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How Current is Your Stability Program?

A quick survey of recent FDA Form 483s shows that firms are struggling to meet FDA expectations for timeliness of stability testing.  During the last twelve months, the FDA has issued at least sixteen Form 483s for observations related to the timeliness of stability sample testing.

Neither the current guidance ICH Q1A(R2) “Stability Testing of New Drug Substances and Products” nor the FDA November 2003 Guidance for Industry “Q1A(R2) Stability Testing of New Drug Substances and Products” details the expectations for the timeliness of stability sample testing.  

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Controlled Correspondence Made Easier, But Watch Out

On October 1, 2018, the FDA opened a portal (here) that permits firms to submit Controlled Correspondence (CCs) directly and electronically to the FDA.  The process is further explained here, including how to register for use of the portal.  This could help speed CCs to the Agency, but it is the problem with what happens to some once they reach the Agency that has raised some industry eyebrows,

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The Importance of Trending During Laboratory Investigations

It is understandable that during an investigation the initial focus is determining the cause along with the associated impact assessment and the identification and implementation of a corrective action.  However, what can get overlooked during the investigation process is the importance of trending.  This is a key component of root cause confirmation, assessing the appropriateness and effectivity of corrective action and determining whether there are any underlying cause/s for noted repeat incidents.

OGD Breaks FY Record on Approvals!

Despite a slow start to FY 2018 due, in most part, to the elemental impurities issue, the Office of Generic Drugs (OGD) has broken the FY record for number of approvals.  We are not quite sure by how much just yet because the numbers can continue to roll in over the next few days, but as it stands now,

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Me KASA es Su KASA – Long Overdue but Very Welcome

On Thursday (September 20th), the FDA held a meeting of the Pharmaceutical Science and Clinical Pharmacology Advisory Committee to discuss the Agency’s plans for implementation of the Knowledge‑aided Assessment and Structured Application program (KASA).  The FDA presented to the Advisory Committee two primary goals of the KASA program.  On the one hand, it is intended to make the review of the CMC section of NDAs,

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Final ANDA Submission Guidance Published Today

The FDA has updated and finalized its guidance “ANDA Submissions – Content and Format”   (here). The 38-page document goes into even more detail than the previous drafts and provides expanded explanations for certain sections and requirements for documents.

There is advice for each eCTD section and even an expanded Cover Sheet format suggested in Appendix A of the document. 

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FDA Takes Action on Opioids – Approves Final REMS

Yesterday the FDA announced the approval of a final REMS “governing the use of immediate-release opioid analgesic medications.”  And the FDA did it in a big way, approving some 437 supplements for the various immediate-release opioid products.  The FDA stated in its new release (here):

This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals.  

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FDA Is Eliminating Regulations? Here’s One that Makes Sense!

The FDA has announced a proposed rule to repeal its regulation requiring any drug product that uses irradiation to be approved under an NDA or ANDA.  The Notice states that “this action is part of FDA’s implementation of Executive Orders (EOs) 13771 and 13777.  Under these EOs, FDA is comprehensively reviewing existing regulations to identify opportunities for repeal,

August Official Approvals and Receipts Released as OGD Approaches Record Year

The Office of Generic Drugs (OGD) released its official approval and receipt numbers late yesterday.  August saw 53 full approvals and 15 tentative approvals, leaving OGD 44 ANDA full approvals away from matching their previous FY record of 763 from FY 2017.  These approvals are quite an accomplishment given the fact that the slowdown in the first few months of calendar year 2018 was so drastic.

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No Easy Solutions for Complex Generics Yet

The Complex Generic Drug Development Workshop is currently being held in Silver Spring, Maryland September 12‑13, 2018.  In her keynote address at the FDA’s Small Business and Industry Assistance (SBIA) workshop on complex generic drug development, Kathleen Cook Uhl stated that complex drug products are critical to the care of many serious medical conditions, such as multiple sclerosis,

Female chemist at work in laboratory.

Reduced Testing, but Not Reduced Expectations

Reduced testing of Active Pharmaceutical Ingredients (API), excipients, and other raw materials can be a valid approach to gaining overall efficiencies in the pharmaceutical quality control laboratory.  However, the choice of tests to perform and the justification for choosing those tests are key elements of operating a compliant Reduced Testing Program that is also scientifically sound.

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Bending, Breaking or Moving On: FDA Expands on its 2018 Compounding Policies Priorities

On September 7, 2018, FDA Commissioner Scott Gottlieb stated that the FDA will expand on their implementation of their 2018 Compounding Priorities Plan and that they feel like they must continue to balance the need to preserve access to appropriately compounded drugs for patients who have a medical need for these products with the need to help protect patients from poor quality compounded drugs that could potentially cause harm to patients.