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.
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.
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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.
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.
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.
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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.
As FDA begins to build policy and review biosimilar submission packages, the Senate subcommittee on Primary Health and Retirement Security shows some skepticism about the time delay and difficulties that have emerged. Janet Woodcock, director of the Center for Drug Evaluation and Research (CDER), responded by addressing the importance of getting the science right for the release of the first biosimilars. Read her testimony on fda.gov from September 17, 2015 here. When asked about the education of biosimilars to medical professionals, she said that they’ve “laid out a plan of education campaigns and still need to determine what people need to know.” To read more in an article on raps.org, click here.
Since Commissioner Margaret Hamburg resigned in March, it has been speculated that Robert Califf could be the new US FDA commissioner. Califf has been with FDA since February in the role as depute commissioner for medical products and tobacco.
Going forward along with this new change, the Senate is currently working toward legislation to expedite FDA drug approval process. To read Zachary Brennan’s complete article, click here. Also check out the article in Medscape.
FDA has enforced a final rule that allows the destruction of a drug that has been denied entry into the US. The final rule will help control the unwanted drugs that are illegally snuck into the US. Brennan states that the preexisting rule remains the same that the “owner or consignee of a drug valued over the current $2,500 threshold that has been refused admission will still have the option to destroy or export that drug.” The final rule provides additional structure that “for a drug valued at $2,500 or less that has been refused admission, FDA is allowed to destroy the drug without providing the owner or consignee with the opportunity to destroy or export it.”
It is estimated that the final rule will cause approximately 15,100 destructions each year and will save $901,950 annually. The final rule will take effect on October 14th. To learn more, check out Zachary Brennan’s article on RAPS.org.
FDA has updated its guidance on resolving disagreements and disputes between sponsors and the agency. The goal is to avoid messy disputes by holding discussions that will hopefully lead to more timely resolutions. The revisions of the guidance state more appropriate regulatory actions for a formal dispute resolution request (FDRR). To get less people involved, the sponsor must first interact with the deciding official before appealing to higher up management. To read Zachary Brennan’s full article on raps.org, click here.