• Regulatory NewsRegulatory News

    FDA updates guidances to clarify new generic drug meeting requirements in GDUFA III

    The US Food and Drug Administration (FDA) has updated four guidances to address new commitments made in the latest Generic Drug User Fee Amendments (GDUFA III) program. The guidances revise ones issued under GDUFA II and clarify how the agency plans to hold up its end of the new user fee deal, which covers FY 2023 to FY 2017.   FDA updated a 2020 guidance on how it designates products as competitive generic therapies (CGT) to expedite certain generic products to mark...
  • Regulatory NewsRegulatory News

    FDA updates guidances to reflect new MDUFA goals

    FDA updates guidances for new MDUFA goals The US Food and Drug Administration has updated three guidances to reflect revised timelines for responding to premarket approval (PMA), 510(k) and de novo applications under the latest Medical Device User Fee Amendments (MDUFA V) program.   After Congress renewed FDA’s user fee programs in an eleventh-hour budget deal last month, the agency published several guidances on 3 October updating its committed goals under MDUFA...
  • Regulatory NewsRegulatory News

    FDA issues guidances on facility readiness and early DMF assessments under GDUFA III

    The US Food and Drug Administration’s (FDA) on 3 October released two draft guidances that implement new enhancements under the new Generic Drug User Fee Act (GDUFA III) program. One guidance covers FDA’s criteria for assigning a review goal date based on facility’s readiness for inspection, and the other addresses the early assessment of drug master files (DMFs) prior to the submission of generic drug applications.   These program enhancements were specified in the GD...
  • Regulatory NewsRegulatory News

    FDA offers details on PDUFA VII STAR review pilot

    The US Food and Drug Administration (FDA) has announced details on its Split Real Time Application Review (STAR) pilot, a program designed to shorten the review time of existing drugs and biologics where there is an unmet medical need so patients can access the therapies earlier.   The program would apply to “efficacy supplements across all therapeutic areas and review disciplines that meet specific criteria,” the agency wrote on a new web page. The program includes ...
  • Regulatory NewsRegulatory News

    ICH Q14: Pharma groups want clarity on benefits of enhanced approach

    Pharmaceutical industry groups questioned whether following the enhanced approach in International Council for Harmonization (ICH) Q14 guidance will confer regulatory relief for manufacturers that follow this method in developing an analytical procedure.   They also asked for recommendations for when an enhanced approach should be followed, called for greater alignment with the ICH Q2(R2) guideline and requested more examples showing multivariate approaches to analytic...
  • ReconRecon

    Recon: FDA warns Evusheld ineffective against emerging Omicron subvariant; Production woes prompt Takeda to discontinue hypoparathyroidism drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Another one bites the dust? FDA warns that emerging Omicron subvariant could make Evusheld obsolete ( Endpoints ) ( Fierce ) Another warning letter for Lupin as FDA identifies deficiencies at India-based site ( Endpoints ) Califf: FDA Launches External Review Into FDA’s Handling of Approved Opioids ( FDAnews ) US FDA Still Hasn’t Decided Who Will Be Final Arbi...
  • RoundupsRoundups

    Asia-Pacific Roundup: Philippine FDA seeks feedback on streamlining regulatory filing process

    The Philippine Food and Drug Administration (FDA) is running a consultation about planned changes to its application system and documentary requirements for pre-license filings.   FDA has two goals for the changes: to further reengineer and streamline its processes and automate its system for initial, renewal and variation application for license to operate (LTO) through the eServices Portal System; and to update the list of documentary requirements for pre-license app...
  • Regulatory NewsRegulatory News

    FDA acknowledges shortcomings of Pre-Cert pilot in report

    The US Food and Drug Administration (FDA) said it needs additional Congressional authority to move forward with its digital health precertification (Pre-Cert) program. While the idea has been widely lauded by various stakeholders, at least one expert said he feels vindicated for warning the agency early on that it lacked the legal authority to fully implement pathway.   In 2017, the FDA proposed the idea of a Pre-Cert program that would act as a new pathway for softwar...
  • Regulatory NewsRegulatory News

    Stakeholders want more clarity on concepts introduced in third PFDD draft guidance

    The US Food and Drug Administration (FDA) received a broad range of comments concerning its draft guidance on selecting, developing, or modifying clinical outcome assessments (COA) in patient-focused drug development (PFDD), with most stakeholders wanting to know how new terminology introduced in the guidance would fit in with the agency’s overall PFDD program.   FDA’s draft guidance on COAs for PFDD is the third in a series of four guidances authored by staff members ...
  • ReconRecon

    Recon: FDA approves Otsuka subsidiary’s bile duct cancer drug Lytgobi; AstraZeneca buys LogicBio for $67M to grow genomics pipeline

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Otsuka’s Taiho Oncology bags approval for bile duct cancer med Lytgobi, teeing up showdown with BridgeBio and Incyte ( Fierce ) (Endpoints ) ( Pharma Letter ) Advocates, experts cry foul over Amylyx's new ALS drug, citing issues with price, PhIII commitment ( Endpoints ) ( Reuters ) ( BioPharma Dive ) Allogene Frustrated By FDA’s Delayed CAR-T Trial Review ( S...
  • This Week at FDAThis Week at FDA

    This Week at FDA: User fee reauthorization, Amylyx ALS drug approved, 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. Just hours ago, the House voted 230-201 to approve a stopgap funding bill that will reauthorize FDA’s user fee programs for the next five years.   The news comes as a relief to FDA and the medical product manufacturers who spent months negotiating the user fee deals. The user fee p...
  • RF Quarterly

    RF Quarterly, September 2022: Regulatory strategy

    Welcome to the September issue of RF Quarterly in which global regulatory experts write about the key elements of regulatory strategy throughout the product lifecycle, CMS regulatory strategy, the application of project management strategies to postapproval CMC submissions, and medical writing strategies for aligning regulatory documents with strategic goals.   We thank the authors for their generosity in sharing their knowledge and expertise with the RAPS regulatory c...