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  • Regulatory NewsRegulatory News

    Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method

    A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to address this issue from a good manufacturing practices (GMP) standpoint, and not a compendial approach as espoused in the US Pharmacopoeia’s (USP) Chapter 790 method.   Stephen Langille, senior microbiology consultant with ValSource, Inc, and a former microbiologist with the ag...
  • Regulatory NewsRegulatory News

    FDA calls on firms to be ‘recall ready’ in final guidance

    The US Food and Drug Administration (FDA) on Thursday finalized guidance to help regulated industry initiate prompt recalls of violative products. The guidance covers voluntary recalls of drugs, devices, biological products, food, cosmetics and tobacco.   The document addresses how firms should devise a recall communication plan and train personnel on executing a recall, as well as how companies should maintain distribution records and establish procedures for initia...
  • Regulatory NewsRegulatory News

    FDA finalizes guidance on pre-launch drug import policy

    The US Food and Drug Administration (FDA) on Wednesday finalized guidance to assist sponsors in submitting requests to import unapproved finished drugs prior to market launch of a pending new drug application (NDA), abbreviated new drug application (ANDA) or biologics license applications (BLA).   The guidance outlines the procedures for making these requests under the agency’s Pre-Launch Activities Importation Requests (PLAIR) program and FDA’s timetable for approvi...
  • Regulatory NewsRegulatory News

    Device companies urge FDA to refine guidance on PCLC devices

    Medical devices companies urged the US Food and Drug Administration (FDA) to expand the scope of its recent guidance on assessing physiologic closed-loop control (PCLC) technology to cover non-invasive devices and to incorporate additional standards when outlining patient hazards.   Other companies suggested that FDA include additional examples of sensor performance risks.   The comments were in response to FDA’s draft guidance for manufacturers on developing med...
  • Regulatory NewsRegulatory News

    PFDD: FDA finalizes guidance on identifying what’s important to patients

    The US Food and Drug Administration (FDA) on Friday finalized guidance to assist sponsors collect and submit “important” information from patients and caregivers used for medical product development under the agency’s patient-focused drug development (PFDD) initiative. The final guidance provides greater clarification on how industry can interact early with the agency to obtain feedback on patient experience data.   The guidance contains minor revisions from a draft is...
  • Regulatory NewsRegulatory News

    FDA warns firm for selling unapproved stem cell products and GMP, GTP deviations

    The US Food and Drug Administration (FDA) on 2 February warned an Idaho-based firm, Smart Surgical, dba Burst Biologics, for marketing and distributing allogeneic stem cell products for unapproved uses and for “significant” deviations from current good manufacturing practice (CGMP) and good tissue practice (CGTP) requirements.   The warning letter, which was posted to FDA’s website this week, follows an inspection conducted one year ago, just months before the agency e...
  • RoundupsRoundups

    FDA Approvals Roundup: Pyrukynd and Solosec

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA). New approvals Pyrukynd cleared for hemolytic anemia in adults with rare genetic disorder Agios Pharmaceuticals’ Pyrukynd ( mitapivat; tablets ) has been approved for treating hemolytic anemia in adults with pyruvate kinase (PK) deficiency, a rare genetic disorder that causes the destruction of red blood cells, leading to anemia.   The approval was based ...
  • Regulatory NewsRegulatory News

    FDA’s Califf shares priority list with agency staff

    Combatting misinformation about science and responding to the ongoing COVID-19 pandemic are the top priorities for Robert Califf as he retakes the helm of the US Food and Drug Administration (FDA).   Califf’s priorities were outlined in a 17 February memo to FDA staff, as well as on his new official Twitter feed ( @DrCaliff_FDA ). Califf was as confirmed as commissioner for the second time on 15 February by a narrow win in a 50-46 vote and sworn in two days later. Ca...
  • Regulatory NewsRegulatory News

    Senate confirms Califf as FDA commissioner

    Three months after his nomination by President Joe Biden, and despite weeks of uncertainty over whether he could muster enough Republican votes to overcome Democratic defectors in a narrowly split Senate, Robert Califf was confirmed as commissioner of the US Food and Drug Administration (FDA) for the second time on Tuesday in a 50-46 vote.   The vote came after the confirmation cleared a procedural hurdle on Monday, in which five Republicans joined most Democrats in ...
  • Regulatory NewsRegulatory News

    Industry cites outdated standards as flaw in FDA’s real-world data draft guidance

    The US Food and Drug Administration (FDA) should adopt updated data standards that accommodate the “evolving and emerging” nature of real-world data not currently reflected in the Data Standards Catalogue, according to industry comments on the agency’s draft guidance.   Overall, comments from industry generally supported the principles in FDA’s draft guidance on data standards for drug and biological products submissions containing RWD (RELATED: FDA drafts data sta...
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    FDA issues clinical pharmacology draft guidance for antibody-drug conjugates

    The US Food and Drug Administration (FDA) on Monday issued a draft guidance on clinical pharmacology considerations for sponsors interested in developing antibody-drug conjugates (ADC). There is currently no guidance addressing these drugs, said the agency.   The guidance provides recommendations for ADCs, which are defined as an antibody or antibody fragment conjugated to at least one payload molecule via a chemical linker for treating cancer. They are regulated as ...
  • Regulatory NewsRegulatory News

    FDA issues long-awaited licensing rules for drug distributors and 3PLs

    The US Food and Drug Administration (FDA) on Thursday issued its widely anticipated proposed rule establishing uniform licensing standards for wholesale distributors and third-party-logistics providers (3PLs). The 2013 Drug Supply Chain Security Act (DSCSA) mandated that these rules be in place before these trading partners take possession of prescription drug products.   The agency announced that “the proposed rule, when finalized, would provide greater assuranc...