FDA’s push for KASA platform over eCTD tops RAPS list of most-read articles of 2018

By PharmaCompass

2018-12-20

Impressions: 559 Article

Do you know the most read article of 2018 by the Regulatory Affairs Professionals Society (RAPS)? According to RAPS, it was on FDA pushing for the adoption of a new Knowledge-aided Assessment & Structured Application (KASA) platform, published in September this year.

The article focuses on the positive aspects of adopting a KASA platform to replace the electronic common technical document (eCTD).

RAPS has listed out the top 10 most-read stories of 2018. At number two was a story on FDA’s new real-world evidence (RWE) framework and how companies can win new indications for approved drugs and biologics, expand labels or satisfy post-approval study requirements with RWE.

At number three was a story on an FDA director moving to AstraZeneca. The article focuses on several FDA employee departures and moves between the agency and industry.

At number four was an article that discusses a final FDA guidance on when a standard release test and criteria may be used in lieu of extensive method development and acceptance criteria-setting exercises. On number five was a story on FDA unveiling six new draft guidances on gene therapy.

The RAPS compilation also includes articles on FDA proposing new option for device companies to apply for 510(k) clearance; Philips Medical Systems drawing lengthy FDA 483 over issues with thousands of complaints; on six Asian Firms being blocked for refusing FDA inspections; and an article on what MHRA expects post Brexit.

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