• Regulatory NewsRegulatory News

    FDA Looks to Decrease Adverse Events With New Home-Use Device Label Database

    As part of efforts to reduce an increasing number of adverse events from home-use medical devices, the US Food and Drug Administration (FDA) is proposing to create an online database of all such device labels and to require companies to submit the labels and package inserts in an electronic format.  The shift comes as FDA reviewers claim that the agency receives reports of approximately three to five of the most serious types of adverse events (deaths, fires, explosions...
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    FDA Amends Definition of Custom Device

    The US Food and Drug Administration (FDA) on Tuesday released a final rule that amends its regulations on the definition of a custom device so as to include new statutory requirements under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). Under the revised provision, as under the original custom device exemption, a device that meets the qualification of a custom device is exemp...
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    Final Rule on Clinical Trial Transparency: Will it be Enough to Encourage More Compliance?

    The National Institutes of Health (NIH) on Friday issued a final rule that its leaders said is expected to result in “rapid increases” in the percentage of trials registered and shared via  ClinicalTrials.gov , though it remains to be seen if the $10,000 per day penalties that can be assessed by the US Food and Drug Administration (FDA) will be strictly enforced. Writing in a JAMA Viewpoint on Friday, NIH Director Francis Collins and other senior leaders said: “Inves...
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    FDA Pushes Back Enforcement of UDI Rule Provisions

    The US Food and Drug Administration (FDA) on Monday finalized guidance that makes clear the agency will not enforce a deadline for certain unique device identifier (UDI) provisions after commenters on the draft guidance said they would not be able to meet the deadline in time. The shift in enforcement comes as FDA says it wants to make sure it gives companies enough time to make changes to the medical device reimbursement, supply chain and procurement systems and proces...
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    Approval of Anthrax Vaccine Under FDA’s Animal Rule is a Step Forward, Researchers Argue

    Although the US Food and Drug Administration’s (FDA) 2015 approval of the vaccine BioThrax for postexposure prophylaxis (PEP) for inhalational anthrax wasn’t the first approval under the rarely used Animal Rule, researchers in Nature explained on Thursday why it is a “significant step forward” in the approval of new vaccines and other medical countermeasures under the pathway. Background The Animal Rule pathway (codified here ) was designed to allow companies to bri...
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    FDA Begins Intercenter Pilot Project on Combination Products

    The US Food and Drug Administration (FDA) announced Monday that it is beginning a new pilot project linked to its intercenter consult request (ICCR) process for combination products of drugs, medical devices and/or biologics. To improve combo product submission review at FDA, the agency is stressing the need for closer intercenter collaboration and communication and is planning to test certain aspects of those collaborations in the pilot, with the goal of achieving imple...
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    Generic Drug Labels: FDA Offers Draft Guidance on Updates After Reference Products are Withdrawn

    The US Food and Drug Administration (FDA) on Friday released draft guidance describing the process for drug companies when they have to update a generic’s label after the reference product (for which the generic is based) is withdrawn for reasons other than safety or effectiveness. The guidance focuses on a problem that has long plagued the generic industry, as generic labels are required by law to mirror their reference product counterparts at the time of approval but s...
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    FDA Issues Final Rule on Symbols for Device Labels

    The US Food and Drug Administration (FDA) on Wednesday issued a final rule to allow for the use of standalone symbols on medical device and in vitro diagnostic (IVD) labels in an effort to align with international standards. In addition to allowing the use of standalone symbols, the final rule also permits the use of the symbol statements "Rx only" and "℞ only" for prescription devices. FDA says the finale rule is optional, though the agency thinks that it will be a b...
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    FDA Kicks Pharma, Device Rule Finalizations Down the Road, Past Obama’s Presidency

    The US federal government is notoriously slow at promulgating new rules and bringing them into enforcement. But the US Food and Drug Administration (FDA) is taking that slowness to a whole new level for a host of potentially controversial final and proposed rules, some of which have lingered for decades. On Friday, the US Department of Health and Human Services (HHS), which FDA operates under, released its semiannual inventory of rulemaking actions under developm...
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    FDA’s Punt on Finalizing the Generic Drug Labeling Rule: Experts Debate

    The US Food and Drug Administration (FDA) again pushed back (from later this summer until April 2017) its finalization of a contentious rule that would allow generic drug companies to update labels like their brand name counterparts. An FDA spokeswoman told Focus that the new date for the finalized rule is a “projected” date “that may be adjusted to reflect ongoing work,” though she could not offer any specifics on why this date was pushed back for this rule. The pro...
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    Three FDA Final Rules Slated for Release in May

    Although the final action dates for the three US Food and Drug Administration (FDA) rules are not set in stone, the agency has said it may finalize new regulations this month, which deal with medical device trial data, postmarket safety reporting requirements for combination products and revised regulations (pending for almost 10 years) on what companies must register establishments and list medical products. Device Trial Data The final rule on medical device clinical s...
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    Market Access in Europe: Bridging Regulatory and Health Technology Assessment (HTA) Gaps

    This article introduces the roles of HTA bodies within the EU member states healthcare system and provides key elements to consider for manufacturers who would like to enter this geographical market. In addition, solutions to maximize the product development strategy are discussed with the intention of bridging regulatory and market access gaps. The rapid diffusion of health technologies has presented governments with unprecedented challenges to provide high quality an...