• Regulatory NewsRegulatory News

    Shuren: Let’s take regulatory flexibility beyond COVID-19

    Congressionally authorized regulatory flexibility could provide medical device manufacturers with more options and help the US Food and Drug Administration (FDA) better monitor product safety and efficacy, according to Jeff Shuren, director of the FDA Center for Devices and Radiological Health (CDRH).   “There really is a need for more flexibility to have agile regulation,” said Shuren during a fireside chat on 22 March at the Duke-Margolis Center for Health Policy’s d...
  • Regulatory NewsRegulatory News

    FDA, EMA tout benefits of parallel scientific advice program

    Regulators described how the parallel scientific advice (PSA) program offered by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) saves sponsors time and resources by bringing both health authorities to the table to hammer out solutions to complex scientific issues arising from their drug development packages at a 16 March webinar held by FDA’s Small Business and Industry Assistance (SBIA) program.   The goal of the PSA program is to ...
  • RoundupsRoundups

    FDA Approvals Roundup: Adlarity and Lynparza

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Adlarity transdermal patch okayed for dementia in patients with Alzheimer’s disease Corium’s Adlarity ( donepezil; transdermal system ) has been approved for mild, moderate, or severe dementia in patients with Alzheimer's disease. The drug was approved via the 505(b)(2) pathway that allows drugs to be approved based in part on data from stud...
  • Regulatory NewsRegulatory News

    FDA resuming normalized operations but will continue to leverage MRAs

    As the US Food and Drug Administration (FDA) returns to normalized operations with onsite inspections, it will continue to take a risk-based approach in determining which firms are inspected next and continue to rely on mutual recognition agreements (MRAs) with other countries in assessing pharmaceutical facilities, according to Alonza Cruse, director of FDA’s pharmaceutical quality operations.   Cruse discussed how the agency is transitioning to normal operations on 1...
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    Quality metrics: FDA wants feedback on pared-down program

    The US Food and Drug Administration (FDA) on Wednesday outlined a pared-down plan to collect quality metrics data from drugmakers in an attempt to renew its earlier stalled effort to obtain manufacturing quality data as a means of mitigating potential drug shortages and promoting enhanced quality management in the pharmaceutical industry.   The agency stressed in an announcement that this program would be different from the original quality metrics draft guidance unv...
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    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...
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    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...
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    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...
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    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...
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    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...
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    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 ...