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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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    Accelerating drug development and approvals in India

    India’s Central Drugs Standard Control Organization (CDSCO) implemented the New Drugs and Clinical Trials Rules in 2019 to expedite the drug development and approval processes. This article provides an overview of those processes; explains the rule-specific terminology, such as the definitions of “drug” and “new drug” under Indian law; and outlines strategies for speeding up the approval processes and optimizing registration of prescription medicines in India.   Keywo...
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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

    Health policy experts call for stronger accelerated approval reforms

    The US Congress should take concerns raised by the Food and Drug Administration (FDA) seriously and give the agency more authority around accelerated approvals, including the power to expedite the withdrawal of drugs from the market, according to a perspective article from three experts on drug regulation and health policy.   The perspective, written by Rachel E. Sachs, JD, MPH, of Washington University in St. Louis, Julie M. Donohue, PhD, of the University of Pittsbur...
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    Former FDA officials call for more transparency for drug approvals

    The US Food and Drug Administration (FDA) needs to take a more proactive approach in combatting misinformation and communicating decisions to the public when approving drugs, especially when the decision goes against the recommendations of its advisory committees. Not doing so will continue to undermine the public’s trust in the agency, said a panel of former FDA commissioners and others at the Food and Drug Law Institute (FDLI) annual conference on Tuesday.   Califf ad...
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    MDCG urges manufacturers to use MDR transition period wisely

    The European Commission’s Medical Device Coordination Group (MDCG) on Monday said that manufacturers should start preparing now to ensure “timely compliance” with the Medical Device Regulations (MDR) by the time the regulation is fully applicable on 27 May 2024. Devices not certified by this date will no longer have access to the EU market, except in rare circumstances discussed in the notice.   MDCG reiterated that “to ensure that devices can continue to be placed o...
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    Expedited regulatory pathway options and utility: Pandemic to endemic

    Expedited regulatory programs recognize the need for products targeting serious illnesses with unmet clinical need to proceed to market as soon as possible, without necessarily providing the amount of evidence required for regular market authorization. During the COVID-19 pandemic, there has been a race to develop treatments and vaccines, and the length of time required for regulatory considerations has been widely discussed. We seek to determine whether emerging regulator...
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    FDA officials aim to stop misuse of the term ‘digital biomarker’

    While a lot of researchers claim they are capturing digital biomarker data, they may in fact be collecting clinical outcomes assessment (COA) data according to some US regulators. To clarify the differences, top US Food and Drug Administration (FDA) officials have defined digital biomarkers versus other kinds of data in a new article.   According to FDA officials in an article published on 25 March in npj Digital Medicine , a digital biomarker is “a characteristic o...
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    January’s Regulatory Focus: Leadership in RA, expanding diversity, and more

    Feature articles during January focused on regulatory leadership, a novel approach to hiring regulatory professionals, expedited programs for reducing time to approval for certain drugs, and the Cuban biotechnology industry and its response to COVID-19. Keywords – assessment aid, breakthrough therapy, Cuba, diversity, ILAP, leadership, PRIME   Leadership, hiring, and expanding diversity Effective leadership in regulatory affairs is rooted in an understanding a...
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    Califf, experts eye legislative fix for accelerated approval program

    Regulatory and industry experts agree that completing confirmatory studies quickly is essential to the success of the US Food and Drug Administration’s (FDA) accelerated approval program, with some suggesting that new legislation might be necessary to reliably get results from these trials in a timelier manner.   Robert Califf, head of clinical policy and strategy for Verily and Google Health and the Biden Administration’s nominee to be FDA commissioner, said a legisla...
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    FDA approved more first-in-class drugs, gave more accelerated approvals in 2021

    The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure is a slight decrease from 2020 , more drugs were designated as first-in-class and used the accelerated approval pathway than in previous years.   The approvals reported by CDER do not include biologics license applications (BLAs) approved by FDA’s Center for Biologics Evaluation and Research (CBER). In 2021, CBER approved...
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    Exclusive accelerated approval drugs comprise ‘relatively small share’ of Medicare spending

    Policymakers looking to rein in Medicare spending should look beyond the lens of the accelerated approval pathway, as drugs that exclusively fall under this indication make up a small percentage of overall Medicare spending, according to a recent research letter written by Benjamin N. Rome, of the Program on Regulation, Therapeutics, And Law (PORTAL) research group at Harvard Medical School and Brigham & Women’s Hospital, and colleagues.   “Medicare is spending more an...