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    Drugmakers Split on Whether to Include Interchangeability Statement in Biosimilar Labels

    Drug, biologic and biosimilar companies’ comments on US Food and Drug Administration (FDA) draft guidance on biosimilar labeling reveals a major split between those who do and do not want a statement on a biosimilar’s interchangeability status on each new product's label. The comments come as FDA has still yet to release its guidance on what interchangeability means, and as FDA has not found any biosimilar to be interchangeable with its reference product. However, th...
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    Health Canada Finalizes IVD Labeling Guidance After 18 Years

    The Canadian regulatory agency Health Canada on Friday finalized its guidance for labeling in vitro diagnostic (IVD) devices nearly 18 years after releasing the draft version in 1998. The final guidance includes new considerations for electronic labeling, IVDs with small containers, blood glucose monitors and information on complying with Canada's Official Languages Act , which requires product labels to be written in both French and English. Additionally, the guidance...
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    Updated: Congress Looks to Force FDA Into Rewriting Major Generic Drug Labeling Rule

    As Congress looks to pass a spending bill for FY 2017 by Friday, the House Appropriations Committee has released a new bill with a modest amount of new funding for the US Food and Drug Administration (FDA) and new demands on how FDA should write a controversial and major final rule on generic drug labels. The rule, which FDA has said it will finalize in July , would allow generic drug companies to update their labels with new safety information when that information bec...
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    FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling

    The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product. At the outset of the 15-page guidance, FDA makes clear that biosimilar product labeling should not include a description of a clinical study that merely supports a demons...
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    Asia Regulatory Roundup: Pharmacy Sues CFDA Over Drug Monitoring System (2 February 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. Pharmacy Sues CFDA Over Alibaba Electronic Drug Monitoring System Yontinhe Group has filed a lawsuit against the China Food and Drug Administration (CFDA). The case relates to an electronic drug monitoring system that CFDA introduced in 2013 in collaboration with a subsidiary of the Chinese tech giant Alibaba. CFDA and Ali Health, the Alibaba subsidiary, purportedly ...
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    FDA to Release Major Generic Drug Labeling Rule in July 2016

    The US Food and Drug Administration (FDA) has now said it will release in July a controversial and major final rule that would allow generic drug companies to update their labels with new safety information like their reference product counterparts have done for almost 30 years. Background Under current FDA regulations, generic drug companies with abbreviated new drug applications (ANDAs), unlike companies with new drug applications (NDAs) and biologics license applicat...
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    Health Canada to Require Precautionary Statements in Antimicrobial Labels

    As part of efforts to encourage the more prudent prescribing and use of antimicrobials, Health Canada on Monday announced it will now require the inclusion of precautionary statements in antimicrobial product labelling. The proposal, which was announced alongside the kickoff of World Antibiotic Awareness Week , comes as bacteria are increasingly stronger, more resistant to antibiotics and therefore more lethal. As part of its federal action plan on antimicrobial resis...
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    FDA Amends Liver Warning Labeling Guidance for Some OTC Drugs Containing Acetaminophen

    The US Food and Drug Administration (FDA) on Monday unveiled amended guidance on the liver warnings that must be contained in labels of some over-the-counter (OTC) drugs containing acetaminophen, saying it will allow manufacturers in some cases to warn patients against taking more than 4,000 mg of acetaminophen in 24 hours. The guidance, which was initially issued in 2012 , helps to clarify certain cases where manufacturers of internal analgesic, antipyretic and antirh...
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    FDA to Approve ANDAs on the Basis of Draft Labeling

    The US Food and Drug Administration (FDA) on Monday said via guidance it will approve Abbreviated New Drug Applications (ANDAs) on the basis of draft labeling. The guidance, which FDA is implementing without prior public comment because the agency says it's a "less burdensome policy that is consistent with public health," clarifies that the Office of Generic Drugs (OGD) will no longer require the submission of final printed labeling (FPL) in order to approve an ANDA. Th...
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    Stronger Warnings on 18 NSAIDs After Review Finds Increased Cardiovascular Risk

    The US Food and Drug Administration (FDA) will soon ask drugmakers to update the labels for all non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) after reviewing mounting evidence linking the drugs to increased risk for heart attack and stroke. In total, drugs containing any of 18 listed active ingredients will be affected by the labeling change, including common over-the-counter (OTC) products such as Advil, Motrin and Aleve, as well as prescription drugs such a...
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    Legislators Press FDA to Add Black Box Warning to Immediate-Release Opioids

    A group of nearly two dozen Democratic legislators is calling on the US Food and Drug Administration (FDA) to label immediate-release opioids with more serious warnings meant to reflect "the serious risks of abuse" associated with the drug. In a letter sent on 4 June 2015 to FDA Acting Commissioner Stephen Ostroff, the legislators said their concerns are driven by "the national public health crisis of prescription drug overdoses." Opioid-related overdoses and deaths have...
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    In Petition to FDA, AbbVie Argues Biosimilars Need Distinctive Labeling

    "Biosimilars are not generic drugs and should not be labeled like generic drugs," US pharmaceutical giant AbbVie argues in a new Citizen Petition sent to the US Food and Drug Administration (FDA) this week. The petition focuses on the labeling requirements for biosimilar products under the 2010 Patient Protection and Affordable Care Act (PPACA) , otherwise known as Obamacare. The law established for the first time an approval pathway—the 351(k) pathway—for biosimilar dr...