On July 31, 2014 the FDA notified Congress of the Agency’s intent to issue a draft oversight framework for Laboratory Developed Tests (LDTs) based on risk on patients.

This is a change from the current framework where regulatory oversight is determined based on whether the LDT is made by a conventional manufacturer or a single laboratory. FDA released the draft guidances describing the regulatory oversight for LDTs, which uses a risk-based approach and will be implemented over the course of multiple years.

The agency intends to enforce device registration and listing with the FDA for most LDTs. In addition, the agency will require the LDT manufacturers to submit adverse event reports to enable better post-market surveillance monitoring. For high and moderate-risk LDTs, the FDA intends to have pre-market review and will enforce the quality system regulation, which affects design controls and the manufacturing of LDTs.

Under the draft framework, the FDA will continue to exercise enforcement discretion for low-risk LDTs and LDTs for rare diseases and unmet needs. Laboratories and hospital systems that rely on the use of LDTs in their clinical practice should be familiarized with the FDAs proposed LDT regulations. The anticipated regulations are an overhaul of the current landscape, but will mostly promote safe and effective use of all in vitro diagnostic devices.

What is a Laboratory Developed Test?

An LDT is an in vitro diagnostic product (IVD) that is designed, manufactured, and used within a single laboratory. To create the LDT, laboratories use reagents and analyte specific reagents combined with general laboratory instruments to develop test protocols, which are then verified and validated to provide a clinical diagnostic result.

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On Monday, August 3, 2015, the Food and Drug Administration announced its fees for the Generic Drug User Fee Amendment Program.

These fees apply to abbreviated new drug applications, prior approval supplements to approved abbreviated new drug applications, facilities that manufacture the active pharmaceutical ingredients for generic drugs, and facilities that manufacture finished dosage forms.

Because any final dosage forms or active pharmaceutical ingredients can be deemed misbranded and pharmaceutical companies can be prosecuted if the fees are unpaid, any pharmaceutical company manufacturing an active pharmaceutical ingredient, a generic drug, submitting a generic drug for approval, or maintaining a drug master file for a generic drug..

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The manufacture, monitoring, and marketing processes for a pharmaceutical after it is approved are as important as the steps involved in developing it and submitting for approval.

In fact, some unique issues can occur during the postapproval phase. These issues can be divided into three primary categories: chemistry, manufacturing, and control issues; regulatory issues; and business-related issues. As such, pharmaceutical executives should understand the issues involved in each category.

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In 2002, FDA launched an initiative entitled, “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” to encourage the implementation of a modern, risk-based pharmaceutical quality assessment system.

In an effort to support that initiative, FDA released a draft guidance document titled “Request for Quality Metrics: Guidance for Industry” in July of 2015. This draft guidance document includes the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research’s (CBER) proposal on the data and quality metrics they intend to collect to support continuous improvement in the pharmaceutical manufacturing industry.

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