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    FDA Issues Guidance on Maximal Usage Trials for OTC Drugs

    The US Food and Drug Administration (FDA) on Tuesday issued draft guidance for drugmakers on the design and conduct of maximal usage trials for the purpose of adding a topical active ingredient to an over-the-counter (OTC) drug monograph.   Maximal usage trials are conducted to determine the in vivo bioavailability of topical drugs and can help the agency understand the potential for systemic exposure to a topically applied active ingredient.   “Such information ...
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    FDA Finalizes Guidance on Developing Anthrax Treatments

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance on developing drugs to protect against inhalation anthrax.   The guidance finalizes a draft released in 2016 and has been updated to revise the indication of prophylaxis of inhalation anthrax to cover both the pre- and post-exposure settings.   The indication now reads "to reduce the risk of disease in persons who have inhaled, or are likely to imminently inhale, aerosolized B. anthracis sp...
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    EMA Report Makes Recommendations for CAR-T Patient Registries

    A new report from the European Medicines Agency (EMA) lays out recommendations for improving the use of patient registries to support the benefit-risk evaluation of chimeric antigen receptor (CAR) T-cell therapies.   The report comes as EMA considers whether to approve the first batch of CAR T-cell products submitted to it for marketing authorisation, including applications for Kite’s Yescarta (axicabtagene ciloleucel) and Novartis’ Kymriah (tisagenlecleucel) , both...
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    Singapore Eases Registration Requirements for Some Devices

    Singapore's Health Sciences Authority (HSA) on Tuesday announced changes to its regulations that it says will facilitate faster access to certain medical devices and mobile applications and provide more clarity to device makers. Specifically, the agency says it plans to exempt some devices from registration requirements based on risks and other factors, such as whether the device is approved by other international regulators and how long it has been on the market. "HSA ...
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    FDA Seeks Input on pH-Dependent Drug-Drug Interactions

    Following the release of two draft guidances on enzyme- and transporter-based drug-drug interactions (DDIs) last year, the US Food and Drug Administration (FDA) is asking for input on developing new guidance on assessing pH-dependent DDIs. Those guidances, Clinical Drug Interaction Studies – Study Design, Data Analysis, and Clinical Implications and In Vitro Metabolism- and Transporter-Mediated Drug-Drug Interaction Studies were developed to aid drugmakers when ev...
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    FDA Issues Two Final and One Draft Drug Development Guidances

    The US Food and Drug Administration (FDA) issued two final guidances meant to assist sponsors looking to develop products to treat or prevent acne vulgaris and hypogonadotropic hypogonadism, as well as a draft guidance on developing drugs to treat or prevent cytomegalovirus in transplant patients.   Specifically, these guidances discuss drug development considerations for the particular diseases, including preclinical factors, clinical trial enrollment criteria, study ...
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    FDA, EMA Recommend Safety Precautions for ViiV HIV Drug

    The US Food and Drug Administration (FDA) and the European Medicines Agency's (EMA) are recommending new safety precautions for ViiV Healthcare's HIV drug dolutegravir.   Dolutegravir is the active ingredient in three of ViiV's products, Tivicay (dolutegravir) and two fixed-dose combination drugs, Juluca (dolutegravir/rilpivirine) and Triumeq (abacavir/dolutegravir/lamivudine).    The recommendations are based on the preliminary findings of a large observational study...
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    Guidance on IRB Written Procedures Finalized

    The US Food and Drug Administration (FDA) and Department of Health and Human Services’ (HHS) Office for Human Research Protections on Thursday finalized guidance on the written procedures institutional review boards (IRBs) are expected to maintain and follow.    IRBs are bodies established to approve and oversee studies involving human research subjects in order to ensure that participants are adequately protected.    The guidance finalizes a  draft version  from in 2...
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    FDA Begins Naming Firms Accused of Stalling Generic Competitors

    Months after Food and Drug Administration (FDA) Commissioner Scott Gottlieb called on drugmakers to “ end the shenanigans ” that delay generic competition, the agency has published a list of companies that may be restricting access to samples of their products to generic firms.   “Today we’re making public a list of companies that have potentially been blocking access to the samples of their branded products. We hope that this increased transparency will help reduce un...
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    FDA Faster Than Global Peers at Approving New Drugs

    A report from the Centre for Innovation in Regulatory Science (CIRS) released this month finds that the US Food and Drug Administration (FDA) has reclaimed its position as the fastest major regulator for approving new drugs and biologics.   According to the report, FDA spent a median 243 days to approve products with a new active substance (NAS) in 2017, 90 days faster than its closest peer, Japan's Pharmaceuticals and Medical Devices Agency (PMDA), which took a median...
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    EMA Adopts ICH Q&A on Nonclinical Evaluation for Cancer Drugs

    The European Medicines Agency (EMA) on Wednesday adopted the International Conference on Harmonisation's (ICH) questions and answers guideline on the nonclinical evaluation of anticancer drugs.   The 17-page document includes 41 questions and answers offering additional clarity on ICH S9 , including information on studies to support nonclinical evaluations such as toxicology studies and nonclinical data to support trial design and marketing.   The agency's Committ...
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    Pfizer’s Epoetin Alfa Biosimilar Approved by FDA

    The US Food and Drug Administration (FDA) on Tuesday approved the first biosimilar to Amgen’s blockbuster Epogen/Procrit (epoetin alfa), bringing the total number of biosimilars approved by the agency to 10. The biosimilar, called Retacrit (epoetin alfa-epbx), will be marketed by Pfizer’s Hospira unit and is approved for the same indications as Epogen/Procrit, including treatment of anemia caused by chronic kidney disease, chemotherapy or use of zidovudine in patients w...