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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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    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...
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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 clarifies reporting post-approval changes for disposable manufacturing materials

    The US Food and Drug Administration (FDA) on Friday issued a question-and-answer guidance  to provide clarity to manufacturers on reporting post-approval changes to disposable manufacturing material.   The guidance covers changes made to new drug applications (NDAs), biologics license applications (BLAs) or abbreviated new drug applications (ANDAs) and applies to all manufacturing establishments, including those that perform functions under contract.   During the...
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    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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    FDA approval lowers, but doesn’t eliminate disparities in immunotherapy use

    Racial, ethnic and sociodemographic disparities that are present in clinical trials and compassionate use agreements for cancer immunotherapy during the pre-approval period are reduced, but not eliminated after the US Food and Drug Administration (FDA) approves these cancer treatments, according to recent research published in JAMA Network Open .   “The time frame leading up to FDA approval is an important period in which to observe disparities,” Theresa Ermer, MD, of...
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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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    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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    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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    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...