Regulatory Affairs

17
Apr

Data Integrity: A View from Down Under

Following the lead of many of the world’s pharmaceutical regulatory agencies, on April 6, 2017, the Australian Therapeutic Goods Administration (TGA) released a Data Management and Data Integrity (DMDI) policy statement. TGA states that the policy “serves to provide some clarification regarding the TGA’s official position regarding DMDI practices for industry,” but at the same […]

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05
Apr

OGD Approvals Look About the Same

According to our tracking of OGD approvals for March 2017 through the daily listings of approvals on Drugs@FDA: FDA Approved Drug Products (which was fairly close to the final numbers last month), there appears likely to be 59 full ANDA approvals and 16 tentative approvals reported when OGD issues final numbers in its Activities Report […]

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03
Apr

This Could Make Your Head Spin

Seems like almost every day a new Federal or State law is proposed to deal with drug pricing for both brand and generic pharmaceuticals. .  The latest entries that appear to be making progress through the legislative process are from the states of Washington and Nevada. One can just imagine that there are specific differences […]

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29
Mar

Here’s Good News, Sports Fans – Submission Dates are Back in Approval letters

Ever since I can remember, the submission date of an ANDA has been reported in the approval letter of the application.  That practice stopped in early 2016, as reported in our blog post (here). The submission dates of applications are important metrics that help the industry to track approval times for applications.   We heard a […]

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