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  • Regulatory NewsRegulatory News
    RAPS' LatestRAPS' Latest

    Orphan drug experts discuss new book on developing rare disease treatments

    Developing therapies for rare diseases involves complex incentives, unique requirements, and often extensive patient engagement. The authors of RAPS’ Orphan Drug Development for Rare Diseases , Sundar Ramanan, PhD, MBA, and Sunny Kamlesh Dave, MPharm, recently took time to discuss with RAPS Senior Editor Gloria Hall the importance of orphan drugs, the peculiarities and challenges of obtaining an orphan drug designation (ODD), and what is covered in the book. During a “m...
  • Regulatory NewsRegulatory News

    Stakeholders split over FDA’s contentious proposed rule for OTC hearing aids

    The US Food and Drug Administration (FDA) has received a number of comments over the past few months on its proposed rule that would create a new regulatory category for over-the-counter (OTC) hearing aids for adults with mild or moderate hearing loss.   The proposed rule was written in response to the Over-the-Counter Hearing Aid Act of 2017 passed as a provision of the FDA Reauthorization Act of 2017 . (RELATED: FDA issues proposed OTC hearing aid rule , Reg...
  • ReconRecon

    Recon: Pfizer gets conditional OK from EMA for Paxlovid; Moderna starts trial for Omicron booster shot

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Moderna starts trial for Omicron-specific booster shot ( Reuters ) Most US local governments opt to join $26 bln opioid settlement ( Reuters ) Roche nabs a priority review for Evrysdi, hoping to become the first oral treatment for infants with SMA ( Endpoints ) Pfizer pushes to intervene in lawsuit seeking COVID vaccine information from FDA ( Reuters ) ( Endpo...
  • Feature ArticlesFeature Articles

    Maximizing the potential of the FDA assessment aid: Genentech’s experience

    The assessment aid (AAid), an initiative of the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE), was introduced in 2018 as a pilot program to help streamline the agency’s review of oncology drug applications. In this article, Genentech shares its experience with the AAid to date and provides recommendations for preparing the AAid and improving the process to fully realize its benefits. Keywords – assessment aid, FDA OCE pilots, oncology dr...
  • RoundupsRoundups

    Euro Roundup: Swissmedic shortens time limits for reporting foreign safety signals

    The Swiss Agency for Therapeutic Products (Swissmedic) has cut the time limits for reporting signals that are classified as emerging safety issues. Under the new rules, marketing authorization holders have five days to report a signal and 15 days to bring the process to its conclusion.   Swissmedic is applying the new limit to emerging issues such as urgent procedures and safety-related referral procedures in the EU. The agency expects companies to report signals immed...
  • Regulatory NewsRegulatory News

    EU foresees reenergized clinical trial sector as new regulations take effect

    The delayed Clinical Trials Regulation (CTR) is set to take effect on Monday, 31 January, marking a milestone in the European Union’s attempt to improve transparency and boost the amount of human research that takes place in the region.   Currently, sponsors must file clinical trial applications to national regulators and ethics committees in each country that they want to include in their studies, then cope with multiple processes for registering their studies and pos...
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    Aurobindo warned for lax investigations, repeat GMP violations

    The US Food and Drug Administration (FDA) hit Indian drugmaker Aurobindo with a warning letter for inadequately investigating batch failures related to its manufacturing of active pharmaceutical ingredients (APIs) and for failing to evaluate the potential effect of changes on its intermediates and APIs.   The firm was warned for “significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients.”   The company’s Telanga, H...
  • RoundupsRoundups

    FDA Approvals Roundup: Kimmtrak, Skyrizi, Veklury

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approval Kimmtrak okayed for advanced uveal melanoma Immunocore’s Kimmtrak ( tebentafusp-tebn; injection ) has been approved for treating unresectable or metastatic uveal melanoma (mUM) in adults who are HLA-A*02:01 positive and have not received previous treatment. It is the first drug approved for this condition.   The approval was based on findings...
  • Regulatory NewsRegulatory News

    Industry calls for flexibility on RWD data sources, validation

    Industry leaders want to see more flexibility and clarity from the US Food and Drug Administration (FDA) as it seeks to finalize guidance on the use real-world data (RWD) from electronic health records (EHRs) and medical claims to support regulatory decision-making.   The comments were in response to the FDA’s draft guidance “Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products,” which was is...
  • Regulatory NewsRegulatory News

    FDA issues trio of guidances aimed at boosting generic competition, reducing review cycles

    The US Food and Drug Administration (FDA) on Wednesday issued three guidances – two final and one revised draft – aimed at clarifying aspects of generic drug submissions and labeling updates.   FDA said the guidances support its Drug Competition Action Plan (DCAP), which was first announced in 2017. (RELATED: Gottlieb looks to boost generic drug competition , Regulatory Focus 21 January 2017)   “These guidances are part of our continued efforts to bring greate...
  • ReconRecon

    Recon: FDA places partial hold on Gilead blood cancer drug trials; Senators propose pandemic preparedness overhaul

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US FDA hurries up a quick approval for the world's first TCR -- after a 14-year R&D trek ( Endpoints ) ( Pharmaphorum ) In a setback, FDA orders Gilead to hit the brakes on their late-stage, $5B cancer play ( Endpoints ) ( STAT ) ( Fierce ) ( BioPharma Dive ) Cortexyme switches direction, announces layoffs after FDA slaps hold on dark horse Alzheimer’s candidate (...
  • Regulatory NewsRegulatory News

    FDA finalizes guidances on PROs, patient engagement in device studies

    The US Food and Drug Administration (FDA) issued two final guidance documents on Tuesday that aim to help sponsors better incorporate and capture patients’ experiences in medical device clinical studies.   One guidance addresses best practices for selecting and modifying patient-reported outcomes (PROs) in medical device evaluations while the other document focuses on increasing patient engagement in clinical trials. Both contain minor revisions from earlier drafts...