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Official August 2020 Approvals and Receipts for ANDAs Reported

The Office of Generic Drugs (OGD) reported some of its official statistics for August today.  As usual, the first official reported metrics deal with approval and tentative approval actions, receipt of new ANDAs, and issuance of complete response letters. The OGD reported 58 full-approval actions (which we nailed in our earlier post of unofficial stats […]

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Do You Have Your Checkbook Ready? Be sure Listings Are Made and Are Accurate!

FDA finalized its guidance entitled “Civil Money Penalties Relating to the Data Bank Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff” (quite a mouthful) today (here) which was originally issued as a draft in September 2018.  The FR Notice announcing the availability of the guidance (here) indicates […]

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Are You Ready? Because the FDA IS Getting Ready!

How has COVID 19 changed your organization?  Do you have fewer or newer employees?  Have you kept up with training requirements, or has your focus been more targeted towards keeping the freight moving?  Has your workforce stabilized with sufficient personnel to perform the complex cGMP tasks necessary and the documentation requirements expected by the FDA?  […]

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What Were These People Thinking?

A Department of Justice press release (here) announced a 19 count indictment against 9 individuals “with conspiracy to commit mail and wire fraud, mail fraud, wire fraud, aggravated identity theft, conspiracy to defraud the United States, and failure to maintain adequate records.”  Basically, the press release goes on to describe fraudulent activities relative to the […]

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