– FDA’s Physical-Chemical Identifier Guidance and 1-1 Interaction Will Guide Use of SigNature® Platform in Counterfeit-Risk Mitigation, Brand/IP Protection and Supply Chain Security –
STONY BROOK, N.Y.–(BUSINESS WIRE)–#moleculartagging–Applied DNA Sciences Inc. (NASDAQ: APDN) (“Applied DNA” or the “Company”) today announced that the Emerging Technology Team (ETT) of the U.S. Food and Drug Administration (FDA) has accepted the Company into its Emerging Technology Program (ETP) for the molecular tagging of Solid Oral Dosage Forms (SODF). The ETP serves to help promote the adoption of innovative approaches to pharmaceutical product design and manufacturing and offers technology companies and their pharmaceutical customers the opportunity to discuss, identify, and resolve potential technical and regulatory pathways early in the development and implementation of novel technology.
ETP also affords FDA the opportunity to become familiar with new technologies prior to regulatory submissions. From the ETT’s home within the Center for Drug Evaluation and Research (CDER), it can offer reach into various FDA groups to support programs which may straddle responsible organizations such as with the Center for Biologics Evaluation and Research (CBER). Applied DNA follows into the ETP other industry-leading technology companies who have navigated the simultaneous challenges of compliance and new process innovation such as the first 3D-printing of drug tablets, transforming from batch to continuous processes for manufacturing, and the use of IoT in controlling manufacturing quality.
Applicants to the program are evaluated by FDA on whether the proposed technology has the potential to improve product safety, identity, strength, quality, or purity, or includes one or more elements of quality management (e.g., product design, manufacturing process, testing or process controls) for which the agency has limited review or inspection experience. The ETT promotes early engagement, face-to-face meetings, site visits and pre-approval inspections. Members of the ETT engaged with Applied DNA are likely to participate with the Company throughout the entire development of a customer’s molecular tagging program.
“With the overwhelming majority of domestic drug production reliant on the importation of active pharmaceutical ingredients from overseas sources, there is an underappreciated and pressing need for product security across global pharmaceutical supply chains,” stated Dr. James Hayward, president and CEO of Applied DNA. “We are already aligned with partners that offer us a path to drive industry adoption of our authentication technologies and mitigate participation of counterfeit and adulterated drugs in the legitimate pharmaceutical supply chain, such as, Colorcon, a leader in the development, supply and support of formulated products for the pharmaceutical industry; Videojet, a world-leader in the inkjet printing market; and Schreiner Group, specializing in innovative, functional labels and integrated security solutions across many industries, including the pharmaceutical industry.”
Judy Murrah, Chief Information Officer of Applied DNA., said, “Applied DNA’s authentication technology is a robust, multi-layered platform that complements FDA’s Drug Quality and Supply Chain Security Act serialization initiative. The introduction of an immutable identity for traceability and authenticity to both the dose and the packaging supports product investigations even when the two become separated. It is potentially a game-changer for the pharmaceutical industry. Such forensic data has been used as evidence in European courts to support the conviction of 138 criminals, setting the table in the pharmaceutical industry as support for investigations of product liability, counterfeiting and diversion.”
About Applied DNA Sciences, Inc.
Applied DNA is a provider of molecular technologies that enable supply chain security, anti-counterfeiting and anti-theft technology, product genotyping, diagnostics and pre-clinical nucleic acid-based therapeutic drug candidates.
LinearDNA™ is a trademark of Applied DNA Sciences, Inc.
The Company’s common stock is listed on NASDAQ under ticker symbol ‘APDN’, and its publicly traded warrants are listed on OTC under ticker symbol ‘APPDW’.
The statements made by Applied DNA in this press release may be “forward-looking” in nature within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. Forward-looking statements describe Applied DNA’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of Applied DNA. Actual results could differ materially from those projected due to the possibility of a failure to make timely payment on its outstanding secured convertible notes and resulting enforcement by noteholders of remedies on collateral which includes substantially all of Applied DNA’s assets, its history of net losses, limited financial resources, limited market acceptance, the uncertainties inherent in research and development, future clinical data and analysis, including whether any of Applied DNA’s or its partners diagnostic or therapeutic candidates will advance further in the preclinical research or clinical trial process, including receiving clearance from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies to conduct clinical trials and whether and when, if at all, they will receive final approval from the U.S. FDA or equivalent foreign regulatory agencies, the unknown outcome of any applications to U.S. FDA or equivalent foreign regulatory agencies and various other factors detailed from time to time in Applied DNA’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 12, 2019 and our subsequent quarterly report on Form 10-Q filed on February 6, 2020, and other reports we file with the SEC, which are available at www.sec.gov. Applied DNA undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, unless otherwise required by law.
investor contact: Sanjay M. Hurry, LHA Investor Relations, 212-838-3777, email@example.com
program contact: Judy Murrah, Chief Information Officer, Applied DNA, 631-240-8819, firstname.lastname@example.org
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