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  • Regulatory NewsRegulatory News

    Do FDA’s Foreign Offices Help Keep US Drugs Safe? GAO Says Answer is Unknown

    A new Government Accountability Office (GAO) report offers some good news and some bad news for the US Food and Drug Administration’s (FDA) foreign offices: The good news is that foreign inspections of drug, medical device and food manufacturing sites are increasing year over year, but the bad news is that FDA has yet to determine whether these foreign offices meaningfully contribute to US drug safety. Back in 2008, FDA opened its first foreign offices as part of its res...
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    US Supreme Court to Review Biosimilar ‘Patent Dance’

    The US Supreme Court on Friday said that it will review whether biosimilar companies should have to wait six months after US Food and Drug Administration (FDA) approval before launching their follow-on products. The decision will not only have an impact on how biosimilar developer Sandoz and biologics company Amgen move forward in their interpretation of the Biologics Price Competition and Innovation Act of 2009 (BPCIA) but on the US biosimilar industry as a whole. T...
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    GAO: FDA's White Oak Campus Poses Security Risk

    According to a new report from the Government Accountability Office (GAO), parking and cramped offices at the US Food and Drug Administration's (FDA) White Oak campus in Maryland pose a security risk for the agency. In its report, GAO calls on FDA to implement a parking security system in line with the Department of Homeland Security's Interagency Security Committee standards for high risk facilities. The report also calls on the agency to work with the General Services ...
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    Asia Regulatory Roundup: India Adopts Risk-Based Approach to Biologic Licenses (20 December 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Adopts Risk-Based Approach to Biologic Licenses, Ending Mandatory Inspections The Drug Controller General of India (DCGI) has scrapped the need for manufacturers to undergo a joint inspection before receiving certain biologics licenses. Instead of conducting pre-approval visits, Indian regulators will award Form 29 licenses within three days of receiving applications ...
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    EU Pharma Patent Settlements Still Limiting Entry of Generics

    Almost three-quarters of 125 patent settlements in the EU in 2015 between originator pharmaceutical and their generic competitors resulted in a lengthening of time to bring the cheaper generic version to market. But of those 74%, only 10% were settlements limiting generic market entry and including a payment or transfer of value from originator to generic company, while 64% were settlements limiting generic entry but with no value transfer. The remaining 26% of settlemen...
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    FDA’s Office of New Drugs Director to Retire

    After nearly 25 years of service at the US Food and Drug Administration (FDA), John Jenkins , M.D., Director of the Office of New Drugs (OND), will retire from the federal government on 6 January 2017. For the past 15 years, Jenkins has led OND in its difficult tasks of setting US standards for new drugs’ safety and efficacy, overseeing the clinical testing of investigational drugs and reviewing marketing applications under Prescription Drug User Fee Act (PDUFA) time...
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    GAO Report Highlights Ongoing Challenges in Oversight of Drug Compounders

    A new report by the Government Accountability Office (GAO) finds that while the US Food and Drug Administration (FDA) has taken steps to improve its oversight of drug compounders, challenges at both the state- and FDA-level remain. Background Unlike traditional drugmakers, drug compounders are exempt from certain requirements of the Federal Food, Drug and Cosmetic (FD&C) Act . These exemptions allow compounders operating under section 503A of the act to produce drugs w...
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    Asia Regulatory Roundup: India Looks to Meet WHO Standards for GMPs (11 October 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. India Proposes to Bring GMPs up to WHO Standard, Scrap Need to Renew Licenses The Drug Controller General of India (DCGI) is proposing to bring the country’s good manufacturing practices (GMPs) up to the standard set by the World Health Organization (WHO). DCGI Dr. GN Singh unveiled the proposal alongside plans to end the need for manufacturers, sellers and testers of ...
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    EU Bans Non-Critical, Sterile Products from a Pfizer Site in India Following Joint Inspection

    A statement of noncompliance released by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Friday effectively bans in the EU medicinal products considered non-critical to public health from Pfizer's Irungattukottai, India-based site following an inspection with four regulators. Pfizer decided to temporarily suspend operations at the site earlier this month and MHRA is now calling on EU member states’ National Competent Authorities to evaluate how ...
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    Indian Sites From Pfizer, Wockhardt Face Complications After GMP Inspections

    • 08 August 2016
    Pfizer and Wockhardt are struggling to keep pace with pharmaceutical good manufacturing practice (GMP) regulations as two recent inspections of their manufacturing sites in India resulted in a US ban for Wockhardt and a temporary suspension of the Pfizer site. For Pfizer, the inspection of its Chennai-based site, acquired as part of its $16 billion purchase of Hospira, was a joint effort for officials from four regulators: the US Food and Drug Administration (FDA), UK’s...
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    Brexit Rejig: UK Taps Three Leaders to Helm Office for Life Sciences

    The UK’s Office for Life Sciences, which will continue to be a joint unit across the Department of Health (DH) and the newly formed Department for Business, Energy, and Industrial Strategy (BEIS), on Thursday selected three new ministers to lead. In the DH, two ministers will be jointly responsible for life sciences, including: Lord Prior of Brampton, Parliamentary Under Secretary of State for Health and former adviser to the health authority of Abu Dhabi, who will lea...
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    FDA Unveils IRB Draft Guidance on Written Procedures

    The US Food and Drug Administration (FDA) and the Department of Health and Human Services' (HHS) Office for Human Research Protections (OHRP) have released new draft guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow. IRBs are used to approve and oversee human research in order to ensure that participants are adequately protected. Under federal regulations, IRBs are required to maintain and follow written procedures...