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  • ReconRecon

    Recon: Takeda in for $900M on gene therapy R&D; Vertex gets quick win in England for CF triple therapy

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gottlieb says worst of outbreak will pass by January; Pence sees no need for a mask mandate ( CNBC ) Coronavirus Update: Spooked By America’s COVID-19 Vaccine Skepticism, FDA Promises Not To Lower Standards ( Scrip ) AHA: Hospital losses could top $323B in 2020 ( HealthLeaders ) 2020 Fortune/IBM Watson Health 100 Top Hospitals List ( HITConsultant ) EUSA P...
  • RoundupsRoundups

    FDA Approvals Roundup: Fintepla, Dojolvi, Phesgo

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Fintepla gets the go-ahead for Dravet syndrome Zogenix’s Fintepla (fenfluramine) has been approved for the treatment of seizures associated with Dravet syndrome in patients aged 2 years or older. The syndrome is a rare, life-threatening form of epilepsy.   The approval was based on findings from two clinical studies in 202 participants aged ...
  • Regulatory NewsRegulatory News

    FDA: Digital safety data submission to supplant PDFs

    After a successful pilot program, the US Food and Drug Administration (FDA) is fine-tuning a transition to all-digital submission of safety data from clinical trials of investigational drugs.   The goal is to modernize the submission of regulatory data by shifting from use of multiple PDF documents into a digital submission format with structured data elements “that will allow us both to improve the data quality and also allow us to use new analytic tools,” to make oth...
  • Feature ArticlesFeature Articles

    Regulatory Focus, June issue: Nutrition in health and disease management

    This month marks the fifth anniversary of the annual series on nutrition in health and disease management, initiated in 2016 by Manfred Ruthsatz , PhD, RAC, FRAPS (executive director, Nutrition+HealthCARE, Switzerland). Ruthsatz has led all five series to date, this year, together with co-lead, Andrea Wong , PhD (SVP, scientific and regulatory affairs, Council for Responsible Nutrition, Washington DC). They have coordinated authors and reviewers who are global leaders in...
  • Regulatory NewsRegulatory News

    Guidance: FDA holds off on enforcing certain UDI requirements

    The US Food and Drug Administration (FDA) has issued a final guidance for unique device identification compliance dates for Class I and unclassified medical devices. The immediately effective guidance also clarifies agency policy regarding compliance dates for certain devices requiring direct marking.   In the guidance, FDA clarifies that it does not currently intend to enforce standard date formatting, unique device identification (UDI) labeling, or Global Unique Devi...
  • Regulatory NewsRegulatory News

    Pediatric anti-infective development addressed by FDA

    The US Food and Drug Administration (FDA) has issued new draft guidance for sponsors who are developing anti-infective drug products for the pediatric population.   The draft guidance notes that pediatric drug development in general comes with some challenges, including the fact that differences not only in body size but also organ maturation and body fluid composition and distribution can affect drug pharmacokinetics and pharmacodynamics in children. Also, some infect...
  • Regulatory NewsRegulatory News

    FDA seeks input on genotyping for pediatric codeine use

    The US Food and Drug Administration (FDA) is seeking public consultation on whether children under the age of 12 years should be permitted to receive analgesics containing codeine, if they have been cleared from having a genetic tendency to metabolize the drug at potentially toxic levels.   Currently, the use of products containing codeine is contraindicated in children under the age of 12. Codeine, an opioid indicated for relief of mild to moderate pain under some cir...
  • Regulatory NewsRegulatory News

    FDA issues final guidance on inspections of medical device establishments

    The US Food and Drug Administration (FDA) today published finalized guidance on inspections of medical device establishments. The final guidance follows a 28 March 2019 draft guidance, satisfying a requirement of the FDA Reauthorization Act of 2017 (FDARA).   The FDARA provision directs FDA to issue guidance specifying how it will implement uniform processes and standards that apply to inspection of both foreign and domestic establishments, other than for-cause inspect...
  • Regulatory NewsRegulatory News

    Revise remdesivir EUA to add registry, say researchers

    The US Food and Drug Administration (FDA) should create a patient registry to track key information about COVID-19 patients treated with remdesivir, according to three Harvard Medical School researchers. The researchers also called for FDA to begin negotiations with Gilead, which markets remdesivir, about pricing for the antiviral drug.   In a Viewpoints article published yesterday in JAMA, Ameet Sarpatwari, PhD, JD, and coauthors noted that FDA’s 1 May emergency use...
  • Regulatory NewsRegulatory News

    FDA gives Project Renewal update at AACR

    Generic cytotoxic cancer drugs are a cornerstone of cancer therapy, but their labels may not reflect current best evidence regarding safety and effectiveness. Progress on a pilot FDA effort to modernize labels for these drug was shared by Patricia Keegan, MD, acting associate director for medical policy at the FDA’s Oncology Center of Excellence, at the virtual annual meeting of the American Association for Cancer Research.    Project Renewal, begun at the end of 2018,...
  • Regulatory NewsRegulatory News

    International regulators iron out COVID vaccine trial harmonization

    As more candidate vaccines for the novel coronavirus are progressing to advanced clinical trials, international regulators are planning for international convergence on the nuts and bolts of what is needed to move to phase 3 trials of COVID-19 vaccines. On Monday, a group of regulators were convened under the umbrella of the International Council of Medicines Regulatory Authories (ICMRA) for a multinational discussion. In all, 100 regulators from more than 20 countries ...
  • RoundupsRoundups

    FDA Approvals Roundup: Tazverik, Crysvita, Xpovio

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Tazverik extended as therapy for mutated follicular lymphoma Epizyme’s Tazverik (tazemetostat) has been granted accelerated approval for treating adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation, as detected by an FDA-approved companion diagnostic, the cobas EZH2 Mutation Test (Roche...