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    Update on FDA regulation of ophthalmic combination products

    Ophthalmic products are regulated under quality standards published in the Code of Federal Regulations (CFR), United States Pharmacopeia (USP), and various US Food and Drug Administration (FDA) guidance. Application of these standards has recently been affected by the legal requirement for the FDA to standardize the regulatory approach to ophthalmic products whose components are considered devices. The agency communicated the update through a guidance outlining the phase-i...
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    Regulatory ad promo in a co-promotion setting

    Co-promotion agreements between two pharmaceutical companies amplify marketing efforts for a product and boost market penetration. It entails collaboration between the companies during the review and approval of the promotional and nonpromotional product information materials. This article will focus on co-promotion in the regulatory advertising and promotion (ad promo) setting. It includes basic principles and best practices in implementing the promotional review process ...
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    Budget law calls for BARDA and FDA to establish “warm base” manufacturing to better prepare for future pandemics

    The federal budget law passed by Congress and signed by the president in late December calls on federal authorities to establish “warm base” domestic manufacturing to respond quickly to demand surges for medical products during a public health emergency.   Section 2401 of the law calls on the Biomedical Advanced Research and Development Authority (BARDA) to work with the US Food and Drug Administration (FDA) to coordinate these efforts.   The law amends Section 319...
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    Omnibus brings new advanced manufacturing programs to FDA

    The recently enacted ominous spending bill approved by Congress in late December directs the US Food and Drug Administration (FDA) to establish advanced manufacturing centers for excellence and an advanced manufacturing technologies designation program.   The omnibus spending bill was signed by President Biden on 27 December and authorizes $3.5 billion in budget authority for the US Food and Drug Administration (FDA) in FY 2023, a 6.5% increase compared to its 2022 bud...
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    ICH touts adoption of continuous manufacturing, safety reporting guidelines

    The International Council for Harmonisation (ICH) announced that “excellent progress” has been made over the past year in advancing guidelines in the areas of pharmaceutical quality, safety and efficacy, including the adoption of the widely awaited guideline on continuous manufacturing (CM).   These achievements were announced on 22 November following its meeting held in Inchon, South Korea. The meeting was held in parallel with meetings of ICH’s ten working groups and...
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    Foods for special medical purposes/medical foods: A global regulatory synopsis

    This two-part article covers the specific requirements for placing foods for special medical purposes (FSMPs) on the market in major jurisdictions – EU, UK, US, China, and other regions of the world – to improve the role of nutrition in support of optimal care for patients. Part 1 covers general principles governing FSMPs, use of FSMPs in community and hospital settings, common regulatory challenges, opportunities for category growth, and considers a multistakeholder initi...
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    FDA official offers insights on Emerging Technology Program

    The US Food and Drug Administration (FDA) accepts a wide variety of applications into its Emerging Technologies Program (ETP), and is not just focused on continuous manufacturing, said Joel Welch, associate director for science and biosimilar strategy in the agency’s Office of Biotechnology Products.   “I think that sometimes there is a misperception that advanced manufacturing is just about continuous manufacturing,” said Welch who provided an update on the ETP at the...
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    EU issues long-awaited GMP Annex 1 revision

    The EU’s eagerly anticipated revision of its good manufacturing practice (GMP) Annex 1 for sterile drug products was released on Thursday after 14 years of development. The revised requirements, which are set to take effect 25 August 2023, govern the manufacturing of sterile drugs made in the EU, as well as imported products.   The revised Annex comes after hints earlier this year that it be out in mid-2022. (RELATED: EU GMP Annex 1 revision to be released mid-year ...
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    Continuous manufacturing applicants saw quicker approvals, higher revenue than batch applicants

    Applicants that used continuous manufacturing (CM) technology to bring their products to market waited less time before approval after submission compared to batch manufacturing products, according to results from a US Food and Drug Administration (FDA) audit published in the International Journal of Pharmaceuticals .   Authors from the FDA Center for Drug Evaluation and Research (CDER) said these manufacturers had a potential estimated increase in revenue due to the ...
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    Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

    Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to...
  • RF Quarterly

    Evolution of the Japanese regulatory system and agencies

    The Japanese regulatory system has been recognized as one of the most sophisticated and stringent regulatory systems in the world. The regulatory policies are developed and administered by the Ministry of Health, Labour and Welfare (MHLW), the Pharmaceuticals and Medical Devices Agency (PMDA) executes the policies, and certain authorities are delegated to local governments. Over the last 6 decades, the Japanese regulator has faced many challenges but has kept enhancing the...
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    Medtech Industry: FDA emergency product shortage reporting guidance is too broad, burdensome

    Draft guidance from the US Food and Drug Administration on reporting medical device and diagnostic shortages for public health emergencies is too broad and potentially could be too resource intensive for manufacturers as well as regulators, representatives from medtech industry groups believe.   In January, the FDA published a draft guidance that outlines when and how the agency wants medtech manufacturers to alert the agency of potential product shortages that happen ...