• Regulatory NewsRegulatory News

    Unannounced FDA inspections in India, China to begin soon

    An official with the US Food and Drug Administration (FDA) announced the agency will soon resume unannounced onsite inspections in India and China. Also, prioritized foreign inspections will resume in February.   Elizabeth Miller, assistant commissioner for medical products and tobacco operations in FDA’s Office of Regulatory Affairs (ORA), provided this update on the agency’s inspection activities at a 9 December virtual conference on enforcement sponsored by the Fo...
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    FDA Approvals Roundup: Entadfi, Zynrelef, Rinvoq

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Entadfi okayed for benign prostatic hyperplasia Veru’s Entadfi (finasteride and tadalafil capsules) has been approved for treating urinary tract symptoms caused by benign prostatic hyperplasia (BPH), or enlarged prostate. The combination has also been shown to have less potential for adverse sexual side effects compared with finasteride mono...
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    FDA releases draft guidances on developing rhinosinusitis drugs, colonoscopy bowel preps

    The US Food and Drug Administration (FDA) has recently released two draft guidances: one with advice for sponsors on the development of drugs for the treatment of chronic rhinosinusitis with nasal polyps (CRSwNP), and another offering efficacy and safety considerations for the development of bowel cleansing products for colonoscopy.     Guidance on CRSwNP drugs   The agency provided recommendations for sponsors involved in a CRSwNP drug’s development, including d...
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    Califf skates through nomination hearing

    Despite some rumbling about his ties to the pharmaceutical and tech industries, Robert Califf breezed through a two-hour nomination hearing on Tuesday for a second stint as commissioner of the US Food and Drug Administration (FDA).   Califf’s nomination by President Joe Biden last month came after a protracted period of speculation as to who would be chosen to lead FDA at an unprecedented time in the agency’s history. During the hearing, Califf laid out three overarchi...
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    Recon: Califf's Senate hearing; Moderna, Amgen pull out of JPM

      Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Former FDA commissioners endorse Califf as head of agency, citing urgency of addressing omicron ( WaPo ) Califf goes to Congress ( POLITICO ) Moderna, Amgen among biotech heavyweights pulling out of JPM conference over Covid concerns ( STAT ) US FDA’s Woodcock Sees Clinical Trial Reform Coming, But ‘Not Wholly Optimistic’ ( Pink Sheet ) Pfizer says its Co...
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    FDA issues final guidance on pediatric anti-infective development

    The US Food and Drug Administration (FDA) on Thursday issued a final guidance to assist sponsors in developing anti-infective drugs for the pediatric population. The guidance revises the draft version by providing more information on safety data collection and juvenile toxicity studies.   The guidance provides recommendations for developing anti-infective drugs, including antibacterials, antifungals, and antiparasitic products, for pediatric populations. A dra...
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    This Week at FDA: Bardoxalone strikes out at adcomm; Updated device consensus standards

    Happy Friday – this week we’re juggling lots of end-of-year activity from the US Food and Drug Administration (FDA). Today and in the next week, look for our contributors to highlight several draft and final guidance documents and to provide analysis and background on industry’s reactions to other guidances whose comment periods have recently closed.   The Center for Drug Evaluation and Research (CDER) released its fall/winter 2021 regulatory science news update today....
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    Pharma, device groups oppose FDA's planned drug to device transition

    Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to devices, in implementing a recent court decision. The Association for Accessible Medicines (AAM) says that the agency’s implementation of the order is hasty and has no legal merit, while the Advanced Medical Technology Association (ADVAMED) pointed out that compani...
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    Gene therapy developers can expect less hand-holding from OTAT

    A growing workload and insufficient staffing have prompted the US Food and Drug Administration’s (FDA) Office of Tissues and Advanced Therapies (OTAT) to institute new processes to expedite its reviews of new cell and gene therapies, said OTAT Director Wilson Bryan at a 6 December webinar sponsored by the Alliance for a Stronger FDA.   At the webinar, Bryan was asked to discuss the impact of the projected workload for OTAT, projections for approving new cell and gene t...
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    FDA issues final guidance on CMC postapproval changes for annual reports

    The US Food and Drug Administration (FDA) on Thursday issued a final guidance to help manufacturers of certain biological products determine which types of changes to their products should be submitted in annual reports for changes expected to have a minimal impact on product quality. The final guidance differs from the draft in providing more examples of changes that can be submitted in annual reports; however, FDA rejected calls from industry to provide a timeframe for...
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    FDA issues draft guidance on study designs using real-world data

    The US Food and Drug Administration (FDA) has issued draft guidance to industry on how real-world data (RWD) could be used in clinical trials and how it could be incorporated into the design of non-interventional studies.   The draft guidance , released Thursday, outlines the applicability of FDA’s investigational new drug application (IND) regulations to clinical study designs that use RWD and clarifies the agency’s expectations on new drug applications (NDAs) or bio...
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    FDA Approvals Roundup: Xaciato, cutaquig, Rituxan

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Xaciato okayed for treating bacterial vaginosis Daré’s Xaciato (clindamycin phosphate vaginal gel ) has been approved to treat bacterial vaginosis in patients aged 12 years or older.   The approval was based on findings from the Phase 3 multicenter, double-blind, placebo-controlled DARE-BVFREE study in which 307 patients from the indicate...