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  • Regulatory NewsRegulatory News

    FDA to Prioritize Generic Drug Applications for ‘Sole-Source’ Products

    The US Food and Drug Administration (FDA) on Friday announced it will begin prioritizing abbreviated new drug applications (ANDAs) for generic submissions for which there is currently only one manufacturer. The change, which would effectively speed up the review of so-called "sole-source" generic drugs could increase competition, help with drug shortages and may even drive down the cost of expensive generics that have no competition. The change came in the form of an upd...
  • Regulatory NewsRegulatory News

    Senate HELP Advances Bill to Reauthorize Pediatric PRV Program and Six Other Bills

    The Senate Health, Education, Labor & Pensions committee on Wednesday advanced seven bills, including one that would reauthorize the rare pediatric priority review voucher (PRV) program through 2022, and one bill that would add the Zika virus to the tropical disease PRV program. The advancement of the bill sponsored by Sen. Bob Casey (D-PA) to extend the pediatric PRV program comes as the US Food and Drug Administration (FDA) told the Government Accountability Office ...
  • Regulatory NewsRegulatory News

    More Competition: Senator Proposes Priority Reviews for Some Generics, New Voucher Program

    In looking for ways to create more competition in the US pharmaceutical industry and drive down rising prices, a new Senate bill proposes to prioritize certain generic drug applications and to create a priority review voucher program to incentivize the development of new generics. Sen. Susan Collins’ (R-ME) bill, known as “A bill to increase competition in the pharmaceutical industry,” would amend the Federal Food, Drug, and Cosmetic Act to require the US Food and Drug A...
  • Regulatory NewsRegulatory News

    FDA Calls for End to Priority Review Vouchers as GAO Says Too Early to Gauge Effectiveness

    The US Government Accountability Office (GAO) said Wednesday in a new report that it’s still too early to assess whether the Food and Drug Administration’s (FDA) three-year-old pediatric priority review voucher (PRV) program has stimulated the development of drugs to treat or prevent rare pediatric diseases. The PRV program offers vouchers that companies can win for gaining approval of new rare pediatric treatments affecting fewer than 200,000 people, more than half o...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: CFDA Builds Priority Review Pathway for Drug Approvals (1 March 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. CFDA Creates Priority Review Pathway for Cancer, Rare Disease Drugs The China Food and Drug Administration (CFDA) is creating a priority review pathway to cut the time it takes for some drugs to come to market. CFDA is aiming the initiative at products to treat certain significant illnesses and those that use advanced technology to deliver clear therapeutic benefits. In th...
  • Regulatory NewsRegulatory News

    FDA Looks to Bring Payers to the Table at Device Pre-submission Meetings

    The US Food and Drug Administration (FDA) is calling on private health insurers and other payer groups that use clinical data to inform coverage decisions to participate in medical device pre-submission meetings to facilitate timelier access to new devices. The agency believes that including coverage organizations, such as private insurers and health technology assessment (HTA) bodies, early on will allow those organizations to discuss clinical trial design and evidence ...
  • Regulatory NewsRegulatory News

    Sanofi Redeems $245M Priority Review Voucher for Type 2 Diabetes Treatment

    The US Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for Sanofi’s investigational type 2 diabetes treatment on Monday and granted the use of another Priority Review Voucher (PRV), which speeds up FDA’s decision by four months. In redeeming the voucher, Sanofi had to pay a $2.7 million fee in addition to the standard new drug filing fee of $2.4 million. Retrophin sold the PRV to Sanofi last May for one of the highest amounts eve...
  • Regulatory NewsRegulatory News

    Congress Considers Priority Review Vouchers for Medical Countermeasures

    Members of the House Energy and Commerce Oversight and Investigations subcommittee were briefed on recommendations at a hearing Friday for improving the nation's biodefence strategy against natural and man-made threats. The recommendations are particularly timely as legislators and public health officials scramble to mount a response to the Zika virus outbreak across Latin America and the Caribbean. Many of these recommendations come from the Blue Ribbon Study Panel on ...
  • Feature ArticlesFeature Articles

    Fundamentals and Global Impact of 510(k) for Medical Devices

    This article presents an overview of the fundamentals of 510(k) submissions, including the impact of the unique regulations to US and foreign device manufacturers. Introduction The expansion of the global medical device healthcare market has been evolving rapidly in the 21st century Notably, clinical chemistry analyzers and in vitro diagnostics are estimated to reach $11.7 billion and $75.1 billion respectively by 2019 and 2020. 1, 2 Despite attractive opportunitie...
  • Regulatory NewsRegulatory News

    Generic Drug Review Dashboard: FDA Offers a First Look

    As Congress continues to push for the US Food and Drug Administration (FDA) to speed the approval of new generic drugs, which could be key for keeping pharmaceutical prices in check, FDA for the first time is offering an in-depth look at where it stands with industry’s abbreviated new drug applications (ANDAs). What’s clear from the new data on 2015 is that FDA continues to seek more information or require companies to correct what’s known as an “easily correctible defic...
  • Regulatory NewsRegulatory News

    US, EU & WHO Launch Efforts to Accelerate Zika R&D

    One week after the World Health Organization (WHO) declared a public health emergency in response to Zika-linked clusters of microcephaly, it and authorities in the US and EU are mobilizing to accelerate the development of treatments and diagnostics for the disease. Obama Calls for $1.8 Billion in Funding On Monday, the White House announced it will ask Congress for more than $1.8 billion to establish an emergency fund to combat the Zika virus in the US and abroad. N...
  • Regulatory NewsRegulatory News

    FDA Warns Monmouth Medical Center IRB Over Conflict of Interest Issues

    The US Food and Drug Administration (FDA) on Tuesday released a warning letter to Monmouth Medical Center, a New Jersey hospital, after an inspection of its institutional review board (IRB) found it failed to follow regulations meant to protect clinical trial participants, including for pediatric studies. Specifically, the IRB failed to adequately document whether clinical investigations involving pediatric subjects were in compliance with FDA regulations, or document wh...