On September 24, 2013, the Food and Drug Administration (FDA) issued a “final” rule regarding the Unique Device Identification System to adequately identify devices through distribution and use. The FDA has since issued several guidances updating implementation of the unique device identifier (UDI). On November 5, 2018, the FDA issued its latest UDI policy, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” which supersedes the direct marking deadlines mandated by an earlier guidance.
The U.S. Food and Drug Administration recently announced it will withdraw a proposed rule that would have required generic drug manufacturers to independently update their drug labels with new information. The proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, would have imposed on generic drug manufacturers the same labeling-update mandates that now apply only to brand-name drug manufacturers.
The Food and Drug Administration recently issued draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” Comments to this draft guidance should be provided by December 5, 2018.
FDA provides authorization for marketing a device when its benefits outweigh its risks. Uncertainty surrounding these benefits and risks is a factor that FDA considers when making its determination with respect to premarket approval application (PMA) approvals, de novo classifications, 510(k) clearances, humanitarian device exemption (HDE) approvals and investigational device exemption approvals. As it has in previous guidances, FDA attempts to provide “a flexible, patient-centric, benefit-risk approach” that is “tailored to the type and intended use of the device and the type of decision” required. For example, PMA and de novo requests require a demonstration of reasonable assurance of safety and effectiveness. However, HDE applications inherently have a greater uncertainty surrounding the benefit-risk profile as Congress provided that these applications need not show a reasonable assurance of effectiveness as the patient population is generally very small.
Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes certain qualified third parties (3P Review Organizations) to conduct the initial review of premarket notification submissions for certain low-to-moderate risk medical devices. The 3P Review Program has been in existence since 1996, and the Food and Drug Administration (FDA) has modified aspects of the 3P Review Program from time to time to comply with changes in the statutory framework. The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, amended Section 523. In response, the FDA has now published a draft guidance, titled “510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations,” which modifies the 3P Review Program guidance. Comments and suggestions are due by December 13, 2018. When finalized, this guidance will supersede FDA’s guidance documents from 2001 and 2004.
The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.
If you are a university researcher interested in launching a startup based on an invention developed in your lab, below is a list of some key guidelines to keep in mind as you start your company: Continue reading Five Good Habits of University Researchers Launching Spinouts
On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), a combination of a number of previously passed House and Senate bills related to addressing the opioid crisis. One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.
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The 510(k) process provides a review procedure for marketing clearance of devices that are “substantially equivalent” to other approved devices or to a standard recognized by the Food and Drug Administration (FDA).
On September 6, 2018, the FDA launched an alternate to the Traditional 510(k) for submitting a Premarket Notification (510(k)). The FDA calls the alternative the Quality in 510(k) “Quik” Review Program Pilot. Under the program, the FDA’s goal is “to make a final decision within 60 days.”
Among the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the U.S. Food and Drug Administration to gain insight on moving a clinical development program for a proposed biosimilar product forward. Tracking meeting requests is also one way to measure the prospects for growth and health of the U.S. biosimilars industry. By that measure, the prospects for the U.S. biosimilars industry look bullish. This year, FDA revised its estimate for meeting requests upward by six respondents to Center for Drug Evaluation and Research (CDER) meeting requests, reflecting the industry’s confidence in the growth of biosimilar market share in the United States.
FDA’s upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States. In 2014, Rand Corporation estimated biosimilar cost savings over the next decade to be $44 billion. By 2017, Rand Corporation estimated biosimilar cost savings over the next decade to be $54 billion. The increase in estimated cost savings is premised on biosimilars gaining in market share of biologics prescriptions. These signs are all pointing toward increased growth of the U.S. biosimilars industry.
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The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances that would constitute interference with a drug inspection under the Food and Drug Administration Safety and Innovation Act (FDASIA), signed into law on July 9, 2012.
Prior to the passage of the FDASIA, sections 301(e) and 301(f) of the Food, Drug, and Cosmetic Act (FD&C Act) prohibited drug facilities from denying FDA: (1) entry or the opportunity for inspection or; (2) refusing access to or the opportunity to copy specific records. Section 707 of the FDASIA extends this prohibition, through section 501(j) of the FD&C Act, by deeming a drug adulterated if ” … it has been manufactured, processed, packed, or held in any factory, warehouse, or establishment and the owner, operator, or agent of such factory, warehouse, or establishment delays, denies, or limits an inspection, or refuses to permit entry or inspection.” This provision extends to “any factory, warehouse, or establishment in which … drugs … are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such … drugs … in interstate commerce.” FDASIA also adds section 704(a)(4) to the FD&C Act, allowing FDA to “request, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, records or information that FDA may inspect under section 704(a).”
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