• Regulatory NewsRegulatory News

    FDA continues data modernization with new Office of Digital Transformation

    The US Food and Drug Administration (FDA) is moving forward in plans to modernize its data and information technology efforts with the launch of a new Office of Digital Transformation (ODT).   “Good data management, built into all of our work, ultimately helps us meet and advance the FDA’s mission to ensure safe and effective products for American families,” said acting FDA commissioner Janet Woodcock, in a Wednesday press release announcing the newest step in its te...
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    Convergence: Manufacturers failing to grasp ‘step change’ in requirements under MDR

    Some manufacturers are failing to grasp the step change in clinical and risk management requirements imposed by the Medical Devices Regulation (MDR), Kevin Butcher told attendees at RAPS Convergence 2021.   Butcher, principal regulatory consultant at medical device contract research organization NAMSA, used his presentation at the event to discuss his practical experience of the challenges the European Union legislation is creating for the industry. The session focused...
  • RoundupsRoundups

    Euro Roundup: MedTech Europe warns 75% of diagnostics may lack IVDR certification by deadline

    MedTech Europe has estimated as few as one-quarter of currently available in vitro diagnostics (IVDs) will be certified under the incoming regulations by the time they take effect next year. The trade group based its forecast on a survey of IVD manufacturers.   Many IVDs will need to be certified by notified bodies for the first time under the new regulations. With a small pool of notified bodies available to do the work, MedTech Europe has repeatedly raised concerns t...
  • ReconRecon

    Recon: FDA approves Takeda's lung cancer therapy; Moderna makes its case for boosters

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna says COVID-19 vaccine protection wanes, makes case for booster ( Reuters ) U.S. Booster Policy Is in Flux as Studies Add to Dissent ( NYTimes ) U.S. FDA approves Takeda's lung cancer therapy ( Reuters ) ( FDA ) Drug Plan Fails, Signaling Thorny Path for Democrats’ $3.5 Trillion Bill ( NYTimes ) PhRMA launches 7-figure ad campaign against Democrats' dr...
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    In advance of adcomm, Pfizer makes its case for Comirnaty booster

    In briefing documents made available on Wednesday in advance of a US Food and Drug Administration (FDA) meeting, Pfizer made the case that a third dose of its COVID-19 vaccine would address an unmet public health need in the face of high and persistent levels of Delta variant breakthrough infections among the vaccinated.   Pfizer’s application for a supplemental biologics license application (sBLA) for Comirnaty, the messenger RNA (mRNA) COVID-19 vaccine it co-develope...
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    RAPS' LatestRAPS' Latest

    RAPS Convergence 2021 brings regulatory community together virtually to hear from regulators, learn from each other and celebrate the profession

    RAPS today wrapped up its annual RAPS Convergence , the world’s largest conference dedicated to healthcare product regulation and regulatory issues. The event drew more than 1,500 participants again this year—from 37 countries around the globe—in the second year it was held virtually. Convergence 2021 attendees heard from more than 300 expert speakers, including more than 50 from national and regional health authorities and notified bodies from around the world. More t...
  • Regulatory NewsRegulatory News

    FDA, EMA launch complex generic, hybrid product advice pilot

    The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) on Wednesday launched a new pilot aimed at giving parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the EU.   FDA says the pilot is an expansion of the two agencies' existing parallel scientific advice programs for new drugs and biologics. The tenets for the pilot and details regarding the process and procedures are laid ou...
  • Regulatory NewsRegulatory News

    Convergence: Inadequate testing of cell and gene therapies draws FDA concern

    The lack of consistent testing in measuring product quality for cell and gene therapies is a major deficiency found by US Food and Drug Administration (FDA) reviewers in its information requests (IRs) to manufacturers in their submission of biologics license applications (BLAs).   This observation was made by Kedest Tadesse, senior research manager for Agency IQ, which recently compiled a survey of deficiencies identified in IR letters in FDA’s review of five approved ...
  • RoundupsRoundups

    FDA Approvals Roundup: Brukinsa

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New indications Brukinsa nabs accelerated approval for previously treated marginal zone lymphoma BeiGene’s Brukinsa (zanubrutinib) has received accelerated approval for expanded use in treating relapsed or refractory  marginal zone lymphoma (MZL) in previously treated adults.   Approval of Brukinsa was based on efficacy findings from two single-arm clin...
  • ReconRecon

    Recon: US buys additional doses of Lilly, Regeneron antibodies; Centrists throw wrench in House Dems' drug pricing plans

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA staff say Pfizer COVID-19 boosters improve immunity but may not be needed ( Reuters ) Pfizer says third COVID-19 shot warranted in FDA document ( Reuters ) Biden to meet US CEOs in 'rallying cry' for vaccine mandates ( Reuters ) Centrists throw wrench in House Democrats’ drug pricing plans ( Politico ) ( STAT ) ( NYTimes ) Key senator opposes Democrats’ t...
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    Global regulatory workforce nearly 100K, says new report from RAPS, Elemed

    Nearly 100,000 professionals around the world currently work in the field of regulatory affairs for healthcare products, such as pharmaceuticals, medical devices, and biotechnology products, including vaccines. This is according to a new joint report from RAPS and Elemed , a leading technical recruiter specializing in regulatory affairs. The Global Regulatory Affairs Professionals Workforce report, previewed this week at the RAPS Convergence 2021 virtual conference...
  • Feature ArticlesFeature Articles

    Fostering diversity and talent: A Pfizer case study

    The Pfizer Global Regulatory Affairs (GRA) – Howard University College of Pharmacy (HUCOP) Advanced Pharmacy Practice Experience (APPE) program fulfills a requirement of the Doctor of Pharmacy (PharmD) curriculum and helps students explore biopharmaceutical industry career options and prepare for their career after graduation, such as pursuing postgraduate training and seeking employment. The HUCOP Preceptorship Program at Pfizer was designed to broadly increase awareness ...