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 FDA released a draft guidance in August addressing the most common issues faced by drugmakers developing treatments for rare diseases.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.

How to avoid 483 observations

In an In-Pharma article by Dan Stanton, Robert Fish discusses how to avoid 483 observations during audits. Fish, who served as FDA inspector for over 30 years, stressed the importance of knowing application details and training employees through mock inspections.

In order to make a positive first impression, the site must be orderly and all interactions must be courteous and respectful. FDA has the right to question whomever they choose, so it is in a company’s best interest to encourage employees to be honest, but not over-informative.

To read Stanton’s article, click here. Need help with 483 or warning letter remediation? The team at Pearl Pathways can help. Contact us.

Pentagon working alongside Silicon Valley

The Pentagon recently contributed $75 million to an initiative called “Flexible Hybrid Electronics Manufacturing Innovation Hub” in Silicon Valley. According to PARC, the market for flexible electronics is growing exponentially and is expected to reach $45 billion globally by 2016. “Flexible electronics are lightweight, rugged, bendable, rollable, portable, and potentially foldable.”

FDAnews reports that the supported initiative aims to develop technology that would replicate skin on wounded troops abroad, or be used in situations with limited medical care, such as ships and aircraft. The Pentagon’s collaboration is part of an Obama administration attempt to increase innovation and investment in the industry, while uniting Silicon Valley with the Defense Department.

For more information, click here.

Definition of “interchangeable” key to future of biosimilars

With the approval of Zarxio (filgrastim-sndz), copycat of Amgen’s Neupogen (filgrastim), there has been much speculation on the word interchangeable vs. just a biosimilar, which is Zarxio’s status. According to FDA, a product is interchangeable if it is intended to produce the same result as the original in any patient. Janet Woodcock, CDER director, spoke recently on behalf of the Senate Subcommittee about how the FDA must wait until the guidelines are bulletproof before releasing to the public. Industry is frustrated as they want to obtain the higher interchangeable status but how to prove that remains unknown until FDA publishes final guidance.

Francis Megerlin, the Berkeley Center for Health Technology, stated that the growing use of interchangeable products could cause “a long-lasting competition for chronic treatments,” while also lowering prices by insurers. It is hard to say how much prices will decrease in comparison with the original products and it will have a different effect around the world.

To read Gareth MacDonald’s recent article on BioPharma, click here. To view a past discussion about this debate on businessinsider.com, click here.