Home | Contact Us | Newsletter | Usersclub | Books | Audio Seminars

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The FDA just introduced a new draft guidance: Protecting the Rights, Safety, and Welfare of Study Subjects - Supervisory Responsibilities of Investigators.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.

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.

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.