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    Convergence: DARWIN EU real-world research network takes first steps

    PHOENIX, AZ – DARWIN EU, the Data Analysis and Real World Interrogation Network formed by the European Medicines Agency (EMA), is taking its first steps as a sustainable network for the generation of real-world evidence to support regulatory decision making in the European Union. “Currently, we are onboarding the data partners and working on the protocols and initiation of the first studies,” Andrej Segec, the DARWIN EU project manager at the EMA, told attendees at RAPS...
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    Nitrosamines in pharmaceuticals: Scientific and regulatory status

    Nitrosamines in pharmaceuticals have been of special concern since their presence at unacceptable levels in popular medicines was highlighted in 2018. Since then, improved understanding of their chemistry has enhanced the risk assessments, testing, and mitigation steps required to help minimize nitrosamine contamination in drug substances, excipients, and drug products. In addition, regulatory authorities have largely harmonized requirements and allowable limits in their r...
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    Convergence: EU official says no delay to CTIS implementation, despite industry concerns

    PHOENIX, AZ – Country-specific requirements that diverge from the Clinical Trials Regulation (CTR) and the lack of a forum for resolving issues with the Clinical Trial Information System (CTIS) portal were among the key issues industry representatives brought to a session at RAPS Convergence 2022.   Another problem is that the portal does not flag or send information to sponsors when new information is received, so sponsors must check frequently for updates.   In t...
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    Convergence: CDRH will continue with MDUFA V plan even with user fee delay

    PHOENIX, AZ – The US Food and Drug Administration’s device center will operate based on the Medical Device User Fee Amendment (MDUFA V) deal negotiated with industry even if Congressional lawmakers fail to pass the legislation on time. The center has enough carryover funds to take it into the new year by when it hopes a bill will be signed into law.   The various medical user fee programs are set to expire at the end of fiscal year 2022 (30 September) if Congress does ...
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    Euro Roundup: Working group posts MDR, IVDR manual on borderline devices

    The Borderline and Classification Working Group (BCWG) has created a manual for determining whether a product is classed as a medical device under the new regulations. BCWG developed the document as part of an attempt to prevent member states from having different interpretations of the legislation.   The manual records the agreements reached by members of BCWG covering the qualification of products at the borderline of different categories, such as medical devices and...
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    Recon: Pfizer to seek FDA approval for meningococcal vaccine after phase 3 success; Swiss agency probing Novartis in patent investigation

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Pfizer gears up to submit meningococcal shot for approval this year after phase 3 success ( Fierce ) ( Biospace ) U.S. to spend more than $2 billion to launch Biden’s biomanufacturing initiative  ( Biospace ) ( STAT ) Crunch time for FDA user fees as reauthorization looks to hitch a ride on short-term spending bill ( Endpoints ) Government-paid experts helping...
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    FDA issues final rule on ‘right to try’ reporting requirements

    Drug firms that agree to supply investigational medicines under the Right to Try Act must submit an annual summary detailing each use to FDA under a final rule issued this week.   The final rule specifies that manufacturers include details of the number of doses supplied, the number of patients treated, the use for which the drug was made available and any known serious adverse events that take place.   The rule also establishes when manufacturers need to submi...
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    Convergence: FDA officials on future COVID vaccine updates, remote inspections and hiring

    PHOENIX, AZ – The US Food and Drug Administration would like to adopt an annual update process for the COVID-19 vaccine, according to Peter Marks, director of the Center for Biologics Evaluation and Research (CBER). Such a process he said will help health officials, manufacturers and others better coordinate efforts to fight the SARS-CoV-2 virus as it evolves.   Speaking on a panel alongside other FDA officials including Peter Stein, director of the Office of New Drugs...
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    Convergence: Marks admits 'knucklehead' messaging missteps with bivalent boosters, touts RWE for vaccines

    PHOENIX, AZ – The US Food and Drug Administration’s (FDA) top vaccines regulator, Peter Marks, director of the Center for Biologics Evaluation and Research (CBER), said that the agency could have better communicated the strength of the evidence it had in support of the bivalent mRNA COVID-19 vaccine boosters it authorized last month.   Since authorizing the updated vaccines, the agency has faced criticism for authorizing the vaccines without requiring new clinical tria...
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    RAPS' LatestRAPS' Latest

    1,700 Gather in Phoenix for RAPS Convergence 2022

    The Regulatory Affairs Professionals Society (RAPS) concluded its annual RAPS Convergence in Phoenix on Tuesday, 13 September, attracting 1,700 participants from 41 countries across five continents. Attendees gathered in-person for the first time since 2019 for four days of educational sessions, expert presentations and panel discussions exploring the most pressing topics in medical device, IVD and pharmaceutical regulation for global markets.   “In addition to the p...
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    Convergence: FDA official urges big-picture focus in diversity planning for clinical trials

    PHOENIX, AZ – Medical product sponsors should focus on the overarching goal of enrolling diverse patient populations in clinical trials, rather than getting bogged down in differing terminology around race and ethnicity, according to Lola Fashoyin-Aje, MD, of the US Food and Drug Administration’s Oncology Center of Excellence.   “The big picture here is that we want to enroll a population that reflects the diversity of the population that will use the drug once it’s ap...
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    Convergence: Upfront planning, communication critical to ensuring success in real-time oncology reviews

    PHOENIX, AZ – Developing an application through FDA’s real-time oncology review (RTOR) program is a labor-intensive process. Companies should have an “all-hands on deck mentality” as soon as clinical data becomes available and be prepared to answer questions from the US Food and Drug Administration (FDA) quickly, said panelists at a session on FDA oncology initiatives on a 13 September at RAPS Convergence 2022.   During the discussion, an industry expert said the benef...