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  • Regulatory NewsRegulatory News

    FDA Purple Book Database now includes all CBER-, CDER-licensed biological products

    The US Food and Drug Administration (FDA), in updating the Purple Book, its database of FDA-licensed biologic products, will also include exclusivity information for biological products as well as a glossary. Biosimilar and interchangeable biological products are included in the searchable online database.   The current list of products maintained by the Center for Biologics Evaluation and Research (CBER) will not be further updated by FDA.   The agency explained t...
  • Regulatory NewsRegulatory News

    MedWatch to Manufacturers program retired in favor of FAERS dashboard

    The US Food and Drug Administration (FDA) is retiring its MedWatch to Manufacturers program, saying the FDA Adverse Event Reporting System (FAERS) public dashboard has largely supplanted the functions served by the MedWatch (MMP) program.   Since 2017, said the agency, the FAERS dashboard has given sponsors the ability to search for voluntary adverse events reports and download the reports directly. “The dashboard allows applicants to obtain the information on voluntar...
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    FDA authorizes first two semi-quantitative COVID-19 serology tests

    The US Food and Drug Administration has authorized the first two serology tests that report semi-quantitative data about past infection with SARS-CoV-2, the virus that causes COVID-19 infection.   “Being able to measure a patient’s relative level of antibodies in response to a previous SARS-CoV-2 infection may be useful as we continue to learn more about the virus and what the existence of antibodies may mean,” said Tim Stenzel, MD, PhD, director of the Office of In Vi...
  • ReconRecon

    Recon: Pfizer-US COVID vax deal details emerge; EC OKs Sanofi's aspart biosimilar

    ​Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.  In Focus: US US Price for Pfizer COVID Vaccine Includes Company Distribution Efforts Directed By DOD, CDC ( Pink Sheet ) J&J gets a fresh OK for esketamine, but is it really the game-changer for depression Trump keeps tweeting about? ( Endpoints ) Three More Experimental Therapies Receive Rare Pediatric Disease Designation by FDA ( Global Genes ) Kymera Therapeutics, fresh ...
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    FDA clarifies pooled sample, multi-analyte coronavirus EUAs

    Developers of multi-analyte respiratory panels that include a test for SARS-CoV-2, the novel coronavirus, can request emergency use authorizations (EUAs) from the US Food and Drug Administration (FDA), the agency clarified this week.   In updates to its frequently asked questions (FAQ) webpage on SARS-CoV-2 testing, the agency said that multi-analyte respiratory panels that include SARS-COV-2 are eligible for emergency use authorization, noting “the overlap in signs ...
  • Regulatory NewsRegulatory News

    FDA FY2021 user fee table

    The US Food and Drug Administration (FDA) has published the user fee amounts it will collect in FY2021 from manufacturers of pharmaceuticals, generic drugs, biosimilars, medical devices and outsourcing facilities. The table below lists the user fees for each program:   FDA User Fee Table FY2021 Prescription Drug User Fee Act (PDUFA VI) FY2021 FY2020 Change Applications:            Requiring clinical data $2,875,842 $2,942,965 -$67,123 ...
  • ReconRecon

    Recon: US to pay $2.1B for Sanofi, GSK COVID-19 vaccines; AbbVie, Gilead report Q2 results

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US US to pay $2.1B to Sanofi, GSK, in COVID-19 vaccine deal ( Reuters ) ( Politico ) ( NYTimes ) ( Press ) Trump planning for US rollout of coronavirus vaccine falling short, officials warn ( Reuters ) Large US COVID-19 vaccine trials will exclude pregnant women for now ( Reuters ) Merck plans large trials of antiviral COVID-19 drug in September ( Reuters ) Chin...
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    Glycolic acid, TCA among proposed additions to 503B bulk drugs list

    Four new bulk substances are up for inclusion on the list of active pharmaceutical ingredients that outsourcing facilities can use in drug compounding under section 503B of the Federal Food, Drug, and Cosmetic Act , according to a proposal from the US Food and Drug Administration (FDA).   The four substances FDA is proposing to include as bulk drug substances are diphenylcyclopropenone, glycolic acid, squaric acid dibutyl ester and trichloroacetic acid. An additiona...
  • ReconRecon

    Recon: J&J begins its first COVID-19 vaccine clinical trial; AstraZeneca reports rise in first-half profit

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers Race to Build Covid-19 Vaccine Supply Chains ( WSJ ) FDA could issue emergency use authorization for coronavirus vaccine in a matter of weeks ( CNN ) FDA Nears Decision Authorizing Covid-19 Treatment With Convalescent Plasma ( WSJ ) J&J starts human study of COVID-19 vaccine after promising monkey data ( Reuters ) ( FT ) ( NYTimes ) Inovio vaccine ...
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    FDA issues new unit-dose repackaging guidance

    Unit-dose repackaged oral solid medications will generally not be subject to US Food and Drug Administration (FDA) action regarding nonconformance with expiration date provisions, so long as certain requirements are met.   The agency issued the guidance in the context of the increasingly common practice of repackaging solid oral medications into unit-dose containers for hospitals and long-term care facilities. “The increase in unit dose repackaging has led to questions...
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    FDA issues at-home and OTC COVID-19 testing template

    Developers of COVID-19 diagnostic tests designed for at-home and over-the-counter use have a new template they can use to submit emergency use authorization (EUA) requests to the US Food and Drug Administration (FDA).   For at-home testing, the template includes recommendations for developers in the scenario where samples are collected, analyzed, and results returned without the sample being sent to a laboratory for analysis. Additional validation recommendations are...
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    FDA revises draft PLLR guidance

    The US Food and Drug Administration (FDA) on Wednesday revised its draft guidance providing recommendations on the content and format of labeling required under the pregnancy and lactation labeling rule (PLLR).   The draft guidance was first issued alongside the final PLLR in 2014, with the rule itself taking effect in June 2015. The PLLR revised labeling requirements under the 2006 physician labeling rule, to “provide a framework for clearly communicating information ...