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Proposed Changes to Biospecimen Consent Requirements Dropped from the Revised Common Rule

If you are conducting biospecimen-based research, you are probably aware that on January 18, the long-anticipated revised Common Rule (Title 45 of the CFR, part 46, Federal Policy for the Protection of Human Subjects) was posted to the Federal Register (for some background on the nature of these revisions, see my blog post).

Topic: Biobanking and Biorepository, Topic: Public..........

Informed Consent for Use of De-Identified Biospecimens?

The Federal Government is revising the rules governing use of humans in research, specifically, Title 45 of the Code of Federal Regulations (CFR) part 46, Protection of Human Subjects. A Notice of Proposed Rulemaking (NPRM) was issued September 5, and comments are being accepted until December 7, 2015.

Changes in the rulings include new requirements for informed consent, including consent for the use of de-identified patient biospecimens, and the duties of Institutional Review Boards.

Topic: Biobanking and Biorepository, Topic: Clinic..........

Why GMP? An explanation of Good Manufacturing Practice

GMP refers to the Good Manufacturing Practice Regulations published by the FDA under the Federal Food, Drug, and Cosmetic Act. As a response to concerns about substandard drug manufacturing practices occurring at the time, Congress enacted the 1962 Drug Amendments. These amendments instructed the FDA to require all drugs to be made according to Good Manufacturing Practice (GMP) as defined under FDA 21 CFR Part 210-211.

The first set of Good Manufacturing Practices (GMP) regulations were published in 1963. These regulations are meant to guide companies in the production of safe and effective drugs. The regulations outlined in the GMPs are the minimum requirements necessary to ensure safe and effective products.

In this blog we'll discuss the definition of GMP, various regulatory components, and why it's important for companies in the life sciences space.

Topic: Biobanking and Biorepository, Topic: Qualif..........

The 21st Century Cures Act and the Glacial Pace of Drug Development

Since the mapping of the genome, there has been a growing expectation that a flood of transformative therapies would re-define medical practice and patient care. But this flood is still a small trickle, and the Federal government is attempting to craft legislation to speed development and eliminate some logjams. Where are the logjams? Not at the FDA or NIH.

The much-discussed 21st Century Cures Act (introduced in the House of Representatives last May, passed on July 10, and now in the Senate), is intended to encourage innovation, give the FDA greater leeway to consider non-traditional sources of data and clinical studies, and shorten the time between application to the FDA and approval.  The consensus among some industry experts is that the Act is a “mixed blessing.” This list juxtaposes some elements of the Act (in no particular order) with some recent commentary.

Topic: Biobanking and Biorepository, Topic: Clinic..........

FDA Proposes New Approach for the Regulation of NGS-Based Genetic Testing

In February of 2015, the US Food and Drug Administration (FDA) released a nine-page paper entitled “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests—Preliminary Discussion Paper” that, among other ideas, proposed allowing the use of curated third-party databases to support submissions for FDA approval, rather than requiring new studies and the support of existing literature.

This represents a noteworthy change in the way diagnostic tests may be developed: the evidence supporting the clinical relevance of results will come from the community, not from the test developer!

Topic: Industry News, Content: Blog

The Road to Personalized Medicine: FDA's Proposed Guidelines on Companion Diagnostics


While regulation of diagnostic tests by the Food and Drug Administration (FDA) may not directly impact the biobanking industry, it does have an impact on the development of new therapies, particularly personalized medicine, and all of us have a stake in the future of personalized medicine.

The FDA is actively encouraging the development of personalized medicine and regenerative therapies, and has taken a significant step on behalf of companies that are developing these products by enforcing regulatory oversight of the corresponding diagnostic tests. The FDA's August 2014 announcement,  In Vitro Companion Diagnostic Devices / Guidance for Industry and Food and Drug Administration Staff, provided further guidance to those companies developing therapeutic products and/or in vitro companion diagnostics.  Shortly after this announcement was made the FDA sent a proposed risk-based framework for regulatory oversight to Congress for approval.

Topic: Industry News, Content: Blog