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Part 11 Q&A Guidance August 10, 2017

Posted by Michael Hamrell in Uncategorized.
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In August 2017, the FDA released a draft guidance that provides recommendations to sponsors, clinical investigators, IRBs, CROs, and other interested parties on the use of electronic records and electronic signatures under Part 11 in clinical investigations of medical products. Part 11 is the FDA regulation, published in 1997, on the use of electronic records/electronic signatures. The guidance is the first update to guidance and information regarding Part 11 compliance in clinical trials in a number of years. It clarifies, updates, and expands upon the recommendations in the 2007 Part 11 guidance that pertains to FDA-regulated clinical investigations conducted under parts 312 and 812. The guidance attempts to clarify and update recommendations for applying and implementing part 11 requirements in the current environment of electronic systems used in clinical investigations. It also encourages the use of electronic records and systems to improve the quality and efficiency of clinical investigations. The guidance also discusses the use of a risk-based approach when deciding to validate electronic systems, implement audit trails for electronic records, and archive records that are pertinent to clinical investigations conducted under parts 312 and 812. Since the use of computers in clinical trials is the norm these days the recommendations in this guidance should be helpful to everyone engaged in clinical trials.

New User Fee Laws Coming August 8, 2017

Posted by Michael Hamrell in Uncategorized.
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The Congress has just voted and authorized the Prescription Drug User Fee Act (PDUFA) for another five years. The final bills to reauthorize all the user fee programs are waiting for the President to sign them. This law, originally passed in 1992, allows FDA to collect fees associated with submission and review of a New Drug (and Biologic) Applications along with product and establishment fees. The Act requires that Congress reauthorize the law every five years. Each cycle, the reauthorization has included a review and reexamination of FDA progress in meeting review goals and protecting the public. Over the years, new aspects of FDA oversight have been included as part of the reauthorization, including the addition of REMS, requirements for post-approval studies, the development of pediatric information for labels and other initiative to encourage development of new drugs and expedite their review. The success of the PDUFA program for drugs (and biologics) led to the implementation of User Fees for medical devices in 2002 (MDUFMA) and starting in 2013, user fees for generic drugs, as well as a novel structure for user fees for biosimilar products. The law is expected to be finalized this summer to be ready for implementation in the next Fiscal Year, starting October 1, 2017. Stay tuned for more details.

What’s New in GCP August 8, 2017

Posted by Michael Hamrell in Uncategorized.
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I haven’t updated this Blog in some time, but i thought it would be a good idea to write about what is new, and not so new in GCP.

In September 2013, FDA published a Guidance on Electronic Source Data in Clinical Investigations.  This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA-regulated clinical investigations.  The guidance promotes capturing source data in electronic form.  It is intended to assist in ensuring the reliability, quality, integrity, and traceability of the data from electronic source to electronic regulatory submission.

In December 2016, the FDA also published a Question and Answer Guidance on the use of electronic informed consent.  This guidance has been prepared jointly by the Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) and the Food and Drug Administration (FDA). This guidance provides recommendations on the use of electronic systems and processes that may employ multiple electronic media to obtain informed consent for both HHS-regulated human subject research and FDA-regulated clinical investigations of medical products, including human drug and biological products, medical devices, and combinations thereof.