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  • Regulatory NewsRegulatory News

    FDA: Include premenopausal women in breast cancer trials

    Premenopausal women should be considered for inclusion in breast cancer clinical trials, according to new draft guidance from the US Food and Drug Administration (FDA). “Menopausal status should not be the basis of exclusion from any breast cancer clinical trial,” says the draft guidance, which was made available for a 60-day consultation period on 7 October.   The draft guidance puts forward recommendations to help move clinical breast cancer research away from the hi...
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    FDA issues COVID-19 vaccine EUA guidance after clash with White House

    Amid reports that the White House had blocked stricter guidance from the US Food and Drug Administration (FDA) on emergency use authorizations (EUAs) for COVID-19 vaccines, the agency on Tuesday issued guidance hours after disclosing some of its advice to vaccine makers in briefing documents for an upcoming advisory committee meeting.   Last month, agency officials, including FDA Commissioner Stephen Hahn and Center for Biologics Evaluation and Research (CBER) Director...
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    CDER’s NextGen Portal now accepts manufacturing capacity submissions

    The US Food and Drug Administration (FDA) announced the availability of an online option for sponsors of investigational new drugs to submit manufacturing capacity data.   By registering and going through the Center for Drug Evaluation and Research (CDER)’s NextGen Portal, sponsors can provide the agency with information about the specific investigational new drug (IND) application and the manufacturer, along with details about rates of production, treatment courses, c...
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    FDA seeks withdrawal of Makena, generics from market

    The US Food and Drug Administration (FDA) on Monday proposed to withdraw Amag Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate injection) and its generics from the market after a postmarket study failed to confirm clinical benefit.   The request comes nearly a year after FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee recommended that the agency withdraw its approval for the drug and more than nine years after it received accelera...
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    FDA announces all-time low rates for FY2021 PRVs

    The US Food and Drug Administration (FDA) has announced historic low rates for the fiscal year 2021 fees to use its three priority review voucher programs.   For the upcoming fiscal year, the rate to use a material threat medical countermeasure (MCM) priority review voucher (PRV) is an all-time low $1,360,879. The PRV rate is the same for the rare pediatric disease and rare tropical disease voucher programs, according to Federal Register announcements.   This figur...
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    Misleading ads for asthma, weight loss meds garner warning letters

    Emails from an executive and sales staff falsely touted an inhaled steroid preparation as a treatment for COVID-19, prompting a warning from the branch of the US Food and Drug Administration (FDA) that oversees drug promotion. This communication, together with one directed to the application holder of a weight loss medication, made the third and fourth warning letters of the year issued by FDA's Office of Prescription Drug Promotion (OPDP).    In a 24 September let...
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    Report: FDA REMS program ineffective at curbing opioid misuse

    The US Food and Drug Administration (FDA) has been using the Risk Evaluation and Mitigation Strategies (REMS) program as a way to mitigate adverse events stemming from opioid misuse and abuse, but that program is a poor tool for fighting the opioid epidemic, the Health and Human Services Office of the Inspector General concluded in a new report .   The REMS program is a long-standing drug safety program that has allowed the FDA to require manufacturers to implement ...
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    Consider a variety of endpoints for OUD treatments: FDA guidance

    Consider a variety of endpoints for OUD treatments: FDA guidance   A new final guidance document from the US Food and Drug Administration (FDA) gives drugmakers considerations for choosing endpoints for new medications to treat opioid use disorder (OUD).   “We recognize that there’s great interest in developing new treatment options that result in meaningful outcomes, said FDA Commissioner Stephen Hahn, MD, in announcing the final guidance, which has only minor c...
  • ReconRecon

    Recon: Breakthrough status for Farxiga; 'Transformative' Zolgensma data

        Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US President Trump Tests Positive for Coronavirus ( WSJ ) ( NYT ) ( Washington Post ) ( CNBC ) ( Politico ) ( BBC ) ( Reuters ) First doses of US vaccine must be strictly rationed, says report ( Financial Times ) Dr. Scott Gottlieb sees antiviral remdesivir as best coronavirus treatment should Trump need one ( CNBC ) Where was Trump — and who was he with ...
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    FDA gives draft adjuvant trial guidance for RCC, bladder cancer

    Two new draft guidances from the US Food and Drug Administration give investigators a roadmap for clinical trials of adjuvant drug or biologic therapy for two common cancers. The first of the guidances released on 1 October addresses adjuvant treatment for bladder cancer, and the other addresses adjuvant treatment of renal cell carcinoma (RCC).   “Currently, there is significant variability in the design, conduct, and analysis of clinical trials” that examine adjuvant ...
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    EMA kicks off rolling review of AstraZeneca COVID vaccine candidate

    The European Medicines Agency (EMA) has begun a rolling review of the COVID-19 vaccine being developed by AstraZeneca and the University of Oxford. This is the agency’s first review of a vaccine against SARS-CoV-2, the virus that causes COVID-19.   EMA’s human medicines committee (CHMP) has begun with an evaluation of non-clinical data, announced EMA on 1 October. The rolling review is meant to hasten the time to a decision on the safety and effectiveness of a therap...
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    FDA releases draft guidance for physiologically based PK analyses

    The US Food and Drug Administration (FDA) has issued draft guidance for industry on the use of physiologically based pharmacokinetic (PBPK) analyses for biopharmaceutics applications. A PBPK analysis uses models and simulations combining physiology, population, and drug substance and product characteristics to mechanistically describe the pharmacokinetic or pharmacodynamic behaviors of a particular drug product, according to the FDA. The idea behind using this techni...