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    Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

    As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000. For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016 . For an NDA not requiring clinical data or a ...
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    Obama Signs Chemical Safety Bill Into Law

    President Barack Obama on Wednesday signed into law a bill that will overhaul, for the first time in 40 years, the way chemical substances are regulated in the US. Although the new law, which updates the Toxic Substances Control Act of 1976, deals with regulations governed by the Environmental Protection Agency (EPA) rather than the US Food and Drug Administration (FDA), it integrates principles to replace and reduce animal-based tests with human-relevant methods to asse...
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    EU Council and Parliamentary Committees Sign Off on New Medical Device, IVD Regulations

    The European Council's Permanent Representatives Committee and the European Parliament’s Environment and Health Committee on Wednesday endorsed the agreement reached on the continent’s new medical device and  in vitro diagnostic (IVD) regulations, a day after the draft versions of the texts were released. Following a legal-linguistic review of the two documents planned for September, the Council and Parliament could adopt the two draft regulations by the end of 2...
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    8 Pieces of Advice for New Regulatory Professionals

    The sheer volume of laws, regulations and guidance documents covering medicines and medical technology means new regulatory professionals have a lot to learn. Even those who have regulatory experience may find themselves behind a steep learning curve when taking on new responsibilities or switching jobs. What should new regulatory professionals or those changing product lines or industries do to position themselves for success? David Chadwick, PhD, RAC, FRAPS, who is ...
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    House Looks to Reform Tropical Disease Priority Review Voucher Program

    The House Energy and Commerce Committee on Wednesday passed by voice vote an amendment (to an unrelated bill on hospital preparedness for dangerous threats) that would significantly change the priority review voucher (PRV) program for tropical diseases. Background Since 2009, the US Food and Drug Administration (FDA) has issued nine PRVs to reward companies for developing new drugs to treat rare pediatric and tropical diseases with a voucher that can be sold on the op...
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    Asia Regulatory Roundup: CFDA Releases New Guidance on Device Trial Inspections (24 May 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Releases Clutch of Draft Medical Device Clinical Trial Texts China Food and Drug Administration (CFDA) has released a handful of draft documents about clinical trials of medical devices. The documents, which detail the process for on-site inspections and the products that are exempt from studies, continue the ongoing overhaul of the regulation of medical devices in Chi...
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    New Zealand to Overhaul Regulatory System, Will Rely on Other Regulators' Approval of 'Cutting Edge' Products

    The government of New Zealand is working to completely overhaul its regulatory system for healthcare products by drafting new legislation to replace the country's Medicines Act of 1981 . The major changes being proposed are intended to modernize New Zealand's regulatory system by making it more flexible and efficient, while filling in "significant gaps in coverage" for medical devices and cell and tissue therapies. The plan would also allow New Zealand to recognize the...
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    EMA's 2015 Annual Report: Interest in Scientific Advice Increasing

    The European Medicines Agency (EMA) on Tuesday released its Annual Report 2015 touting its performance and key achievements for the year. According to Sir Kent Woods, former chair of the EMA Management Board, 2015 was a year of transition for the agency. In November 2014, EMA Executive Director Guido Rasi's appointment was annulled , leaving the agency without a head until November of the following year when Rasi was re-appointed . Despite the disruption to EMA's le...
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    Drug Safety Reports Still Uninformative, FDA Officials Say

    Most expedited safety reports for investigational new drugs (INDs) are uninformative, despite recent efforts to improve the quality of such reports, FDA officials wrote in a recent research article. Sponsors are required to compile all adverse events for drugs they are studying in annual safety reports. If an adverse event is serious, unexpected or suspected to be caused by the drug being studied, sponsors are required to submit an expedited report to FDA within 15 days ...
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    FDA Proposes New Databases to Monitor CAR T-Cell Safety Across INDs

    The US Food and Drug Administration (FDA) wants to create two new databases that will allow it to look at safety and manufacturing information across multiple applications for products within a promising class of cancer immunotherapies called anti-CD19 CAR modified T-cells. FDA officials presented their proposal to pilot the databases last week during a meeting of the Recombinant DNA Advisory Committee (RAC), which is organized by the National Institutes of Health's (NIH...
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    MDUFA IV: Industry, FDA Iron Out Specifics of $500M Deal

    Industry representatives and the US Food and Drug Administration (FDA) met twice in late January to continue hashing out what will be included in the fourth reauthorization of the Medical Device User Fee Act (MDUFA). In the 27 January meeting, FDA estimated that the additional resources to implement such proposals over the five-year authorization period of MDUFA IV would total $500 million, without inflationary adjustments, and in addition to the base amount of user fees...
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    First-in-Class, Rare Disease Drug Approvals Dominated in 2015: A Breakdown from FDA

    Last year was a banner year for the US Food and Drug Administration (FDA) in terms of new drug approvals, with many of the new drugs coming to market to help rare disease patients and offer new first-in-class options. The total of 45 approvals was well ahead of FDA’s average of about 28 novel approvals between 2006 and 2014, and 36% of those new approvals were for first-in-class drugs while almost half (47%) were to treat rare diseases, or ailments that impact 200,000 or...