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  • Oct 24  – David Shoemaker, SVP, R&D at Rho, Inc 
  • Nov 07  Roundtable Event at Friday Center
  • Dec 12 – Sathya Ganesan, Associate Director, Regulatory Affairs, G1 Therapeutics




New FDA commissioner plans to apply clinical trials insights gained at Duke


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Today's blog is from Sathya Ganesan, Ph.D., RAC:

Lab Coat and Beyond

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By Rachel A. Hardy, MA, RAC

The company 23andMe has recently found favor with the U.S. Food and Drug Administration. On 19 Feb 2015, the agency announced it had issued marketing authorization for the company’s Bloom Syndrome carrier test, which determines whether healthy adults carry a gene variant that could cause a serious disorder in their offspring (FDA 2015a).

This marketing authorization is significant for two reasons. It marked the first time FDA had authorized a direct-to-consumer genetic test. In addition, the authorization holder, 23andMe, received an FDA warning letter in 2013 for failing to obtain marketing clearance or approval for the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) (FDA 2015a, FDA 2013). As a result, 23andMe suspended its genetic testing services except for purposes of determining ancestry (Hardy 2014).

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By Rachel A. Hardy, MA, RAC

On 27 Nov 2013, the Food and Drug Administration gained new tools to regulate drug compounding when President Barack Obama signed the Drug Quality and Security Act (DQSA). In this legislation, Congress addressed longstanding questions of the FDA’s jurisdiction over compounding pharmacies, which are licensed by the states (US House of Representatives 2013a).

Tragic events prompted Congress to act. An outbreak of fungal meningitis in late 2012, which took a toll of more than 60 deaths and at least 750 sickened in 20 states, was traced back to an injected steroid produced by the New England Compounding Center (NECC), a compounding pharmacy that was licensed by the Massachusetts Board of Registration in Pharmacy (US CDC 2013).

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By Rachel A. Hardy, MA, RAC

The federal Department of Health and Human Services encompasses many agencies, each promulgating its own sets of regulations. At times, these regulations appear to contradict one another. On 7 April 2014, a rule issued by the Center for Medicare and Medicaid Services, the Centers for Disease Control and Prevention, and the Office of Civil Rights modified the CLIA (Clinical Laboratory Improvement Amendments) regulations to allow laboratories subject to CLIA to provide patients “with copies of completed test reports” (DHHS, 2014, p. 7290).

Late last year, the Food and Drug Administration issued a warning letter to the company 23andMe for not obtaining marketing clearance or approval for the 23andMe Saliva Collection Kit and Personal Genome Service (PGS). It stated “assessments for drug responses carry the risks that patients relying on such tests may begin to self-manage their treatments through dose changes or even abandon certain therapies depending on the outcome of the assessment. … Serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported” (FDA 2013a).

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By David Jensen, PhD RAC

The Regulatory Affairs Professional Society (RAPS) has announced changes to their Regulatory Affairs Certification (RAC) requirements (read the Regulatory Focus article). Essentially, the RAC has new eligibility requirements, a new fee structure, and some minor changes to the re-certification deadlines and process.

The biggest change comes in the eligibility requirements. Starting with the Fall 2014 exam period, RAPS will require a person seeking the RAC credential to have BOTH a college degree (Bachelors or above) AND (currently this is “or”) some number of years of professional regulatory or related healthcare product experience. There is no definition given for “related healthcare product experience” nor which experience is valid and which is not. The minimum number of years of required experience depends on the level of education (Bachelors = 3 yrs; Masters = 2 yrs; Doctorate = 1 yr).

The new fee structure for the exam simplifies the registration process. No longer will there be early and late registration dates plus member/non-member rates. Now, RAPS members will pay $425 and non-members will pay $525 to take the exam. Additionally, there are new registration deadlines: March 1st for the spring exam cycle and September 1st for the fall cycle.

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By David Jensen PhD, RAC

I am not one to usually nit-pick (and having survived a month of those lousy louses with my daughters, I know what that means) but I was recently reminded that not all of my regulatory colleagues know (or remember) that the US FDA does not require “compliance with the Declaration of Helsinki.” It was at a training I recently attended in which the materials included brief reports of clinical trails; e.g. abstract, methods, tables of data. At the end of every study abstract was the phrase “This study was performed in compliance with the Declaration of Helsinki.” I was surprised to read this because the US FDA has not required such a statement of sponsors and investigators for some time; indeed the US has not been a signatory to the Declaration of Helsinki since before 2000. 

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