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  • Regulatory NewsRegulatory News

    FDA's use of adcomms prior to drug approval decreased over the last decade

    Between 2011 and 2021, the US Food and Drug Administration (FDA) decreased the use of advisory committees before approving drugs from 59% to 6% per year, according to recent research published in Health Affairs .   “Advisory committees, if used consistently, can lend credibility to the FDA’s decision to allow a drug to market. But the decrease we found in advisory committee review of approved drugs since 2010 presents concerns about how FDA is choosing to use—or not u...
  • ReconRecon

    Recon: Biogen CEO to step down as drugmaker curbs spending on Alzheimer’s drug; FDA restructures device center, adding two health tech offices

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Another Pfizer gene therapy is free of FDA hold, but delay continues ( Fierce ) A year after CRL, Acadia is going back to bat for Nuplazid at the FDA ( Endpoints ) As expected, FDA spikes down Axsome migraine med, but issues are ‘addressable’ ( Fierce ) Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill ( The Pink She...
  • RoundupsRoundups

    Asia-Pacific Roundup: TGA provisional determination for Moderna’s bivalent COVID vaccine

    Australia’s Therapeutic Goods Administration (TGA) has granted provisional determination to a bivalent Moderna COVID-19 vaccine that is designed to protect against the original, wild-type strain of SARS-CoV-2as well as the Omicron variant.   Moderna began developing bivalent vaccines as SARS-Cov-2 started taking hold in parts of the world. The vaccines use two pieces of mRNA, one encoding for the spike protein of the original strain, another encoding for the spike prot...
  • Regulatory NewsRegulatory News

    FDA’s Office of Compliance details enforcement actions in 2021

    The US Food and Drug Administration (FDA) Office of Compliance (OCC) issued numerous enforcement discretion decisions to increase supplies of critically needed medicines for treating COVID-19 and increasingly relied on the use of inspection alternatives, such as product sampling and reviewing firms’ written response to records, instead of traditional onsite inspections in 2021.   These are some of the areas highlighted in OCC’s latest annual report released 2 May, de...
  • Regulatory NewsRegulatory News

    FDA offers guidance on drug development for ulcerative colitis, Crohn’s disease

    The US Food and Drug Administration (FDA) issued draft guidance documents on drug development for ulcerative colitis (UC) and Crohn’s disease, outlining recommendations on clinical trial design. Both UC and Crohn’s disease are chronic inflammatory bowel diseases. In the current guidance documents, issued on 29 April 2022, agency officials outline their thinking on clinical trial populations, trial designs, efficacy considerations, and safety assessments. The guidance fo...
  • ReconRecon

    Recon: Pfizer’s Paxlovid fails to show benefit for COVID prevention; FDA places hold on Vertex’s diabetes study

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer says COVID treatment Paxlovid fails to prevent infection of household members ( Reuters ) ( STAT ) Vertex Falls After FDA Halts Diabetes Study in Surprise Move ( Endpoints ) ( STAT ) It’s CRL Day at the FDA as Axsome, Junshi and Coherus Get Bad News ( Biospace ) Human testing for Praxis’ lead epilepsy drug held up after FDA clinical hold ( Endpoints ) ...
  • Feature ArticlesFeature Articles

    Regulatory specialist, generalist, or generalized specialist: Weighing the options

    This article explores the role of a generalist and a specialist within the regulatory profession, as well as considerations in today's evolving regulatory landscape. To decide on the best path forward, it is important to understand current global market expectations from the regulatory profession, as well as compensation depending on job level and education in the healthcare sector.   Keywords – generalist, generalized specialist, professional development, skill set...
  • This Week at FDAThis Week at FDA

    This Week at FDA: A busy week on the Hill, VRBPAC’s June meeting bonanza, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This was a busy week for FDA in Congress, with hearings in both chambers touching on FDA’s user fee programs, FY2023 budget request, and more. We also saw FDA release a tentative schedule for several upcoming advisory committee meetings to discuss COVID-19 vaccines. Plus, we learned that ...
  • Regulatory NewsRegulatory News

    Remote interactive evaluations: FDA official discusses lessons learned

    To ensure the success of remote interactive evaluations (RIEs), the pharmaceutical industry should treat these evaluations with the same level of attention to detail as onsite inspections,  said Alexander Gontcharov, a staff fellow with the US Food and Drug Administration’s (FDA) Office of Pharmaceutical Quality (OPQ) during the second day of FDA’s Generic Drug Forum on 27 April.   At the meeting, Gontcharov shared some of the lessons learned from the agency’s intera...
  • TrackersTrackers

    COVID-19 therapeutics tracker

    A handful of therapeutics have been approved specifically to treat COVID-19, reduce its severity, or prevent it entirely. Among those treatments are dexamethasone, Avigan (favilavir), Veklury (remdesivir) alone and in combination with Olumiant (baricitinib), Lagevrio (molnupiravir), Xevudy (sotrovimab), Regkirona (regdanvimab), Ronapreve (casirivimab and imdevimab), amubarvimab and romlusevimab (formerly BRII-196 and BRII-198), Actemra/RoActemra (tocilizumab), Paxlovid (ni...
  • Regulatory NewsRegulatory News

    Califf wants to create incentives for FDA commissioners to stay longer

    High commissioner turnover and difficulty attracting young leaders are undermining staff stability and confidence at the US Food and Drug Administration, Commissioner Robert Califf told a Senate subcommittee hearing on the agency’s FY 2023 budget.   The Senate Appropriations Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies met on 28 April to talk about the FDA’s proposed FY 2023 budget. But instead of talking directly...
  • RoundupsRoundups

    Euro Roundup: Commission seeks 5-year extension MDR/IVDR delegated acts powers

    The European Commission is seeking a five-year extension of the power to adopt delegated acts related to the new medical device and in vitro diagnostic regulations (MDR/IVDR). Officials said that an extension is needed because flexibility will be required as science advances and experience of the rules increases.   When the two regulations entered into force in 2017, the Commission gained the power to adopt several delegated acts. The power was scheduled to last for fi...