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  • Regulatory NewsRegulatory News

    FDA Finalizes Guidance on Developing DAA Drugs to Treat Hepatitis C

    • 06 November 2017
    The US Food and Drug Administration (FDA) on Monday finalized draft guidance on developing direct-acting antiviral (DAA) drugs to treat Hepatitis C after revising the guidance twice. The guidance addresses nonclinical development, early clinical development and Phase 3 protocol designs, including trial design options, choice of noninferiority margins for active-controlled Phase 3 trials in the evaluation of interferon (IFN)- free regimens, and trial design options ...
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    FDA Seeks Tweaks to Right-to-Try Bill in House E&C Hearing

    The House Energy & Commerce Committee on Tuesday held a hearing to discuss a "Right-to-Try" bill passed in the Senate that the US Food and Drug Administration (FDA) is seeking to change. The hearing discussed a bill that would seek to undercut FDA’s oversight of a program, known as expanded access, whereby terminally ill patients and their doctors can request access to an investigational drug outside of a clinical trial. Right-to-Try laws have now passed in 37 states...
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    Malaysia Issues Compulsory License for Gilead Hepatitis C Drug

    Late last month, Malaysia's government issued a compulsory license in an effort to offer a less-expensive version of Gilead's hepatitis C drug and increase access. Reports of the government move in Malaysia coincided with Gilead's decision on 24 August to extend its voluntary licenses on its hepatitis C medicines to include Malaysia, Ukraine and Belarus. Previously, the company signed agreements with 11 India-based manufacturers to make generics of its hepati...
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    House Subcommittee Advances User Fee Reauthorizations

    Following its Senate counterparts, the Energy & Commerce health subcommittee on Thursday advanced a bill to reauthorize the user fee agreements over the next five years for drugs, generic drugs, medical devices and biosimilars. All four amendments were agreed to, including one to increase generic drug competition and provide 180-day exclusivity for first generics where there’s a limited market, one on protecting the supply chain, one on improving the process for me...
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    House Committee Asks FDA for More Info on Contaminated Heparin Investigations

    Four Republicans on the House Committee on Energy & Commerce sent a letter on Wednesday to US Food and Drug Administration (FDA) acting commissioner Stephen Ostroff seeking additional information on FDA’s investigations into a heparin contamination crisis from a decade ago that are now closed. In 2007 and 2008, heparin sourced from Chinese manufacturers was linked to the deaths of nearly 150 Americans. Questions of contamination resurfaced last year when French regula...
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    FDA Drafts List of Class II Devices to be Exempt From Premarket Notification

    The US Food and Drug Administration (FDA) began implementing the recently passed 21st Century Cures Act on Monday by publishing a draft list of class II devices that will be exempt from premarket notification requirements, or 510(k)s. FDA said in a statement that it “believes that the devices identified in the Federal Register are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safe...
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    FTC: Shire ViroPharma Abused FDA Citizen Petition Process, Delaying Generics

    The US Federal Trade Commission (FTC) on Tuesday filed a complaint against Shire ViroPharma for blocking and delaying the marketing of generic versions of its antibiotic Vancocin (vancomycin), which first won FDA approval in 1986. “Facing the threat of generic competition to its lucrative franchise, ViroPharma inundated the FDA with regulatory and court filings—forty-six in all—to delay the FDA’s approval of generic Vancocin Capsules. That number is, by far, the mo...
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    New House E&C Chairman to Consider Value-Based Drug Price Negotiations

    The newly minted chairman of the influential House Energy & Commerce Committee is looking to tackle pharmaceutical price gouging with a new bill and comments on how there need to be more negotiations to bring down prices. In an interview with The Oregonian this week, Rep. Greg Walden (R-OR), who attended Tuesday’s meeting with President Donald Trump and pharmaceutical CEOs , said: “Right now they're prevented from having those negotiations by law. We would fix that...
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    WHO Prequalifies First Hepatitis C Diagnostic

    The World Health Organization (WHO) on Monday announced it has prequalified its first hepatitis C virus (HCV) rapid diagnostic test, which will help diagnose HCV in low- and middle-income countries and potentially improve access to treatment. The prequalification of South Korea-based Standard Diagnostics’ point-of-care diagnostic, called SD BIOLINE HCV, comes as an increasing number of people in low- and middle-income countries are now gaining access to hepatitis C cure...
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    FDA Finalizes Guidance on Donor Screening to Reduce Hepatitis B Transmission

    The US Food and Drug Administration (FDA) on Wednesday finalized its guidance on reducing the risk of hepatitis B virus (HBV) transmission via human cells, tissues and cellular and tissue-based products (HCT/Ps) by screening donors with nucleic acid tests (NAT). Specifically, FDA says that HCT/P establishments should add nucleic acid tests for HBV to their testing arsenal as the new tests offer significant improvements in how early the virus can be detected. "FDA-licens...
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    European Regulatory Roundup: Advances in Hepatitis C Care Prompt EMA to Revise Guidance (14 July 2016)

    Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news. Fast Advance in Hepatitis C Care Prompts EMA to Revise Clinical Trial Guideline EMA has proposed changes to its guideline on clinical trials of direct acting antiviral hepatitis C drugs. The revisions are intended to ensure the guideline reflects the dramatic changes that have happened in the hepatitis C sector since Gilead introduced its blockbuster Sovaldi (sofosbuvi...
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    Industry, FDA Discuss Benefits of Data Sharing in Biomarker Development

    Data sharing is critical to the validation of new biomarkers used in drug development, experts at the seventh annual Predictive Safety Testing Consortium (PSTC) workshop at the US Food and Drug Administration's (FDA) White Oak campus on Monday said. Biomarkers are biological characteristics that can be measured to give an indication of a biological process or the presence or likelihood of a disease.  They can also predict how a patient might respond to a particular inter...