• Feature ArticlesFeature Articles

    Subpart H and the implications for ad promo

    Advertising and promotion (ad promo) of prescription drugs is regulated by the US Food and Drug Administration (FDA). In 1992, the agency implemented Subpart H of Title 21 of the Code of Federal Regulations (CFR) to allow for the accelerated approval of new drugs for serious or life-threatening illnesses. Approval of a drug through the Subpart H pathway introduced a range of regulatory requirements, some of which had specific implications for the ad promo of Subpart H drug...
  • Regulatory NewsRegulatory News

    FDA officials impart lessons learned from quality management maturity pilots

    The US Food and Drug Administration’s (FDA) should brief pilot participants ahead of the actual assessments and use a simplified rubric for scoring or rating a manufacturers quality management maturity (QMM) program. These were some of the lessons learned as the agency develops a future rating program for evaluating manufacturers on drug quality, according to results reported in a 10 January article published in The AAPS Journal .   These pilots “afforded FDA the opp...
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    Drug preclusion and public health: The case for a narrow interpretation of ‘article’

    The definition of “dietary supplement” in the Food, Drug, and Cosmetic (FD&C) Act includes several provisions limiting what can be a legal dietary supplement based on the ingredients used and delivery form, as well as whether a substance has a history of drug use. This article explores the US Food and Drug Administration’s (FDA’s) use of this last provision, often called “drug preclusion.” The authors examine the history of the provision, Congress’s purported purpose for ...
  • Regulatory NewsRegulatory News

    ICH M12: Pharma industry wants clarity on rifampin dosing, more information on biomarkers

    The pharmaceutical industry would like the International Council for Harmonization (ICH) to clarify dosing information for rifampin and requests additional information on the use of biomarkers as a type of drug-drug interaction study (DDI), while the Pharmaceutical Research and Manufacturers of America (PhRMA) and Pfizer want more flexibility in developing a DDI strategy.   The comments were made in response to the US Food and Drug Administration’s (FDA) call for feedb...
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    FINALIST Maximizing the potential of the FDA assessment aid: Genentech’s experience

    The assessment aid (AAid), an initiative of the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE), was introduced in 2018 as a pilot program to help streamline the agency’s review of oncology drug applications. In this article, Genentech shares its experience with the AAid to date and provides recommendations for preparing the AAid and improving the process to fully realize its benefits. Keywords – assessment aid, FDA OCE pilots, oncology dr...
  • Regulatory NewsRegulatory News

    Pharma groups: FDA is exceeding its authority in risk management plan guidance

    The US Food and Drug Administration’s (FDA) draft guidance on risk management plans (RMPs) has overstepped the agency’s statutory bounds in requiring manufacturers of active pharmaceutical ingredients (APIs) as well as prescription drug manufacturers to submit risk management plans (RMPs) to avert drug shortages.   This requirement could impose the very drug shortages it is designed to prevent, instead of just targeting those products at risk of drug shortage, pharmace...
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    The impact of Brexit on food supplements and specialized food products

    This article examines the impact of diverging regulations and practices for food supplements and specialized food products since the UK left the EU market in 2020.   Keywords – Brexit, divergence, food supplements, UK, Northern Ireland   Background and introduction On 23 June 2016, the UK, comprising England, Northern Ireland, Scotland, and Wales, held a referendum on whether the UK should remain in the EU or leave. Based on an overall majority of 51.9% on ...
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    June’s Regulatory Focus: Nutrition in health and disease management

    Feature articles in June examined food safety in China, US Food and Drug Administration (FDA) guidance on supply chain disruptions, possible updates to the US Dietary Supplement Health and Education Act (DSHEA), and FDA and Federal Trade Commission (FTC) regulation of dietary supplements intended for treating or preventing certain mental health disorders.   Safety, disruptions, and responsive policy  China has improved its overall food safety situation significant...
  • Feature ArticlesFeature Articles

    An update of China’s food safety regulatory framework

    This article reviews the changes in China's national food safety control system and update on national food safety standard system and describes the country's unique regulations and requirements for the regulatory control of infant formula, health foods (functional foods), and food for special medical purposes (FSMP). Keywords – infant formula; food for special medical purposes; food regulatory control; food safety; food standards   Introduction Since the m...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on food effect studies, issues draft on contamination prevention for non-penicillin beta-lactam drugs

    The US Food and Drug Administration (FDA) recently issued two guidances for industry: a final guidance on how to conduct food effect studies for oral drugs being considered for investigational new drug (IND) and new drug applications (NDAs), and a draft guidance outlining a current good manufacturing practice (CGMP) framework for preventing penicillin from cross contaminating non-penicillin beta-lactam drugs and compounds. Food effect studies   The final guidance on...
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    FDA prevented record number of drug shortages in 2021

    The US Food and Drug Administration (FDA) prevented 317 drug shortages in 2021, the highest number since the agency began tracking drug shortages in 2012, according to a recent report released by the agency.   The agency’s Center for Drug Evaluation and Research (CDER) has been tracking drug shortages since the Food and Drug Administration Safety and Innovation Act (FDASIA) was passed in 2012, which requires FDA to release an annual report to Congress; FDA’s Center f...
  • RoundupsRoundups

    FDA Approvals Roundup: Evrysdi, Kymriah, Tibsovo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Evrysdi gets label extension for use in babies with spinal muscular atrophy Genentech’s Evrysdi ( risdiplam; powder for oral solution ) has been granted a new indication to include babies younger than 2 months with spinal muscular atrophy (SMA).   The approval is based on interim findings from the RAINBOWFISH study in newborns demonstrat...