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  • ReconRecon

    Recon: Merck strikes deal with Yumanity for neurodegenerative disease drugs; Feds allege Regeneron used charity to pay kickbacks

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Federal prosecutors allege Regeneron used a charity to pay kickbacks to Medicare patients ( STAT ) Yumanity Therapeutics, Merck strike deal aimed at developing new medicines for neurodegenerative disease ( STAT ) ( Endpoints ) FDA urged to heighten safety warnings on common type 2 diabetes drugs ( STAT ) ( Public Citizen ) By $4M, La Jolla outbids Melinta for ...
  • Feature ArticlesFeature Articles

    Regulatory considerations for FDA enforcement policies during the COVID-19 public health emergency for medical device manufacturers

    This article summarizes FDA enforcement policy during the early months of the COVID-19 public health emergency and outlines the regulatory considerations for temporary enforcement discretions. The authors emphasize the importance of routine and scientific communication between the FDA, industry, and providers to facilitate the long-term directions of these technologies.   Introduction Historically, the US Food and Drug Administration (FDA) has played an important rol...
  • Regulatory NewsRegulatory News

    AACR: Minority accrual in clinical trials is a team sport

    Those who conduct clinical trials are missing a broad swath of the US population, with implications that not only reach into issues of equity and justice, but may also limit the generalizability of study findings, said a cancer researcher speaking at the American Association for Cancer Research annual meeting.   “Without adequate minority representation, it is difficult for us to fully be able to generalize the effects regarding the toxicity or efficacy or a medication...
  • Regulatory NewsRegulatory News

    Hahn testifies on COVID-19 response, says FDA on target to hit user fee goals

    US Food and Drug Administration (FDA) Commissioner Stephen Hahn, MD, on Tuesday testified before the House Energy and Commerce Committee on his agency’s response to the coronavirus disease (COVID-19) pandemic.   User fee goals, policy review   Despite an “incredible surge in volume” of applications and constraints on the agency’s ability to conduct inspections, Hahn said that FDA, “Has maintained the same pace of meeting its goals on applications for medical produc...
  • Regulatory NewsRegulatory News

    EMA offers free orphan drug advising to academia

    Academic organizations working on drug development for rare diseases will now be eligible for waiver of fees for scientific advice from the European Medicines Agency (EMA), according to an updated Executive Decision issued by the agency. “The academic sector plays an important role in the development of innovative medicines. Their scientific research is often at the source of novel methodologies and innovative medicines with the potential to benefit patients with rare d...
  • Feature ArticlesFeature Articles

    Update on trade issues affecting the dietary supplement industry

    This article discusses recent updates on US trade policy issues in the dietary supplement industry. It focuses on the trading relationship between the US and its largest trading partners, including China, and analyzes the ongoing effects of current trade policies on companies that produce, buy, and sell dietary supplements. The authors discuss tools available to US companies to reduce financial liability when trade policies are evolving at a rapid pace.   Introduction ...
  • RoundupsRoundups

    Asia Regulatory Roundup: COVID-19 drives Australia to propose delay to medical device reforms

    Australian medical device reforms could be delayed until next year to give the industry more time to prepare, considering the effect COVID-19 has had on preparations.   Under the current timeline, Australia would implement a raft of reforms to its medical device rules on 25 August. If enacted, the delay will push the implementation of reforms to the regulation of medical device software and personalized medical devices back to 25 February 2021. The government is also p...
  • ReconRecon

    Recon: Sanofi accelerates COVID-19 vaccine plans; Gilead inks $1.5B buyout deal for Pionyr

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US The new Janet: The FDA turns to a quiet problem-solver who brings expertise — and a little controversy ( STAT ) Lawmakers push Covid-19 bills to prevent price gouging, track federal funds used to discover drugs ( STAT ) As approval decision nears, fate of Intercept’s NASH drug clouded by murky FDA review delays ( STAT ) Gilead pens $1.5B buyout option deal for...
  • FDA to sponsors: Early communication key during COVID-19

    Virtual meetings – a staple of business life during the COVID-19 pandemic – are an option for sponsors who seek meetings with the US Food and Drug Administration. Best routes of communication with the FDA both for coronavirus-related and other submissions and tips for having productive virtual meetings were shared with attendees of the virtual DIA 2020 global annual meeting by Khushboo Sharma, deputy director of operations at the Office of New Drugs at FDA’s Center for Dru...
  • Regulatory NewsRegulatory News

    Lawmakers ask FDA to outline COVID-19 vaccine approval process

    Key Democratic members in the US House of Representatives have called on Stephen Hahn, MD, commissioner of the US Food and Drug Administration (FDA), to brief their staff on how the agency plans to make decisions regarding the development, review and deployment of vaccines against the novel coronavirus SARS-CoV-2.   In a letter dated 18 June, Rep. Carolyn Maloney (D-NY), chairwoman of the House Committee on Oversight and Reform, Rep. Raja Krishnamoorthi (D-IL), chairma...
  • Regulatory NewsRegulatory News

    New priorities set for trans-Atlantic collaboration on medicines

    As part of an annual bilateral regulatory dialog, officials from the European Commission (EC), the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) agreed on priorities for collaboration.   “In the context of the  COVID-19 pandemic , the EC, EMA and FDA have further intensified their collaboration through regular interactions, notably under the umbrella of the International Coalition of Medicines Regulatory Authorities (ICMRA),” said EMA in...
  • Regulatory NewsRegulatory News

    FDA explains COVID-19 impact on MDUFA goals, meetings

    The US Food and Drug Administration (FDA) on Monday issued an immediately effective questions and answers guidance explaining the impact of the coronavirus disease (COVID-19) public health emergency on formal meetings and applications for medical devices.   FDA released a similar guidance pertaining to formal meetings and applications for drugs and biologics amid the pandemic in late May. (RELATED: FDA explains impact of COVID-19 on applications, formal meetings , ...