• Regulatory NewsRegulatory News

    FDA blasts US API firm for lax response to mold contamination, data integrity failings

    A US manufacturer of active pharmaceutical ingredients (API) was lambasted in a recent warning letter by the US Food and Drug Administration (FDA) for multiple good manufacturing practice (GMP) violations, one of which was a failure to adequately respond to mold contamination.   The firm also failed to maintain control over its computer systems to prevent unauthorized access to electronic data.   The warning letter was issued on 18 July to St. Louis-based manufactu...
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    FDA finalizes guidance on including patients with incurable cancers in oncology trials

    The US Food and Drug Administration (FDA) has issued final guidance on the inclusion of patients with incurable cancers in clinical trials for investigational therapies.   In their guidance, the agency recommended sponsors include patients with incurable cancer—defined as unresectable, locally advanced, or metastatic disease in solid tumors and/or hematologic malignancies with unfavorable long-term overall survival—in oncology clinical trials even if they met criteria ...
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    FDA proposes checklist to inform patients of LASIK surgery risks

    The US Food and Drug Administration (FDA) on Wednesday released draft guidance on conveying the potential risks with Laser-Assisted In Situ Keratomileusis (LASIK) laser products in labeling to better convey these risks to consumers.   On 27 July, FDA published a draft guidance titled Laser-Assisted In Situ Keratomileusis (LASIK) Lasers–Patient Labeling Recommendations . As more potential side-effects of LASIK treatments have become known over the years, the agency hop...
  • ReconRecon

    Recon: Senate Democrats agree on $430 billion reconciliation bill with drug pricing measures; Cassava faces criminal probe over falsified data for Alzheimer's drug

    Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.   In Focus: US Democrats Manchin, Schumer agree on $430 billion tax, drugs, energy bill ( Reuters ) ( Endpoints ) ( Inside Health Policy ) ( Politico ) Two sides of 'historic' drug pricing bill: Pharma industry blasts 'mistake' while advocates plan for 'first ever' gains ( Endpoints ) Merck CEO concerned about proposed drug pricing bill hurting innovation ( Reuters ) GSK’s B...
  • Feature ArticlesFeature Articles

    Personalized nutrition

    Personalized nutrition is founded in evidence-based science and draws on individual-specific information to help consumers promote positive, sustainable dietary behavioral change resulting in measurable benefits in health improvement and maintenance, or disease-specific benefits. This article provides a comprehensive definition of personalized nutrition and examines its regulation globally and in the EU in regard to data protection, product qualification, and claims.   ...
  • RoundupsRoundups

    Euro Roundup: EMA recommends monkeypox vaccine as multifront response advances

    The European Medicines Agency (EMA) has recommended the approval of Bavarian Nordic’s Imvanex for the prevention of monkeypox disease. EMA’s backing of the vaccine is part of a raft of measures by the agency to tackle the pathogen and mitigate its impact.   Members of EMA’s Committee for Medicinal Products for Human Use recommended the approval of the vaccine late last week. Bavarian Nordic won approval for the product for the prevention of smallpox in the European Uni...
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    EMA to address nitrosamine impurities in upcoming revision of active substances guidance

    The European Medicines Agency (EMA) will be updating its guideline on active substances to incorporate strategies for controlling and preventing nitrosamines in drug products and active pharmaceutical ingredients (APIs), the agency announced in a new concept paper .   The revised guideline is meant to address risk factors for formation of nitrosamines in medicinal products and strategies for preventing their formation and presence.   EMA and other regulators have ...
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    FDA finalizes ANDA CRL, Orange Book Q&A guidances

    The US Food and Drug Administration has published a final draft guidance that addresses what’s expected when sponsors get complete response letters (CRL) to their abbreviated new drug applications (ANDAs). The agency also finalized another guidance explaining its responsibilities for maintaining and updating the Orange Book , which contains lists patent and exclusivity information for drugs with therapeutic equivalence evaluations.   On 22 July, FDA published two fina...
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    Neonatal drug development addressed in FDA final guidance

    The US Food and Drug Administration (FDA) issued final guidance this week to assist sponsors in developing clinical pharmacology studies for neonatal populations. The guidance is meant to address gaps in neonatal labeling and encourage the development of therapies that are “unique to neonates.”   The guidance is tailored to sponsors developing these studies for investigational new drug applications (INDs), new drug applications (NDAs), biologics license applications ...
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    The impact of Brexit on food supplements and specialized food products

    This article examines the impact of diverging regulations and practices for food supplements and specialized food products since the UK left the EU market in 2020.   Keywords – Brexit, divergence, food supplements, UK, Northern Ireland   Background and introduction On 23 June 2016, the UK, comprising England, Northern Ireland, Scotland, and Wales, held a referendum on whether the UK should remain in the EU or leave. Based on an overall majority of 51.9% on ...
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    FDA announces plans to revamp national drug code

    The US Food and Drug Administration (FDA) on Monday proposed an update to the National Drug Code (NDC), replacing the existing 10-digit format with a 12-digit format in anticipation of a looming exhaustion of these codes within the next ten to 15 years.   The rule would retain the three-segment code consisting of the labeler code, the product code and the packaging code. The NDC is used to register and track pharmaceutical products through the supply chain.   Under...
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    FDA explains the ins and outs of real-time oncology review program in new guidance

    Cancer drugs under development that show substantial promise over existing therapies and have simple study designs, as well as easy to interpret endpoints, may qualify for a head-start review from the US Food and Drug Administration (FDA). While the drug will ultimately be reviewed under the same user fee time frame as other products, it may help speed up the review process for sponsors.   On 22 July, FDA published a draft guidance titled, Real-Time Oncology Review (...