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 charts below,

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 it focused on the draft International Conference on Harmonization (ICH) Q12 guideline (here) which addresses the technical and regulatory aspects of reporting post-approval changes to the regulatory bodies. 

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 updated Safety Communication released today by the Agency as FDA announced it approved “a Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz,

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 on a Sunday) delay occurred,

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 would not make an ANDA product less safe or effective than the reference listed drug.

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.

Approval Rate for Therapeutic Monoclonal Antibodies Continues to Grow

Now that we have passed the midpoint of 2019, it seemed like a good time to take a look at how the FDA and industry are doing at getting biotechnology product applications approved, and put this into historical perspective.

Between 1965 and the end of Federal Fiscal Year 2013, the FDA had approved approximately 86 therapeutic biopharmaceutical products (TBPs).  

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

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, and Dr. Ron [...]

Can We Call It the Affirmation of a “Beautiful Friendship”?

FDA has announced the availability of another draft guidance for industry entitled, Harmonizing Compendial Standards with Drug Application Approval Using the USP Pending Monograph Process.  The draft guidance is part of FDA’s continued support of the Drug Competition Action Plan and to encourage the generic industry to take advantage of the USP’s Pending Monograph Process that was initiated in 2015.

Understanding the Mutual Recognition Agreement (MRA)

It certainly seems that the world is getting smaller and this concept has been coming to the regulated industry for quite some time now.  As early as 1999, the European Commission has been working diligently with the EMA and other regulatory bodies throughout the world to form Mutual Recognition Agreements (MRAs) related to inspections and to harmonize standards within the industry.  

New FDA Guidance Released on Live Case Presentations for IDE Clinical Trials

We are living in a world that is constantly changing and using forms of media such as videos and live recordings as forms of communication, notification, training and archiving of special events.  In this age, we are constantly bombarded with Tweets, G-Chats and Facebook posts that have videos attached.  We can stream tv shows, live news reporting and sports events in real time.  

We Were Close – June Was A Bit Of A Bust

OGD released its official approval and receipt numbers on Wednesday afternoon and, as was predicted (almost) in our previous blog (here), it was somewhat disappointing.  We missed the approval actions by one.  OGD actually issued 45 approval actions (we found only 44), and they issued 17 (as predicted) tentative approval actions for a total of 62 approval actions for June 2019. 

Ready or Not Here They Come – Lab Regulatory Inspections

Like death and taxes, eventually every pharmaceutical testing laboratory will get a regulatory agency inspection.  The anticipation of a regulatory inspection will instill great angst even within the most compliant laboratories.  The anticipated inspection might be a periodic inspection, but most often is a Pre-Approval Inspection (PAI).  The anxiety about an impending inspection often triggers a request for an independent third-party audit of the facility including the laboratory.

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