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  • Regulatory NewsRegulatory News

    Generic drugmakers get cannabidiol bioequivalence guidance from FDA

    Manufacturers who seek to produce generic versions of cannabidiol oral solution received guidance from the US Food and Drug Administration (FDA) on establishing bioequivalence with the reference listed drug.   The guidance follows the June 2018 approval of Epidiolex (cannabidiol) oral solution to treat seizures associated with two rare and serious types of childhood epilepsy. Epidiolex was also approved to treat a third seizure condition, tuberous sclerosis complex, in...
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    RAPS welcomes new Ontario Chapter

    RAPS has announced the official launch of the RAPS Ontario Chapter , which first began as a RAPS-affiliated local networking group. Ontario joins Vancouver as the second RAPS chapter in Canada and expands RAPS’ global network to now include 20 chapters and eight local networking groups. “We are very excited about the formal launch of our chapter in the RAPS regulatory community,” said founding member and Ontario chapter chair, Ntsakisi Onibayo, RAC, regulatory complian...
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    COVID-19 vaccine: Experts warn of waning public confidence

    Conflicting messages and priorities between vaccine makers and federal leaders serve only to exacerbate public mistrust of potential COVID-19 vaccines, according to a perspective piece from Harvard professors published in the New England Journal of Medicine .   Jerry Avorn, MD, and Aaron Kesselheim, MD, both from the division of pharmacoepidemiology and pharmacoeconomics at Harvard Medical School, took to the august publication to share their thoughts on the juxtaposi...
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    Adverse event reporting clarified in FDA’s COVID-19 clinical trial guidance

    Investigators of new drugs must continue to send safety reports of serious and unexpected adverse events to their institutional review boards during the public health emergency of the novel coronavirus pandemic, according to an updated guidance from the US Food and Drug Administration (FDA).    The updated information came on 21 September 2020 in the form of a new addition to the questions and answers in the FDA's guidance on conduct of clinical trials of medical pro...
  • RoundupsRoundups

    Asia-Pacific Roundup: COVID-19 vaccine guidelines in India

    India’s Central Drugs Standard Control Organization (CDSCO) has published draft guidelines about the development of COVID-19 vaccines, falling in line other regulatory agencies by setting the bar for vaccine efficacy at a 50% reduction in infections, for example.   Several COVID-19 vaccines are in clinical development in India, including candidates from AstraZeneca, Bharat Biotech and Zydus Cadila (RELATED: COVID-19 vaccine tracker , Regulatory Focus 17 Sept. 2020)....
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    FDA releases guidance on inclusion of geriatric information in drug labeling

    The US Food and Drug Administration (FDA) has issued draft guidance on the content and placement of information specific to geriatric patients in drug and biologic labeling.   The guidance document, issued in September 2020, replaces a previously withdrawn guidance document – “Content and Format for Geriatric Labeling” – initially released in October 2001.   The new draft guidance provides examples of specific geriatric use statements and examples of when the FDA...
  • ReconRecon

    Recon: COVID vaccine makers see EU liability shield; BMS lands FDA priority review for ide-cel CAR-T therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Decision Time Looms for Biotech’s Riskiest Bet ( WSJ ) After bruising rejection, bluebird and Bristol Myers Squibb land ide-cel priority review. But will it matter for the CVR? ( Endpoints ) ( Press ) Medicare Wouldn’t Cover Costs of Administering Coronavirus Vaccine Approved Under Emergency-Use Authorization ( WSJ ) CDC Advisory Panel to Delay Vote on Initial...
  • Feature ArticlesFeature Articles

    Regulatory tools for generic drug companies: Formal FDA meetings and controlled correspondence

    This article discusses formal meetings and controlled correspondence for the generic drug industry and the use of these regulatory tools in the abbreviated new drug application (ANDA) process. The author notes that these tools are useful in understanding the current thinking of the US Food and Drug Administration (FDA) to avoid unexpected delays for product approval as well as expedite faster generic drug approvals.   Introduction Generic drugs are copies of innovato...
  • WHO: Two-thirds of global population now participating in COVAX initiative

    Countries representing nearly two thirds of the world’s population have now signed on to The World Health Organization’s COVID-19 vaccine development and manufacturing accelerator. In all, 64 higher income countries have joined the COVAX facility, with an additional 38 expected to join soon. The United States, Russia and China are not among the countries joining the multinational effort.   World Health Organization (WHO) director-general Tedros Ghebreyesus led a 21 Sep...
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    EMA backs dexamethasone for COVID-19, seven new medicines and consults on ICH Q3D guideline

    The European Medicines Agency’s (EMA) on Friday recommended seven medicines for marketing authorization and began a public consultation on the International Council for Harmonisation’s (ICH) Q3D(R2) guideline on elemental impurities.   EMA also endorsed the use of dexamethasone to treat coronavirus disease (COVID-19) patients who are on oxygen or mechanical ventilation based on results from the RECOVERY trial.   “Published data from the RECOVERY study show that, in...
  • Feature ArticlesFeature Articles

    Manufacturer obligations applying to importers, distributors, or others under MDR and IVDR

    This article discusses issues and requirements spelled out in MDR and IVDR Chapter 2 and that chapter’s Article 16, which applies to manufacturer’s obligations and responsibilities. The author addresses new quality management system (QMS) requirements for repacking and translation of labeling, and the QMS certification obligations. Also covered are cases in which manufacturer obligations apply to importers, distributors, or other persons; changing a device’s intended purpo...
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    First virtual RAPS Convergence draws nearly 1,500 participants, earns praise

    RAPS last week wrapped up its first RAPS Convergence conference to be held completely online. RAPS Convergence is the largest annual gathering of the global healthcare regulatory community and the only US event exclusively dedicated to the regulatory profession. RAPS completely redesigned this year’s conference, transforming what has traditionally been a face-to-face event in a different host city each year, into a live, virtual, interactive experience for the nearly ...