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  • ReconRecon

    Recon: FDA approves first Ebola therapy; Advocacy groups push WTO on COVID IP rights

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA Chief Defends Vaccine-Trial Halts as Vital to Safety System ( Bloomberg ) Examination shows how widely pharma showers campaign cash at the state level ( STAT ) Vertex, Amgen could be seeking new deals to fuel growth following pipeline stumbles ( STAT ) Vertex shelves experimental rare lung disease drug that once seemed promising ( STAT ) First Ebola thera...
  • RoundupsRoundups

    Euro Roundup: MHRA to join consortium post-Brexit

    The United Kingdom is set to join Australia, Canada, Singapore and Switzerland in a regulatory consortium when it splits from the European Union at the start of next year, enabling companies to access all five markets using a single application.   Since before the 2016 Brexit vote, drug developers have warned that leaving the EU could delay access to new medicine for UK patients. The Medicines and Healthcare products Regulatory Agency (MHRA) has responded to the concer...
  • Regulatory NewsRegulatory News

    During pandemic, FDA permits some respiratory swab, media swaps

    Amid the coronavirus pandemic, the US Food and Drug Administration (FDA) has made new guidance immediately effective that addresses its enforcement policy for modifications to previously cleared molecular tests for other common respiratory pathogens.   During the public health emergency of the COVID-19 pandemic, FDA does not intend to enforce the requirement for obtaining 510(k) clearance for certain modifications of molecular respiratory pathogen tests, including use ...
  • RoundupsRoundups

    FDA Approvals Roundup: New formulation for Ultomiris

    New formulation Ultomiris gets new formulation for blood-related disorders  Alexion’s Ultomiris (ravulizumab-cwvz injection) has been  approved  as a 100 mg/mL formulation for treating adults with paroxysmal nocturnal hemoglobinuria (PNH) and for atypical hemolytic uremic syndrome (aHUS) for adults and children aged one month or older.  The  new  formulation of the complement inhibitor will cut annual infusion time by about 60%, or six hours, compared with the 10 m...
  • Regulatory NewsRegulatory News

    Testing requirements are likely slowing biosimilar entries in the US

    Biosimilars have been slow to enter the US market for complex reasons ranging from the manipulation of patent protections to brand-name drug rebates. Now a new analysis, published in the Mayo Clinic Proceedings , suggests that a “high testing bar” for biosimilars to gain regulatory approval is another contributing factor. The analysis found that the median time from the start of a Phase I study to approval by the US Food and Drug Administration (FDA) was more than 5 ye...
  • Regulatory NewsRegulatory News

    TGA gives Pfizer COVID vaccine provisional determination

    Another vaccine against SARS-CoV-2, the virus that causes the novel coronavirus, has received provisional determination from Australia’s Therapeutic Goods Administration (TGA). Pfizer, doing business in Australia as Pfizer Australia Pty Ltd, received the determination on 14 October for its messenger ribonucleic acid (mRNA) COVID-19 vaccine candidate, BNT162b2.   The decision comes after a 9 October decision by TGA to grant provisional determination to AstraZeneca’s rec...
  • ReconRecon

    Recon: Eli Lilly COVID antibody trial paused; Health Canada to review Moderna COVID vaccine in real time

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA faults quality control at Lilly plant making Trump-touted COVID drug ( Reuters ) Eli Lilly’s Antibody Trial Is Paused Over Potential Safety Concern ( NYTimes ) Lilly says other COVID-19 antibody drug trials ongoing after study halted for safety concern ( Reuters ) FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’ ( Politi...
  • Feature ArticlesFeature Articles

    Starting out: A beginner’s toolkit of US regulatory resources

    This article offers a selection of 28 publicly available resources for newcomers to the regulatory profession. The author recommends many US Food and Drug Administration (FDA) websites, including information and guideline resources from a number of the agency’s centers and their respective websites and searchable databases.   Introduction The FDA website is the go-to platform for US-related regulatory information ( Table 1 [1]). This multipurpose learning and resea...
  • Regulatory NewsRegulatory News

    Generic drugmakers get revised MAPP for suitability petitions

    A newly revised policy and procedure manual is available to generic drugmakers who wish to submit an abbreviated new drug application (ANDA) to the US Food and Drug Administration (FDA) for a formulation that differs in certain ways from the reference listed drug.   The Manual of Policies and Procedures (MAPP) published by FDA’s Office of Generic Drugs lays out how applicants can petition FDA  to submit an ANDA when the generic drug differs from the reference listed dr...
  • RoundupsRoundups

    Asia-Pacific Roundup: Japan’s PMDA shares principles for evaluation of COVID-19 vaccines

    Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published principles for evaluating COVID-19 vaccines. The principles echo guidelines published in other parts of the world, for example by recommending that studies are designed to show vaccines prevent COVID-19.   PMDA, like its peers, is against the use of surrogate measures given the lack of evidence linking them to the key endpoint of COVID-19 prevention. Clinical trials to assess the preventive effect ...
  • Regulatory NewsRegulatory News

    TGA explains how it will handle lapsed conformity assessments due to MDR delays, COVID

    Australia’s Therapeutic Goods Administration (TGA) on Tuesday released guidance explaining its approach to medical device conformity assessment recertification in light of delays in the implementation of the EU Medical Devices Regulation (MDR) and disruptions caused by the COVID-19 pandemic.   “[TGA] is issuing this guidance to inform sponsors … about the general approach the TGA will take to the lapsing of conformity assessment documents due to delays in audits due ...
  • RAPS AnnouncementsRAPS Announcements
    RAPS' LatestRAPS' Latest

    Regulatory professionals’ average compensation continues to increase, according to RAPS’ 2020 compensation survey

    RAPS today released the results of its biennial global survey of regulatory professionals working in the healthcare products sector. RAPS’ 2020 Global Compensation & Scope of Practice Report for the Regulatory Profession provides a detailed look at how much regulatory professionals earn, who they are, and what their work entails. The comprehensive survey collected salary and demographic data for nearly 2,000 respondents from around the world. The average total compens...