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  • Regulatory NewsRegulatory News

    FDA Drafts Guidance on Controlled Correspondence Under GDUFA II

    The US Food and Drug Administration (FDA) on Thursday released draft guidance on the agency’s new commitments related to controlled correspondence under the recently reauthorized Generic Drug User Fee Amendments (GDUFA II). When finalized, the 20-page guidance will replace guidance from September 2015 from GDUFA I. The GDUFA II commitment letter defines complex controlled correspondence as correspondence related to: Evaluation of clinical content Review of bioe...
  • Regulatory NewsRegulatory News

    FDA Considers WHO Scheduling Change for 17 Drug Substances

    The US Food and Drug Administration (FDA) on Friday sought public comments to help prepare a response to the World Health Organization (WHO) regarding the abuse liability and diversion of 17 drug substances, many of which are opioids and similar to fentanyl. WHO will consider whether to recommend certain international restrictions be placed on the drugs. Background Section 201 of the Controlled Substances Act (CSA) provides that when WHO notifies the US under Art...
  • Regulatory NewsRegulatory News

    Former CDC Director: Medicine Should Look Beyond Randomized Controlled Trials

    In an article in the New England Journal of Medicine on Thursday, former director of the US Centers for Disease Control and Prevention Thomas Frieden calls for greater use of alternative data sources, other than randomized controlled trials (RCTs), for health care decision making. "For much, and perhaps most, of modern medical practice, RCT-based data are lacking and no RCT is being planned or is likely to be completed to provide evidence for action. This 'dark matter'...
  • Feature ArticlesFeature Articles

    EU and US Regulations for Chemical Components in Medical Devices

    This article discusses a number of regulations directed at the use of chemical components in medical devices, both in the EU and US. The author reviews legislation, offers compliance advice and warns about the penalties of noncompliance. Introduction When a healthcare provider purchases a new medical product, the purchaser has the same high expectations for long-term reliability and performance that any business has when investing in new equipment. While consumer elec...
  • Regulatory NewsRegulatory News

    When Does CDER Consult With Controlled Substance Staff? Revised MAPP Explains

    The US Food and Drug Administration (FDA) on Monday released a manual of policies and procedures (MAPP) outlining how its Center for Drug Evaluation and Research (CDER) staff consult with Controlled Substance Staff (CSS) on abuse potential and dependence liability. Since 2000, CDER and CSS, which fulfills a unique role within FDA under the authority of the Controlled Substances Act (CSA) of 1970, have collaborated to evaluate all new drug applications (NDAs), abbrevia...
  • Regulatory NewsRegulatory News

    Updated: FDA and EMA in 2016: A Look at the Numbers

    The US Food and Drug Administration (FDA) wasn't the only major regulator to OK fewer new drugs in 2016 than in recent years. Across the Atlantic, the European Medicines Agency (EMA) saw a similar decline in the number of drugs, with only 27 new active substances (NASs) recommended. In fact, both regulators saw the lowest number of new drugs given a positive review in their respective jurisdictions in years. For EMA, the number represents the fewest NASs recommended in a...
  • Regulatory NewsRegulatory News

    FDA Seeks Comment on WHO Recommendations Restricting Certain Psychotropic Substances

    The Food and Drug Administration (FDA) on Tuesday offered a chance for those interested to submit written comments or request an informal public meeting on recommendations by the World Health Organization (WHO) to impose international manufacturing and distributing restrictions on certain drug substances. The comments received will be considered in preparing the US position on these proposals for a meeting of the UN Commission on Narcotic Drugs (CND) in Vienna, Austria,...
  • Regulatory NewsRegulatory News

    FDA Proposes New Rule on Bulk Substances Used to Compound Drugs

    The US Food and Drug Administration (FDA) on Thursday issued a proposed rule that looks to add six bulk drug substances to a list of such substances that can be used in compounding and to remove four other bulk drug substances that FDA evaluated and should not be included in the list. If the proposed rule is finalized, the six bulk drug substances proposed for inclusion will be the first to be included on what’s known as the 503A bulks list. FDA’s Pharmacy Compoundi...
  • Regulatory NewsRegulatory News

    When can Non-Inferiority Trials Establish Efficacy? FDA Explains With Guidance

    The US Food and Drug Administration (FDA) on Monday finalized guidance to pharmaceutical and biotech sponsors looking for more advice on when non-inferiority studies demonstrating effectiveness of an investigational drug can provide interpretable results, how to choose the non-inferiority margin and how to test the non-inferiority hypothesis. The 56-page guidance, which finalizes a draft from 2010 and supersedes the 2010 guidance known as "Antibacterial Drug Products: U...
  • Regulatory NewsRegulatory News

    Asia Regulatory Roundup: TGA Offers Guidance on High-Risk IVD Online Applications (13 September 2016)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Posts Guide to Online Application Form for High-Risk IVDs TGA has released a guide to using its online application form for Class 4 in-house in vitro diagnostic (IVD) devices. In keeping with recent guides created by TGA, the IVD document is a comprehensive walkthrough of the process of applying online for devices that fall into the highest-risk category. Class 4 IV...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    New Law Redefines When Controlled Substances are Officially Approved

    Just before the Thanksgiving holiday weekend, President Barack Obama signed a new law that will effectively provide the pharmaceutical industry with more certainty on when controlled substances are officially approved. The new law, known as the Improving Regulatory Transparency for New Medical Therapies Act, sets new deadlines for the US Drug Enforcement Administration (DEA) to schedule controlled substances, like opioids and other drugs that have the potential to be abu...