Labcompliance News, June 2007
June 20, 2007
New FDA Guidance Welfare of Study Subjects and Supervisory
Responsibilities of Investigators
The FDA just introduced a new draft guidance: Protecting the
Rights, Safety, and Welfare of Study Subjects - Supervisory
Responsibilities of Investigators. The document provides an overview
of the responsibilities of a person who conducts a clinical
investigation of a drug, biologic, or medical device (an
investigator as defined in 21 CFR 312.3(b) and 21 CFR 812.3(i)). The
intent of this guidance is to help investigators meet their
responsibilities with respect to protecting human subjects and
ensuring the integrity of the data from clinical investigations. The
guidance is quite detailed, for example it clarifies what 'adequate
training of staff ' means The guidance can be downloaded from the
FDA website.
June 20, 2007
32 New Documents in the Labcompliance Usersclub
We have added 32 new documents to the Labcompliance UsersClub.
They include SOPs, checklists/ templates/examples, FDA presentations
and guidance documents and FDA warning letters/483's related to
GMP/GLP or GCP. User club members can instantly
download the new
additions. To see the list and ordering the users club,
click here, and scroll
down to 'new additions'. With these additions, the UsersClub has
more than 350 documents ready for download.
June 20, 2007
FDA Continues to Inspect for 'Part 11' Requirements
Even though not referenced directly, Part 11 deviations continue
to be cited in FDA inspection reports. An example is a warning
letter from May 9, 2007. "Inadequate storage and back-up of
electronic records, missing ability to discern invalid or altered
electronic records, access to computer records without unique user
ID and password, no or inadequate validation, inaccurate copies of
electronic records and no data encryption" have been listed as
deviations. Many companies still believe that the FDA does not
enforce Part 11 because of enforcement discretion statements as per
the Part 11 guidance from 2003. The reality looks different. In
recent warning letters the FDA does not quote Part 11 but refers to
deviations related to security, authenticity, accuracy and integrity
of data. These are primary requirements of all predicate rules. Here
are just a few of many examples from the letter: "No changes in the
study data could be detected as there was no audit trail capability;
and finally, the electronic data did not correlate with the paper
records" and "Your response is inadequate because no system
validation was conducted to ensure accuracy, reliability, consistent
intended performance, and the ability to discern invalid or altered
records". The Warning Letter can be downloaded from the
Labcompliance Users Club.
Non members can
preview excerpts.
June 20, 2007
New FDA Guidance on Chemistry, Manufacturing and Control Changes
to an Approved NADA or ANADA
On May 30, 2007, the FDA has released the guidance for industry
entitled ‘‘Chemistry, Manufacturing, and Control Changes to an
Approved NADA or ANADA.’’ This guidance is intended to provide
recommendations to holders of new animal drug applications (NADAs)
and abbreviated new animal drug applications (ANADAs) on how they
should report certain changes to such applications, in accordance
with the final regulation, 21 CFR 514.8, which was issued in the
Federal Register of December 13, 2006 (71 FR 74766). The guidance
covers recommended reporting categories for post-approval changes
for animal drugs. The document can be downloaded from the
FDA website
June 20, 2007
FDA Issues Draft Guidances for Online Access of Bioequivalence
Studies for Generic Drugs
The FDA announced the availability of draft guidances for
industry that describe recommendations on how to design
bioequivalence
(BE) studies for 200 specific drug products to support abbreviated
new drug applications (ANDAs). These draft guidances are being made
available concurrently with the publication of a draft guidance for
industry entitled ``Draft Guidance for Industry--Bioequivalence
Recommendations for Specific Products'' (product specific BE
recommendations). This draft guidance describes the new process for
making available guidance on product-specific BE studies. Under the
process described in the draft guidance, draft and final
product-specific BE study guidance will be made available on the FDA
Web site. To read more,
click
here.
June 20, 2007
Sponsor of Clinical investigation Receives Warning Letter for
Inadequate Monitoring of the Investigation
FDA regulators inspected a sponsor of clinical investigations
from February 21 through March 8, 2007, and found practices that did
not conform with applicable federal regulations. For example: "There
were repeated deviations from the investigational plan, spanning
several years, with no apparent steps taken to bring the clinical
investigators into compliance, which indicates failure to ensure
investigator compliance". In addition "The company failed to ensure
adequate monitoring of the investigation", The FDA made it clear
that is a sponsor's responsibility to ensure adequate monitoring of
a clinical investigation. The purpose of monitoring is to ensure
protection of human subjects, and secure compliance with the signed
agreement, investigational plan, and applicable regulations. It is
not the frequency that is the issue but the assurance of
investigator compliance as well as the completeness, and accuracy of
case histories The Warning Letter can be downloaded from the
Labcompliance
Usersclub Non members can
preview
excerpts.
June 20, 2007
Implementing the FDA Guidance on 'Using Computerized Systems in
Clinical Investigations'
On May 8, 2007, the FDA announced the release of the final
Guidance for Industry: Using Computerized Systems in Clinical
investigations. In the QA/QC News of Agilent Technologies Ludwig
Huber wrote an overview with sections on differences between the
draft and the final guidance, on key requirements and
recommendations for implementation. Most important recommendation is
to define each step on how the computerized system is used in a
study and on how source data and other records are created,
processed, transmitted and archived. This is best done through
graphics supported by numbered step-by-step description. Click
here to read the article.