July 2019

30
Jul
stack of one hundred dollars notes

FDA Announces MDUFA and Outsourcing User Fee Rates for FY 2020 – All Fees Higher

In two separate Federal Register notices (here for medical devices and here for outsourcing facilities), the FDA announced the user fee amounts for FY 2020.  The FDA notes that the fees are effective on October 1, 2019 (the beginning of the 2020 FY) through September 30, 2020. The medical device fees are provided in the […]

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30
Jul
Girlfriends using a map on station

ICH Q12 – Ready or Not, Here it Comes!

California Separation Sciences Society (CaSSS) holds a two-day, highly interactive meeting with attendance from the biotechnology industry and global regulators each summer in the Washington, DC area (i.e., the CMC Strategy Forum).  This year the title of the forum was “The Future of Post-Approval Changes is Coming – Are You Ready for ICH Q12?” and […]

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26
Jul
Doctor holding a clipboard with Safety first, Medical concept

Postmarketing Study Reveals Higher Risk of Blood Clots and Death – FDA Approves Boxed Warning

Like many drugs that undergo clinical trials (even larger trials), rare adverse events may not become apparent until well after the drug is in wider use after approval.  In addition, as a condition of approval, the FDA often requires a post-approval commitment to further study the drug.  Such is the case as described in the […]

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23
Jul

Pregabalin Approvals Hit the Approval Trail, but Why So Late?

According to the FDA, OGD approved 11 ANDAs for Pregabalin (a generic for Lyrica), on Friday, July 19, 2019.  However, when looking at the Innovator product’s patent and exclusivity awards, the 180-day pediatric exclusivity expired on June 30, 2019.  This got my mind working to try to figure out why the 17-day (June 30 fell […]

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23
Jul

Potential Label Carve Out to Antidepressant Appears OK to FDA

In a 21 page response (here) dated July 18, 2019 to Citizen Petition Docket No. 2019-P-0837 (here  ), filed on February 20, 2019, the FDA determined that a carve out of an exclusivity-based and patent-based (potential little viii) statements regarding a supplemental application approval granting the inclusion of information on treatment of emergent sexual dysfunction […]

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18
Jul
Professional Baseball Batter Striking Baseball During Night Game In Stadium

Halfway through the Twenty-Two Reporting Days of July, Are OGD Approval Actions Perking Back Up?

With just eleven of the twenty-two working days left in July for the OGD to report approval actions, the number of full approval actions stands at twenty-nine and tentative approval actions sit at eight, for a total of thirty-seven so far this month.  These numbers are derived from the FDA’s All Approvals page here. Compared […]

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18
Jul

Lachman Consultants Travels to India for the 5th Annual Data Integrity, Reliability, and Quality Metrics Workshop

[vc_row][vc_column][vc_column_text css=”.vc_custom_1563454804998{padding-bottom: 25px !important;}”]Three Key Representatives from Lachman Consultants will be traveling to India on July 30 – August 1 for the 5th Annual Data Integrity, Reliability, and Quality Metrics Workshop. This 3-day interactive training event features experts from Lachman Consultants, Frances Zipp, President & CEO, Linda Evans O’Connor, Head of Business Processes and Regulatory, […]

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