• FDA Guidance Clarifies Intent of Bioterrorism Law Affecting Dietary Supplements

    The US Food and Drug Administration (FDA) has released a new guidance document intended to clarify elements of a 2002 law passed in the hopes of better allowing the agency to deal with bioterrorism concerns. Background The Public Health Security and Bioterrorism Preparedness and Response Act (PHSBPR) of 2002 was passed months after a series of terror attacks hit the US in 2001. While airborne attacks on the World Trade Center buildings and the Pentagon are almost un...
  • FDA Guidance Sets up User Fee System for Pharmaceutical Compounders

    The US Food and Drug Administration (FDA) has published a new guidance document intended to establish user fees to fund its inspections of a new category of compounding pharmacy established under the Drug Quality and Security Act (DQSA) of 2013. Background In late 2012, a massive outbreak of fungal meningitis was traced to deficient manufacturing at a Massachusetts compounding pharmacy. In the wake of the outbreak, which killed more than 60 and left hundreds more inju...
  • FDA Finalizes Massive Rewrite of Device Pre-Submission Guidance

    US Food and Drug Administration (FDA) officials on Tuesday released an extensive guidance document aimed at clarifying elements of the medical device pre-submission program, now used to provide manufacturers and application sponsors with feedback and advice. Those meetings are crucial to identifying, clarifying and mitigating any issues with a clinical trial or full medical device application, which can be delayed or derailed entirely by regulatory issues. The meetings, ...
  • FDA Considers Modernization of Facility Inspection Technologies

    The US Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is calling for private-sector assistance in the development of new regulatory tools that the agency hopes will allow it to evaluate drug manufacturing facilities' risk factors in real time, allowing it to better set priorities for inspection purposes and evaluate data more fully. Background CDER is in charge of regulating the pharmaceutical industry for FDA, and its oversight in...
  • FDA Sets Facility Registration Fees for Manufacturers of Generic APIs, Finished Dosage Forms

    • 16 January 2013
    The US Food and Drug Administration (FDA) has published the user fee rates for facilities that manufacture active pharmaceutical ingredients (APIs) and finished dosage forms (FDF) for the current fiscal year, part of the agency's new authority under the FDA Safety and Innovation Act (FDASIA) . In July 2012, FDA was for the first time given the authority to collect user fees from facilities and manufacturers of generic drug products, including those making just the act...
  • In Unusual Move, FDA Withdraws OMB Submission to Focus on Changes to Device Program

    If you're waiting for the US Food and Drug Administration's (FDA) guidance on planned changes to its medical device pre-submission meeting program, you may have to wait a bit longer. In a highly unusual Federal Register notice on 4 January 2013, FDA explained that it was withdrawing an earlier 11 December 2012 Federal Register notice in which it announced that it had submitted for review the guidance document The Pre-Submission Program and Meetings with FDA Staff ...
  • FDA Gives More Time to Generic Facilities to Register, Saying Many Have Not

    The US Food and Drug Administration (FDA) is delaying by two weeks the implementation of its facility registration requirements under the Generic Drug User Fee Act (GDUFA) , a subset of a recently passed FDA Safety and Innovation Act (FDASIA) . One of the law's main goals was to achieve parity between the way FDA collects fees from branded and generic pharmaceutical products. Under a long-standing program, FDA assesses user fees from branded pharmaceutical companies ...
  • New Facility Registration Requirements Come into Effect for Supplement Manufacturers

    A new guidance for industry published by the US Food and Drug Administration (FDA) includes information about new registration requirements established under the Food Safety Modernization Act (FSMA) , including for dietary supplement manufacturers. The requirements of FSMA came into effect on 22 October and mandate that all food production facilities-of which supplement manufacturers are by definition a part-register with FDA to mitigate the impact of any potential ...
  • Survey: FDA 510(k) Submissions Garner Most Concern Among Device Professionals

    A new survey of medical device professionals conducted by the publication Medical Device and Diagnostic Industry found that 510(k) submissions garner the most concern among all regulatory issues, followed closely by the pre-submission process to the US Food and Drug Administration (FDA). The survey of 283 medical device professionals asked what two regulations and regulatory processes were of the most concern. Thirty-six percent of respondents indicated 510(k) submi...
  • FDA Calls for Comments on Adverse Event Reporting for Medical Devices

    The US Food and Drug Administration (FDA) is calling for medical device manufacturers, importers and facility owners to provide feedback on how FDA collects information related to reports of serious adverse events-or potential events-related to medical devices. The collection of this information is currently mandated under §519(a)(1) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , which says that "whenever the manufacturer or importer receives or othe...