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    EU’s Pediatric Regulation: European Commission Seeks Feedback for New Report

    The European Commission (EC) on Tuesday launched a public consultation to obtain feedback for its second report on the  Pediatric Regulation,  ten years after its implementation. The comments on the consultation, which is open until 20 February 2017, will help inform the EC's report, which is expected to be published in 2017 and will assess the regulation's impact on public health and the pharmaceutical industry. Background The Pediatric Regulation, known in the EU ...
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    Priority Review Voucher Fees to Decline in FY 2017

    The US Food and Drug Administration (FDA) on Thursday unveiled the new user fee rates for the tropical disease and rare pediatric disease priority review voucher (PRV) programs. The additional fees necessary to use the vouchers for both programs are set to decline by about $20,000 when compared to last year. Tropical Disease Priority Review Voucher User Fee Year Voucher Fee FY 2011 $4,582,000 FY 2012 $5,280,000 FY 2013 $3...
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    Congress Signs Off on Short-Term Extension to Rare Pediatric PRV Program

    The House late Tuesday followed its Senate counterparts and sent to President Barack Obama a re-authorization of the rare pediatric disease priority review voucher (PRV) program that will last through the end of December. A spokeswoman for Sen. Bob Casey (D-PA), a sponsor of the bill, told Focus that between now and 30 December, Congress will discuss ways to amend the program and extend it again. “Our policy changes are in S. 1878, which is headed to the president, so...
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    Pediatric Priority Review Vouchers on the Chopping Block as Reauthorization Stalls

    Congress and President Barack Obama have one week to reauthorize the rare pediatric priority review voucher (PRV) program or else it will end on 30 September 2016, after seven pediatric PRVs have been awarded, one of which sold for $350 million last year. The PRV program offers vouchers that companies can win for gaining approval of new rare pediatric treatments, affecting fewer than 200,000 patients under the age of 18. The vouchers can be used to speed FDA’s review ...
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    10 Disruptive Technologies and the Regulatory Implications

    The 2016 Regulatory Convergence will begin with opening keynote remarks from R “Ray” Wang , noted expert on disruptive technologies and new business models . Hearing Wang’s thoughts on innovation and technology and how regulatory can keep up with the rapid changes should prove to be a timely and appropriate way to begin this year’s Convergence. The healthcare products sector has seen the introduction and development of a number of disruptive technologies in ...
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    FDA Warns 14 International Medical Device Companies

    The US Food and Drug Administration (FDA) has released a slew of warning letters—14 in total—sent from the Center for Devices and Radiological Health's (CDRH) Office of Compliance to five device manufacturers located in the UK, three in China, two in Germany, and one each in Argentina, France, Italy and the Philippines. By far the most common issues cited by FDA were: Number of Citations Issue 11 Failure to establish and maintain adequate procedures for imple...
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    FDA Declares ‘General Wellness’ Devices Exempt From Regulations

    The US Food and Drug Administration (FDA) on Thursday finalized guidance saying that it does not plan to review low-risk "general wellness products", such as wearable fitness monitors or sleep trackers and will not require them to comply with premarket and postmarket regulatory requirements. Under the guidance, such products are exempt as long as they "are intended for only general wellness use…and present a low risk to the safety of users and other persons." As in the...
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    EC Report Analyzes Regulatory Frameworks for Advanced Therapies in US, Canada, Japan and Korea

    The European Commission report released Wednesday dissects the similarities in how gene-, cell- and tissue-based advanced therapies are regulated across the four different geographic regions, though ongoing research projects in such therapies are heavily concentrated in the US and Japan. The 327-page report highlights the “high degree of convergence” in the regulation of advanced therapies across the US, Canada, South Korea and Japan, noting that only Japan has enacted (...
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    Brexit Conundrum: How Does MHRA Work With EMA Moving Forward

    With the UK deciding by referendum to leave the EU, the vote will have major implications for the regulation of medicines and medical devices across the entire continent. Not only will the European Medicines Agency (EMA) have to uproot its headquarters from London (presumably shifting more than 600 full-time employees), but the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will have to decide if they want to continue conducting drug manufacturing...
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    FDA Finalizes Guidance on Extrapolating Data for Pediatric Medical Devices

    A little more than a year after introducing the draft version, the US Food and Drug Administration (FDA) on Monday finalized guidance on how and when it may be appropriate to leverage existing clinical data to support pediatric medical device indications and labeling. The guidance, which, like the draft from May 2015 , reveals FDA’s concerns with the paucity of scientific evidence substantiating medical device submissions for pediatric indications, outlines ways in whic...
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    European Commission Unveils Four New Public Consultations on Clinical Trials

    The four new consultations, released Thursday from the European Commission, deal with ethical considerations for pharmaceutical trials with minors, risk proportionate approaches in trials, summaries of trial results for non-specialists or “laypersons” and definitions of investigational medical products (IMPs) and use of auxiliary medicinal products (AMPs). The consultations offer respondents a chance to weigh in (comments on the four consultations are due by 31 August) o...
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    Industry Questions FDA Study on Efficacy Claims in DTC Pharma Ads

    Pharmaceutical companies AbbVie, Eli Lilly and Merck are raising new questions about the Food and Drug Administration’s (FDA) plan to investigate the impact on consumer perceptions of prescription drugs if efficacy claims are included in the advertisements. The Office of Prescription Drug Promotion’s (OPDP) study of direct-to-consumer (DTC) print advertising of drugs, first announced in July 2015 , will also seek to better understand if consumers make different cho...