FDA is finding LDTs need more regulatory attention to protect patient health

According to Emily Wasserman of Fierce Medical Devices, “FDA is calling for more oversight of lab-developed tests (LDTs)”.  In a recent congressional hearing, FDA reviewed 20 case studies where certain LDTs “may have caused or have caused” harm to patients.  With this information, it seems that the current Clinical Laboratory Improvement Amendments (CLIA) regulations for LDTs are not comprehensive enough and more regulatory attention is required to protect patient health.

To check out Wasserman’s article click here.  Need help with mapping out your regulatory path for an LDT?  Contact us at Pearl Pathways.

FDA releases best practices drug development draft guidance

Melissa Fassbender, inPharma, recently published an article about the US Food and Drug Administration (FDA) and the new draft guidance on best practices for drug development. Stephen King, FDA spokesman, stated that the guidance’s purpose “is to describe best practices and procedures for timely, transparent, and effective communications between investigational new drug application (IND) sponsors and FDA at critical junctures in drug development, which may facilitate earlier availability of safe and effect drugs to the American people.” The guidance, being finalized in 18 months, will act as nonbinding recommendations.

To read Fassbender’s article, click here. To submit comments to FDA regarding this draft guidance, see this link.

FDA developing regulations for NGS

The US Food and Drug Administration (FDA) is planning to develop ways to better determine accuracy of predictions from regulatory testing of next-generation sequencing (NGS), according to FDA Commissioner nominee Robert Califf.

Michael Mezher states that FDA has been working on this development as part of the Obama Administration’s Precision Medicine Initiative. FDA is considering multiple approaches, such as a flexible design concept approach and a performance standards approach.

Up next, FDA will be hosting two workshops in the first quarter of 2016 to discuss further the plan and retrieve insight from the public. To read Mezher’s article on raps.org, click here. For more information about the November workshop held by FDA, click here. Need help with your regulatory path for your NGS diagnostic? Contact us.

FDA must clarify flexibilities

The U.S. Food and Drug Administration (FDA) has been called by multiple organizations to clarify its “regulatory flexibility” with orphan drug reviews, according to Michael Mehzer, RAPS. FDA released a draft guidance in August addressing the most common issues faced by drugmakers developing treatments for rare diseases. While many organizations, such as the National Organization for Rare Disorders (NORD), support the guidance, they request more specific information and examples on nonclinical studies, national history studies, endpoint identification, and trial design.

To read Mehzer’s article, click here. Need assistance in managing your orphan drug designation or regulatory filing? Contact us.

CDRH increases foreign inspections as planned

The U.S. Food and Drug Administration’s (FDA) Center for Device and Radiological Health (CDRH) released new data stating that the number of quality systems surveillance inspections for foreign manufacturers increased by 30%, despite the minor overall growth from 2013 to 2014. The increase in foreign inspections provides evidence that the center’s efforts have been working, according to Zachary Brennan, RAPS.

Currently, Chinese manufacturers are requiring more inspections, with Germany and Japan following suit. Although inspections increased abroad, the result of warning levels decreased. The chart below demonstrates the outcomes from domestic inspections compared to foreign inspections.

inspection outcomes

To read Brennan’s article on raps.org, click here.

FDA to exempt genetic screening systems

FDA is contemplating the exemption of specific genetic screening systems that would test parents for conditions that they may pass down to their children; however, FDA states that not all autosomal recessive carrier screening gene mutation detection systems will be included in the exemption.

According to Zachary Brennan, “FDA may exempt a device if the agency determines that a 510(k) application is not necessary to provide reasonable assurance of the safety and effectiveness of a device.” Currently, the screening is only able to determine carriers of the genes, which have caused false positive results and unnecessary psychological distress.

FDA will make its final decision within the next 120 days. For the FDA report, click here. To find out more, visit the article.

New case study from CDER

FDA Center for Drug Evaluation and Research (CDER) recently announced the release of a new case study, “Drug Approval: Bringing a New Drug to the Market,” to accompany their efforts of advancing the knowledge of drug regulatory processes within the industry. According to FDA, this case study uses real world scenarios within exercises and quizzes to promote learning and development. Its purpose is to educate on the subject of the drug approval process, and how to successfully navigate it.

For more information, click here.

Pearl Pathways to present at the ACRP symposium

Pearl Pathways will be presenting and exhibiting at the ACRP 15th annual fall symposium about excellence in research. The event will be held at the Sheraton Hotel in Indianapolis on November 6th, from 7:30AM-5:15PM. Pearl Pathways’ speakers include Gretchen Bowker, speaking on FDA audit tips, and Mary Anne Gfell and Patti Hunker, acting as panelists for the discussion, “FDA Form 483’s: The Truth of its Impact for Your Site,” and Diana Caldwell as moderator. To see event details, click here.

FDA aims to hold greater influence in global industry

Recently, Director of the Center for Drug Evaluation and Research at FDA, Janet Woodcock, addressed questions regarding the generic drug user fee act (GDUFA) and whether or not it will provide FDA the means to ensure quality. Woodcock stated that, while it’ll help fund globalization, currently it has limited impact. According to Nick Taylor’s article in In-Pharma, FDA has been attempting to oversee the global pharmaceutical supply chain. FDA is less interested in funding for increased resources, but more for powers to compliment the funds. They aim to bring to attention the problems with importing drugs in the US compared to other countries. Questions have risen regarding whether that would call for different domestic and overseas standards for manufacturers.

For a closer look, click here.

ANDAs approved by FDA

FDA recently announced the approval of the Acceptability of Draft Labeling to Support ANDA Approval guidance. This new guidance states that it is no longer required to submit a final printed label (FPL) to the Office of Generic Drugs in order to approve Abbreviated New Drug Applications (ANDAs).

Previously, the Office of Generic Drugs (OGD) required the submission of FPL because of the accurate layout and design specifications that accompany it in regards to formatting. With electronic submissions becoming more prevalent, the OGD was able to approve labeling review through electronic versions. All drafts must reflect the correct formatting factors, such as colors, font, layout, and information, in order to be considered for approval.

For more information, read Zachary Brennan’s article on RAPS.org. Need help with filing an ANDA regulatory submission? Contact us.