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  • 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    The US Food and Drug Administration (FDA) issued draft guidance documents on drug development for ulcerative colitis (UC) and Crohn’s disease, outlining recommendations on clinical trial design.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...
  • 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...
  • ReconRecon

    Recon: Moderna requests vaccine EUA for children under 6; Pfizer to begin US trial of Duchenne gene therapy as FDA lifts hold

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna files for US authorization of COVID shot for kids under 6 ( Reuters ) ( Endpoints ) ( Biospace ) Pfizer can restart PhIII trial of Duchenne gene therapy, now on par for late-2023 FDA approval request  ( Endpoints ) ( Reuters ) ( Fierce ) ( BioSpace ) IRS seeks more than $7B in back taxes and penalties from Amgen for shifting profits to Puerto Rico ( End...
  • Regulatory NewsRegulatory News

    MDCG issues guidance to help define ‘borderline’ products

    Developers struggling to decide whether their products are drugs or devices now have clearer definitions thanks to new guidance issued by the European Commission’s Medical Device Coordination Group (MDCG).   In general, determining whether a product is a device covered by the Medical Devices Regulation 2017/745 or a medicine covered by Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) is straightforward.   For other pro...
  • Regulatory NewsRegulatory News

    FDA official discusses common deficiencies derailing ANDAs

    The US Food and Drug Administration (FDA) rejected a fewer number of abbreviated new drug applications (ANDAs) in FY 2021 through its refuse-to-receive (RTR) mechanism compared to previous years, said Peter Enos, a reviewer with the agency’s Office of Generic Drugs. He attributed the improvement to increased transparency with industry, better filing practices and enhanced communication with applicants.   Enos also addressed how industry can improve their submissions to...
  • Regulatory NewsRegulatory News

    FDA finalizes electronic postmarketing safety reporting guidance

    The US Food and Drug Administration (FDA) has finalized guidance that outlines how postmarketing safety reports for drugs and biologics should be submitted electronically. The guidance follows a final rule and corresponding draft guidance issued by the agency in 2014 to streamline the safety reporting process.   On 27 April FDA published the Providing Submissions in Electronic Format—Postmarketing Safety Reports final guidance. The draft version was published in 20...