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  • Regulatory NewsRegulatory News

    CDC advisory committee ponders COVID vaccine priorities

    Health care workers would be among the first to receive vaccines against COVID-19 in a timeline presented to the Centers for Disease Control and Prevention’s (CDC’s) vaccines advisory committee. The proposed scheme would have essential workers next in line for vaccination, ahead of those with serious medical comorbidities and most of the elderly. In a 23 November meeting, CDC’s Advisory Committee on Immunization Practices (ACIP) heard presentations and advice from a work...
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    Updated: Pfizer files EUA for COVID vaccine; FDA sets adcomm for 10 December

    With favorable results from a completed Phase 3 clinical trial of their jointly developed vaccine against COVID-19, Pfizer and BioNTech have submitted an emergency use authorization (EUA) application to the US Food and Drug Administration (FDA) according to Pfizer CEO Albert Bourla. The agency has set a 10 December date for the Vaccines and Related Biological Products Advisory Committee to review the EUA request. The meeting will be broadcast live on Facebook, Twitter, ...
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    Draft FDA guidance addresses oncology drug cross labeling

    In response to increasing requests from sponsors applying for oncology drugs intended to be used in combination regimens, the US Food and Drug Administration has released draft guidance for how oncology drugs used in combination regimens can be referenced by means of cross-labeling.   "Oncology drug applications to the FDA often add investigational drugs to current regimens to create new combination regimens with greater efficacy or safety,” said Richard Pazdur, MD, di...
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    WHO backs off on remdesivir as FDA issues another EUA

    The World Health Organization is recommending against the use of the antiviral remdesivir (Veklury, Gilead) for the treatment of COVID-19.   “The antiviral drug remdesivir is not suggested for patients admitted to hospital with COVID-19, regardless of how severely ill they are, because there is currently no evidence that it improves survival or the need for ventilation,” according to the World Health Organization’s (WHO’s) Guideline Development Group, in a statement re...
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    EMA sets 50% efficacy goal – with flexibility – for COVID vaccines

    The European Medicines Agency (EMA) has released its planned framework for issuing marketing authorizations for vaccines against COVID-19, as the agency continues its rolling reviews of candidate vaccines. Rather than setting hard-and-fast efficacy standards, the guidance lays out EMA’s expectations, while allowing room for a balanced evaluation for conditional marketing authorization of a vaccine during the pandemic.   In terms of efficacy, EMA is expecting to see at ...
  • ReconRecon

    Recon: Pharma supply chain vulnerable during COVID; OIG takes aim at pharma speaker program

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer, Moderna Discussing When To Drop Controls In COVID Vaccine Trials With US Government ( Pink Sheet ) When will COVID-19 vaccines be widely available? Feds lay out an ambitious timeline ( Fierce Pharma ) FDA and FTC issue more warning letters citing products and services making illegal COVID claims ( Science-Based Medicine ) House OKs Bill To Join Global ...
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    COVID rapid diagnostic options expand with at-home LAMP test

    US Food and Drug Administration (FDA) has granted emergency use authorization (EUA) to the first COVID-19 diagnostic test that can be used to provide rapid results at-home.     The newly authorized Lucira COVID-19 All-in-One test kit is a molecular test that uses real-time loop-mediated amplification (LAMP) technology to detect the presence of SARS-CoV-2, the virus that causes COVID-19. The test enters the market as the pandemic surges worldwide and governments are re-...
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    Statutory deadline for OTC hearing aid rule missed by FDA

    Despite ongoing assurances that it will address the matter of over-the-counter hearing aids, the US Food and Drug Administration (FDA) has missed another deadline to issue a proposed rule on the devices.   According to correspondence sent by two US senators to FDA Commissioner Stephen Hahn, MD on 13 October, FDA has missed its statutory deadline of 18 August 2020 to issue proposed guardrails for the marketing of over-the-counter (OTC) hearing aids, as required in the 2...
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    FDA commits to data transparency in COVID EUAs

    As the time draws near for the leaders in the global race for a vaccine against COVID-19 to submit emergency use authorization (EUA) authorizations to the US Food and Drug Administration (FDA), the agency has proclaimed a new commitment to transparency.   With a stated goal of disclosing information from COVID-19-related EUA review documents “as appropriate and consistent with our longstanding practice of posting scientific reviews after new drug and biological product...
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    NIH director: Efficacy for co-developed Moderna vaccine nears 95%

    The director of the National Institutes of Health (NIH) reported favorable efficacy results after an interim analysis of data from the COVE Phase 3 efficacy trial of mRNA-1273, the messenger RNA vaccine candidate the agency co-developed with the biotechnology company Moderna.   In a NIH Director’s Blog post released on the same day Moderna issued a press release announcing interim efficacy figures topping 94% for its vaccine candidate, Francis Collins, MD, shared fav...
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    Device sponsors get detailed electromagnetic compatibility guidance from FDA

    Medical device manufacturers have new draft guidance on electromagnetic compabitility from the US Food and Drug Administration (FDA). The new 20-page guidance delves into much more detail than the six pages of the 2016 final guidance it is destined to replace.   Electromagnetic compatibility (EMC) – the ability of a device to function safely and effectively in the electromagnetic environment in which it is intended to be used – includes both immunity to EM interferen...
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    EMA's CHMP gives Gamifant a second thumbs down; approves five new medicines

    In its November meeting, a committee of the European Medicines Agency gave its second thumbs down to the monoclonal antibody Gamifant (emapalumab), confirming a July 2020 negative opinion on the Novimmune SA drug.   The US FDA approved Gamifant for pediatric use in primary hemophagocytic lymphohistiocytosis in November 2018; this was the same indication for which EMA has twice declined authorization.   EMA’s human medicines committee (CHMP) had positive recommendat...