited to prepare your department, your site, and your
entire organization for FDA inspections in the U.S. and
international countries. It addresses FDA's new enforcement
practices starting in Sept 2009 and includes SOPs for Responding to
483's and Warning letters. For more information and ordering
click here.
FDA Launches New Center for
Tobacco Products
On August 19, 2009, US FDA launched its new Center for Tobacco
Products in an historic effort to curb the hundreds of thousands of
deaths caused by those products each year. The Center will oversee
the implementation of the Family Smoking Prevention and Tobacco
Control Act signed by President Obama in June 2009. The FDA’s
responsibilities under the law include setting performance
standards, reviewing premarket applications for new and modified
risk tobacco products, and establishing and enforcing advertising
and promotion restrictions. For more details,
click here.
New FDA Guidance for Control
of Melamine Contamination
The Food and Drug Administration announced in a
Federal Register notice of August 7, 2009, the availability of a
guidance for industry entitled ‘‘Pharmaceutical Components at Risk
for Melamine Contamination.’’ This guidance provides recommendations
that will help pharmaceutical manufacturers of finished products,
repackers, other suppliers, and pharmacists who engage in drug
compounding to better control their use of at-risk components that
might be contaminated with melamine. The guidance can be downloaded
from the
FDA website.
New FDA Guidance on
Postmarketing Studies and Clinical Trials
The Food and Drug Administration announced in a
Federal Register notice of July 15, 2009, the availability of a
draft guidance for industry entitled ``Postmarketing Studies and
Clinical Trials--Implementation of Section 505(o) of the Federal
Food, Drug, and Cosmetic Act.'' The Food and Drug Administration
Amendments Act of 2007 (FDAAA) added new provisions to the Federal
Food, Drug, and Cosmetic Act (the act) authorizing FDA to require
certain postmarketing studies and clinical trials for prescription
drugs and biological products approved under the act or the Public
Health Service Act (the PHS Act). This draft guidance provides
information on the implementation of the new provisions. The new
guidance can be downloaded from the
FDA website.
New FDA Guidance on Impurities
in Drug Substances
The Food and Drug Administration announced in a
Federal Register of July 15, 2009, the availability of a
guidance for industry entitled ``ANDAs: Impurities in Drug
Substances,'' which is a revision of a guidance for industry of the
same name that published in November 1999. The guidance provides
recommendations for applicants on what chemistry, manufacturing, and
controls (CMC) information to include regarding the reporting,
identification, and qualification of impurities in drug substances
produced by chemical synthesis when submitting original abbreviated
new drug applications (ANDAs); drug master files (DMFs), including
type II DMFs; and ANDA supplements for changes in the synthesis or
processing of a drug substance. The guidance can be downloaded from
the
FDA Website
Free Document of the Month
As a 'Thank You' for our visitors
Labcompliance offers every month one document for free. This month's
document is the SOP: Laboratory Failure Investigations . To download
your free copy, go to the
FDA Inspection Package website. Scroll down and click on
the corresponding ICON on the left (offer expires on July 31, 2009).
Labcompliance offers more than 100 SOPs that help to comply with FDA
and ISO 17025 compliance. For titles and ordering, click
here.
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