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    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...
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    Regulatory ad promo in a co-promotion setting

    Co-promotion agreements between two pharmaceutical companies amplify marketing efforts for a product and boost market penetration. It entails collaboration between the companies during the review and approval of the promotional and nonpromotional product information materials. This article will focus on co-promotion in the regulatory advertising and promotion (ad promo) setting. It includes basic principles and best practices in implementing the promotional review process ...
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    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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    Starting out as an ad promo reviewer

    This article provides a brief overview of what to expect when starting out as a regulatory advertising and promotion (ad promo) reviewer and includes recommendations for some basic introductory resources.   Keywords – advertising and promotion, regulations, reviewing, starting out   Introduction Regulatory ad promo review is more an art than a science, and learning how to apply the specific laws, regulations, and guidances is an ongoing process. There is a lot...
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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 ...
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    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...
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    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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    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...
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    Quality metrics: FDA wants feedback on pared-down program

    The US Food and Drug Administration (FDA) on Wednesday outlined a pared-down plan to collect quality metrics data from drugmakers in an attempt to renew its earlier stalled effort to obtain manufacturing quality data as a means of mitigating potential drug shortages and promoting enhanced quality management in the pharmaceutical industry.   The agency stressed in an announcement that this program would be different from the original quality metrics draft guidance unv...
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    NASEM report: FDA should disclose drug and device manufacturing information

    To ensure resiliency in the medical supply chain, the US Food and Drug Administration (FDA) should publicly disclose the location of all manufacturing facilities that supply ingredients and parts for pharmaceuticals and medical devices approved in the US, according to a consensus study report from the National Academies of Science, Engineering and Medicine (NASEM).   This is one of seven recommendations in a 365-page report on building supply chain resiliency. The re...
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    Orphan drug experts discuss new book on developing rare disease treatments

    Developing therapies for rare diseases involves complex incentives, unique requirements, and often extensive patient engagement. The authors of RAPS’ Orphan Drug Development for Rare Diseases , Sundar Ramanan, PhD, MBA, and Sunny Kamlesh Dave, MPharm, recently took time to discuss with RAPS Senior Editor Gloria Hall the importance of orphan drugs, the peculiarities and challenges of obtaining an orphan drug designation (ODD), and what is covered in the book. During a “m...