Weekly Roundup 4.13.18

For those of superstition, it is the first of two Friday the 13ths for this year. For the rest of us, we are assessing our bad luck with regard to the fact that if you live in the mid-Atlantic it appears that we will have our annual late wintery weather, followed by 20 minutes of Spring, followed by a long, hot summer. In any case, as folks returned from Easter vacation, Congress was back in session and when not focused on Facebook, was having hearings on opioids. And FDA, who did not take a break, was busy too.

Here is a bit of what happened this week.

  • FDA Finalizes  Two Guidance Documents on Next Generation Sequencing  (NGS) Tests – FDA has been charged with enhancing innovation via, among other means, of reduced regulatory burden. This week FDA issued two guidance documents on NGS Test development that the agency said in its release would enhance the ability to deliver targeted treatment. According to the Commissioner, the guidance documents provide a more modern framework for the development and evaluation of such tests. The first guidance allows for developers to rely on a clinical evidence from FDA recognized databases to support claims in relations to efficacy. The second guidance makes recommendations for designing, developing and validating tests for genetic diseases. In a speech given the same day of the release before the 2018 Community Oncology Conference, Dr. Gottlieb provided additional perspective on the two guidance documents and their impact. 
  • FDA Guidance on Moderate Risk Devices to Utilize 510(k) Clearance  – To gain marketing clearance for a moderate risk medical device, manufacturers have been required to test the device under development against an existing (predicate) device already approved to demonstrate safety and efficacy.  But under a new guidance proposed by FDA this week, such a manufacturer might instead be permitted to volunteer to use a different pathway which would allow clearance if the manufacturer demonstrated that the device meets a set of objective, established criteria instead. According to the FDA, the predicate device and the new device are often very different given advances in technology, presumably setting up the comparison of an apple to another really different apple. This has been another in a line of new policies which are termed “modernizing” FDA’s regulatory approach by easing the regulatory burden on manufacturers. The objective is to do so without compromising FDA’s gold standard on safety and efficacy. 
  • First Generic Approvals – FDA updated its list of 2018 First Generic Approvals. In 2017 there were 80 such approvals during the year which had been a banner year for generic approvals overall. It has been said that this year will also see a large number of approvals. The 2018 list has 12 such approvals so far for the year, while in 2017 by the end of the first quarter there were also 12 approvals. This year, therapeutic categories touched by the approvals included secondary parahyperthyroidism and HIV. 

Things to Keep an Eye on This Week

Regulatory Developments in Pharma/Biotech/Devices

Photo by Atul Vinayak on Unsplash


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