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  • Feature ArticlesFeature Articles

    Regulatory considerations for EUA during the COVID-19 public health emergency for medical device manufacturers

    This article examines regulatory considerations for emergency use authorizations for medical device manufacturers in response to the COVID-19 pandemic. The authors summarize the four phases of issuance as:  phase 1 ‒ in vitro diagnostic products; phase 2 ‒ personal protective equipment; phase 3 ‒ ventilators and components; and phase 4 ‒ other relevant medical devices. They emphasize the EUA is subject to statutory limits tied to the end of the public health emergency and ...
  • ReconRecon

    Recon: Gilead to begin trials of inhaled version of remdesivir; FDA rejects Nabriva’s antibiotic for the second time

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Gilead to Begin Human Testing of Inhaled Version of Covid-19 Drug Remdesivir ( WSJ ) FDA rejects Nabriva a second time; Nabriva pins it on travel restrictions ( Endpoints ) Rules for Clinical Trials in a Pandemic ( WSJ ) CDC coronavirus test kits were likely contaminated, federal review confirms ( Washington Post ) Efforts for Coronavirus Vaccine Focus on Vul...
  • Regulatory NewsRegulatory News

    FDA: Follow CDC guidance for COVID-infected employees

    A new guidance from the US Food and Drug Administration clarifies how manufacturers of drugs and biological products should address COVID-19 infection in their employees.   Generally speaking, employees who are ill or infected with SARS-CoV-2, the novel coronavirus, must be excluded from drug manufacturing areas and not permitted to return until they have met home isolation criteria established by the US Centers for Disease Control and Prevention (CDC). This guidance h...
  • ReconRecon

    Recon: FDA nods for Ultragenyx, Epizyme; Roche posts mixed results in late-stage prostate cancer trial

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Ultragenyx's Crysvita scores FDA nod in 2nd ultra-rare bone disorder ( Fierce ) ( FDA ) Epizyme wins second OK for Tazverik, in follicular lymphoma ( Endpoints ) ( FDA ) US biotech group to trial Covid-19 pill for use at home ( Financial Times ) Rush for Generic Go-Ahead on Novel Drugs Roils Pharma Industry ( Bloomberg ) Coronavirus Attacks the Lungs. A Feder...
  • Regulatory NewsRegulatory News

    FDA sends first warning letters for fraudulent marketing of antibody tests

    The US Food and Drug Administration this week issued its first set of warning letters for marketing adulterated or misbranded COVID-19 antibody tests.   The letters, sent to Medakit Ltd. of Hong Kong,  Antibodiescheck.com of United Arab Emirates, and Sonrisa Family Dental dba www.mycovidtest19.com of Chicago, cited a range of violations. These included offering test kits for sale in the US directly to consumers for at-home use without marketing approval, cleara...
  • Regulatory NewsRegulatory News

    Biopharma industry urges MRA to mitigate risk of no-deal Brexit

    The biopharma industry is urging the European Union to separate talks about post-Brexit regulatory cooperation from broader political negotiations. Groups including the European Federation of Pharmaceutical Industries and Associations (EFPIA) made the plea amid fears the collapse of free trade talks will force a hard split between the United Kingdom and EU regulatory regimes.   In a letter to senior EU officials, the six trade groups call for Brexit negotiators to pr...
  • Regulatory NewsRegulatory News

    FDA officials update on orphan drugs, gene therapies at DIA

    Officials from the US Food and Drug Administration (FDA) discussed the agency’s recent efforts to support the development of products to treat rare diseases during a session at DIA’s Global Annual Meeting on Wednesday.   Orphan and rare pediatric disease designations   While the number of products approved to treat rare diseases has increased over the last decade, the vast majority of rare diseases lack approved treatment options.   Janet Maynard, director of F...
  • Regulatory NewsRegulatory News

    European Commission proposes relaxing GMO regs for COVID-19 vaccines

    A proposal to adjust European Union regulation of genetically modified organisms (GMOs) would relax requirements for vaccines under development for SARS-CoV-2, the virus responsible for the novel coronavirus pandemic. The proposed derogation would allow GMO-containing candidate vaccines and coronavirus therapeutics to proceed with clinical trials.   “The policy objective of this proposed regulation is to ensure that clinical trials with medicinal products for human use...
  • RoundupsRoundups

    EU Regulatory Roundup: Noncompliance actions against Indian drugmakers drop to new low

    The number of European manufacturing noncompliance notices sent to Indian drugmakers fell to a new low last year, with just one good manufacturing practice (GMP) notice issued to an Indian company in 2019 compared to at least five annually over the previous four years, the European Medicines Agency (EMA) reported.   Indian drugmakers received a significant minority of all the GMP noncompliance notices issued by regulators in the European Economic Area (EEA) from 2015 t...
  • Regulatory NewsRegulatory News

    New accelerator to boost real-world COVID-19 diagnostics

    A collaboration to use real-world diagnostics evidence will seek to answer key questions about the novel coronavirus, including epidemiologic patterns, individual risk factors, and characteristics of immunity that might develop after infection with COVID-19.    The Diagnostics Evidence Accelerator is a joint project between the Reagan-Udall Foundation for the Food and Drug Administration and the nonprofit Friends of Cancer Research ; more than 50 collaborators were ...
  • ReconRecon

    Recon: EU in talks to reserve J&J COVID-19 vaccine; Pfizer gene therapy shows sustained effect in hemophilia study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Drugmakers Have Even Less Reason to Fear Price Reform Now ( Bloomberg ) Gilead to enroll pediatric patients for late-stage remdesivir study ( Reuters ) Pfizer's hemophilia gene therapy shows sustained effect in early-stage study ( Reuters ) ( Endpoints ) ( Press ) Trump pushing officials to speed up already-ambitious coronavirus vaccine timeline ( Washington P...
  • Feature ArticlesFeature Articles

    Dietary supplement class actions: Recent overlap with traditional FDA enforcement

    This article provides an overview of class action lawsuits targeting the dietary supplement industry. Recent trends indicate that companies should look beyond regulatory compliance and consider how a “reasonable consumer” would interpret claims in labeling, even claims that comply with FDA requirements. There are also important steps companies can take to prevent these lawsuits, as well as defenses that courts seem increasingly willing to accept. By staying aware of the cl...