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  • Regulatory NewsRegulatory News

    Final FDA Rule Clarifies Pharma Patent Process With Aim of Reducing Unnecessary Litigation

    With the intent to cut back on the type of litigation that can delay the approval and marketing of generic drugs under 505(b)(2) applications and abbreviated new drug applications (ANDAs), the US Food and Drug Administration (FDA) on Wednesday released a final rule that revises and clarifies its regulations on a number of different parts of the pharmaceutical patent process. The 289-page final rule amends FDA’s regulations to facilitate better compliance with and enforce...
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    Sarepta Wins Controversial FDA Approval for First DMD Drug

    The US Food and Drug Administration (FDA) on Monday approved Sarepta Therapeutics’ first drug to treat patients with Duchenne muscular dystrophy (DMD), a rare genetic disorder that causes progressive muscle deterioration and weakness in young children. The approval is highly controversial after a FDA advisory committee voted against approval in April as the outside experts said there was not substantial evidence that the drug is effective in providing clinical benefit...
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    Japan’s Ministry of Foreign Affairs: Don’t Move EMA Headquarters From London

    If the European Medicines Agency (EMA) transfers its headquarters to another EU member state, which is all but certain following the Brexit vote, Japan’s Ministry of Foreign Affairs is warning that the “appeal of London as an environment for the development of pharmaceuticals would be lost.” The harsh critique comes as the EMA, which has 890 employees of various nationalities at its headquarters in London, has said the decision on where to move from its current locale...
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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 Reiterates Concerns on Citizen Petitions Delaying Drug Approvals

    Although only one abbreviated new drug application (ANDA) and one 505(b)(2) application were delayed in 2015 because of citizen petitions, the US Food and Drug Administration (FDA) has reiterated its concerns that the petitions do not raise valid scientific issues and are only being used to delay the approval of competing products, according to the Thursday release of the FY 2015 report to Congress on approval delays from citizen petitions. In 2015, FDA notes that it ap...
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    Patents vs. Market Exclusivity: Why Does it Take so Long to Bring Generics to Market?

    It’s well known that generic drugs are just as safe and effective as their brand name counterparts. They’re the cheap knockoffs that help more people around the world gain access to innovative and sometimes life-saving treatments; the boring copycats made by companies you’ve never heard of and sold in plain bottles with little fanfare. But what most people, particularly those outside the pharmaceutical industry, don’t realize is that what’s constraining the dissemination...
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    Capsule Supplier Changes: FDA Offers an Updated Policy

    Changing the supplier of gelatin capsules used to encase drugs constitutes a minor change, and does not require a prior approval supplement (PAS), according to a US Food and Drug Administration (FDA) policy that went into effect Monday. Prior Approval Supplement When a drugmaker makes changes to an already approved product, including changes to its specifications, manufacturing process or label, the company must notify FDA of the change. Depending on the seriousness of...
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    FDA Continues Steady Reduction of Generic Drug Application Backlog

    As the debate around high-priced pharmaceuticals and new ways to lower those costs continues, the US Food and Drug Administration (FDA) is speeding the approval of new generic drugs, according to the latest update to the agency’s in-depth look at the backlog of abbreviated new drug applications (ANDAs). The new data (up to 1 July 2016) reveals that FDA has reduced its ANDA workload by about 500 applications in the first six months of 2016 (the ANDA dashboard recapping 2...
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    Physicians Lack Understanding of What ‘Breakthrough’ Designation Means, Study Finds

    A US survey of board-certified internists and specialists revealed “substantial deficits in knowledge” of what it means for a drug to be approved by the US Food and Drug Administration (FDA) and approved via the “breakthrough” pathway, according to a research letter published in JAMA on Tuesday. Since 2012, FDA has designated certain drugs as "breakthrough” therapies (76 drugs have received the designation through April 2015) if preliminary clinical evidence – such as ...
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    FDA Withdraws NDA for Fertility Drug After EMD Serono Fails to Run Postmarket Trial

    More than 10 years since the US Food and Drug Administration (FDA) offered accelerated approval to EMD Serono’s fertility drug Luveris (lutropin alpha for injection), the agency on Monday announced it’s withdrawing the drug’s approval as the company failed to run a postmarketing study required as a condition of approval. First approved on 8 October 2004, Luveris was indicated for concomitant administration with one of EMD Serono’s other fertility treatments, Gonal-F (fol...
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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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    FDA Review Times Steadily Decreasing, Report Finds

    Despite wide variations across therapeutic areas, FDA review times for new drugs have steadily declined since 2009, according to a report released Tuesday by the California Life Sciences Association and Boston Consulting Group. Back in 2009, FDA was averaging 21 months for reviewing new molecular and biologic entities, but five years later, that average has been cut by more than half to nine months in 2014. In addition, the number of applicants waiting more than two year...