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  • Regulatory NewsRegulatory News

    MHRA posts suite of post-transition guidances

    The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) on Tuesday released more than two dozen guidance documents explaining how drugs, medical devices, clinical trials and more will be regulated after the Brexit transition period expires on 1 January 2021.   Clinical trials   Two guidances related to clinical trials explain requirements for the registration of clinical trials for investigational medicinal products and the submission of substantial ...
  • ReconRecon

    Recon: FDA communications shakeup continues; EU considers joining WHO vaccine purchasing scheme

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA to bring outside experts to review COVID-19 vaccines ( Reuters ) FDA shake-up continues as another comms official removed from top role ( Politico ) Convalescent plasma not recommended to treat COVID-19, government panel says ( NBC ) ( FT ) US says it won’t join WHO-linked effort to develop, distribute coronavirus vaccine ( Washington Post ) Trump says he...
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    FDA warns Mylan, Acella Pharmaceuticals over GMP violations

    The US Food and Drug Administration (FDA) last month warned Mylan Laboratories and Acella Pharmaceuticals over good manufacturing practice (GMP) violations.   Mylan Laboratories   FDA’s warning letter to Mylan comes after the agency inspected the company’s facility in the Sangareddy District of Telangana, India over the course of a week last February.   The warning letter, which cites the company for issues related to its cleaning procedures and handling of r...
  • ReconRecon

    Recon: AstraZeneca begins US Phase III COVID vaccine study; FDA approves Medtronic’s new automated insulin delivery system

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Early vaccine approval is biggest test yet for FDA chief ( FT ) As fears of a politically-motivated vaccine EUA grow, Eric Topol delivers an ultimatum to commissioner Hahn: Stand up or resign ( Endpoints ) ( Medscape ) AstraZeneca's COVID-19 vaccine candidate begins late-stage US study ( Reuters ) Congressional committee to subpoena AbbVie in drug pricing inve...
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    Combination products: FDA releases PDUFA VI program report

    A new independent report on the US Food and Drug Administration’s (FDA) review practices for combination products under the Prescription Drug User Fee Act (PDUFA VI) gives the agency generally positive marks but finds room for refinements in communication and technology to improve the pre-submission and review process.   The report , commissioned by FDA as part of its PDUFA VI commitments, was conducted by Eastern Research Group and looked at FDA staff and sponsor e...
  • ReconRecon

    Recon: FDA expands use of remdesivir for COVID-19; Nestle to buy Aimmune for $2B

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA head says he is willing to fast-track Covid-19 vaccine ( FT ) ( Reuters ) ( The Hill ) FDA expands emergency use of Gilead's remdesivir in hospitalized COVID-19 patients ( Reuters ) ( FDA ) GSK, partner Vir join race to find COVID-19 antibody treatment ( Reuters ) ( STAT ) US scraps Philips ventilator order in 2020 earnings blow ( Reuters ) US government’...
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    FDA issues 36 new and revised product-specific guidances

    The US Food and Drug Administration (FDA) on Friday released its latest batch of product-specific guidances, posting 19 new and 17 revised draft guidances, bringing the total number of product-specific guidances issued by the agency to 1,938.   The guidances , which FDA posts quarterly, are intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug...
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    ICH updates: E14 consultation, Health Canada implements M9 guideline

    The International Council for Harmonisation (ICH) on Thursday announced its E14/S7B draft questions and answers guideline on clinical and nonclinical evaluation of QT/QTc interval and proarrhythmic potential has reached Step 2b of the ICH process.   On Friday, the European Medicines Agency (EMA) opened a three-month public consultation to gather feedback on the document. ICH will also be hosting a two-day public meeting to provide a high-level overview of the docum...
  • ReconRecon

    Recon: New FDA communications chief out after plasma debacle; WHO looks to win over more wealthy countries to COVAX facility

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump pledges a Covid-19 vaccine by end of 2020 — without acknowledging the scientific uncertainty ( STAT ) ( Endpoints ) Two PR Experts at FDA Have Been Ousted After Blood Plasma Fiasco ( NYTimes ) Employers are planning how to blunt the cost of gene therapies, pricey new specialty drugs ( STAT ) Trump administration to purchase 150 million Abbott COVID-19 te...
  • ReconRecon

    Recon: EU signs deal for AZ COVID vaccine; FDA approves Cassiopea’s acne drug Winlevi

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Trump has launched an all-out attack on the FDA. Will its scientific integrity survive? ( STAT ) Novavax CEO expects filing for COVID-19 vaccine approval in December: paper ( Reuters ) Foundation Medicine wins FDA approval for liquid biopsy able to detect mutations in multiple cancers ( STAT ) Hahn spotlights Oct 22 vaccine advisory meeting as the next big fla...
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    FDA drafts recommendations for studying cancer drugs in patients with CNS metastases

    The US Food and Drug Administration (FDA) on Wednesday issued draft guidance providing recommendations to drugmakers on evaluating cancer drugs in patients with central nervous system (CNS) metastases.   FDA says the guidance is meant to inform clinical trial designs to support product labeling that describes antitumor activity of drugs or biologics in patients with CNS metastases from solid tumors originating in other parts of the body.   "There are few effectiv...
  • Regulatory NewsRegulatory News

    Updated: FDA delays collection of drug manufacturing volume data

    The US Food and Drug Administration (FDA) on Monday announced it will not begin collecting drug manufacturing volume data next month as required by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act).   Section 3112 of the CARES Act establishes new reporting requirements for drug manufacturers intended to improve the response to drug shortages, including expanding shortage reporting requirements for life-saving drugs to include drugs that are “critical...