The Learning Portal will be under maintenance Saturday, 8 August between 6 AM and 6 PM EST. Portal functionality will be unavailable during this window.
We apologize for any inconvenience caused during this time.

RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

 
  • Regulatory NewsRegulatory News

    FDA provides guidance on preparation and submission of pediatric study plans

    In a final guidance document, the US Food and Drug Administration provides sponsors with a detailed framework for how to prepare and submit pediatric study plans. The final guidance supplants a draft guidance published in 2016.   The new pediatric study plan guidance follows on from regulations and laws promulgated in the late 1990s and early 2000s that addressed the dearth of pediatric data in drug development. These rules aimed to increase pediatric studies for exclu...
  • RoundupsRoundups

    FDA Approvals Roundup: Monjuvi, Spravato, Epidiolex

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Monjuvi okayed as novel therapy for diffuse large B-cell lymphoma MorphoSys’ Monjuvi (tafasitamab-cxix IV infusion) has been approved for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).   The novel CD19-directed cytolytic antibody is indicated in combination with lenalidomide for patients with DLBCL, i...
  • ReconRecon

    Recon: Abbvie cans pacts with Voyager; Bayer sees compounded troubles with COVID-19

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. In Focus: US Generic drug approvals still winning the pandemic at US FDA ( Pink Sheet ) BARDA Begins Stockpiling APIs For Critical Drugs ( Pink Sheet ) Report: GoodRx files for IPO ( MedCity News ) CymaBay Reports Positive Results for Seladelpar in Patients with Primary Biliary Cholangitis ( Global Genes ) BARDA drafts Fujifilm Diosynth into its vaccine production effort, of...
  • Regulatory NewsRegulatory News

    FDA touts advanced manufacturing to address COVID shortfalls

    Advanced manufacturing techniques can be employed to help address some of the manufacturing and supply chain problems the US has seen during the COVID-19 pandemic, Stephan Hahn, Food and Drug Administration (FDA) commissioner, and Anand Shah, FDA deputy commissioner for medical and scientific affairs, wrote in a blog post on the FDA website. “The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, whic...
  • 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...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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 ...
  • Regulatory NewsRegulatory News

    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...
  • Regulatory NewsRegulatory News

    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...