• Regulatory NewsRegulatory News

    FDA Issues 8 Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

    The US Food and Drug Administration (FDA) has issued seven new or updated guidances offering advice to medical device makers on its user fee programs and how FDA and industry actions impact the performance goals set by the fourth iteration of the Medical Device User Fee Amendments (MDUFA IV). In its MDUFA IV commitments, FDA agreed to tighter timelines to reach decisions for most medical device submissions in exchange for increased user fees and the introduction of a n...
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    Does FDARA Open the Door to Third-Party Reviews of Implantable Devices? Lawyer Discusses

    Thanks to the new user fee legislation known as the FDA Reauthorization Act (FDARA), the Food, Drugs and Cosmetics Act (FDCA) has been amended to allow for third-party reviews of Class II devices intended to be permanently implantable, life-sustaining or life-supporting. But which devices will be allowed such third-party reviews and what will be the implications? That decision will come from FDA, which has to issue guidance on the topic sometime in the next two ...
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    FDA, HHS Finalize Guidance on Documenting IRB Activities

    The US Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) on Monday finalized a 2015 draft guidance on how to document institutional review board (IRB) activities. The guidance, developed jointly by the two agencies, details how and what IRBs should document in the meeting minutes they are required to keep under 45 CFR 46.115(a)(2) and 21 CFR 56.115(a)(2), which include: Attendance at the me...
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    Conducting a Successful Advertising and Promotion Review of Restricted Medical Devices

    This article provides insight for regulatory professionals regarding developing a successful advertising and promotional review of restricted medical devices. It demonstrates how medical device manufacturers and pharmaceutical companies can improve communication and collaboration between regulatory and marketing to streamline and improve the compliance review process for promotional materials and achieve an effective marketing strategy. The Dance "How small can I make...
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    Drug Reimbursement in Canada

    This article provides a high-level overview of the elements of prescription drug reimbursement in Canada and discusses the costs, processes and reimbursement plans associated with a number of federal health agencies and payers and describes some of the variety of drug plans in place. The Regulatory–Reimbursement Interface Community (out-patient) drug reimbursement is usually considered after a drug has received regulatory approval from Health Canada. Regulatory proces...
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    How the Government Will Pay Companies to Develop Biodefense Products and Win Lucrative PRVs

    As the nearly 1,000-page 21st Century Cures Act is implemented in phases, the full impact of the law is just beginning to be realized, and for one provision, the law has created a new program that rewards companies for developing products that the government purchases and often pays to develop. Background Under section 3086 of the Cures Act , the US Food and Drug Administration (FDA) must establish a new priority review voucher (PRV) program for material th...
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    Do Drugs Approved Via Expedited Pathways Offer Greater Benefits? Study and Doctors Debate

    A recent study in Health Affairs suggests that drugs given an expedited review by the US Food and Drug Administration (FDA) offer greater health gains than drugs that receiving a conventional review. But experts caution that the study might only show incremental benefits. The study, conducted by Peter Neumann, director of the Center for the Evaluation of Value and Risk in Health and three of his colleagues at Tufts Medical Center, compared the change in quality-adjuste...
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    Asia Regulatory Roundup: Australia Opens Priority Review Pathway (27 June 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Starts Accepting Priority Review Notifications, Implements Revised Orphan Drug Program The Therapeutic Goods Administration (TGA) of Australia has opened its priority review pathway. TGA is now accepting notifications from sponsors who plan to apply for priority review status to accelerate the approval of their medicines in the coming months. Officials at TGA are ...
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    FDA to Speed Reviews of More Generic Drugs, Offers Lists of Those With No Competition

    The US Food and Drug Administration (FDA) took major steps toward increasing generic drug competition on Tuesday by releasing a list of off-patent pharmaceuticals with limited or no competition, and by prioritizing the review of abbreviated new drug applications (ANDAs) for which there are fewer than three ANDAs approved for the reference listed drug. Both moves seek to increase generic drug competition and lower the cost of pharmaceuticals in the US. The generic dr...
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    FDA Approves First Treatment for a Form of Batten Disease

    The US Food and Drug Administration (FDA) on Thursday approved the first-ever treatment for a form of the rare pediatric Batten disease, bringing Biomarin its second lucrative priority review voucher (PRV). FDA approved Brineura (cerliponase alfa) to slow the loss of walking ability in symptomatic pediatric patients three years old and older with late infantile neuronal ceroid lipofuscinosis type 2 (CLN2), also known as tripeptidyl peptidase-1 (TPP1) deficiency. ...
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    Senate, House Draft Reauthorization Bill to Increase Drug, Medical Device User Fees

    With an aim to avoid thousands of US Food and Drug Administration (FDA) employee layoffs, House and Senate committees on Friday released a draft bill to reauthorize the user fee programs for pharmaceuticals, generic drugs, medical devices and biosimilars from 2018 to 2022. Forged via negotiations between FDA and the various industries dating back to 2015, and racing to beat a September deadline, the bills sequentially increase the amount of user fees FDA can assess for r...
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    FDA Officials: Priority Review Drugs Have Higher Likelihood of Getting Boxed Warning After Approval

    A team of officials from the US Food and Drug Administration (FDA) say that drugs approved following a priority review are three-and-a-half times more likely to receive a boxed warning after entering the market. Unlike standard reviews, which can take up to ten months, drugs that treat serious conditions or offer a significant improvement over existing treatments can qualify for a shorter, six-month review. However, the authors note that because drugs given priority rev...