• Regulatory NewsRegulatory News

    Combination products: FDA finalizes list of CGMP alternatives, streamlined mechanisms

    The US Food and Drug Administration (FDA) has released a finalized list of alternatives and streamlined mechanisms for current good manufacturing practice (CGMP) of combination products.   Initially, FDA released a proposed list of alternative or streamlined mechanisms for compliance with CGMP for combination products in June 2018. This proposed list was intended to meet the requirements of the 21st Century Cures Act , which directed FDA to post such a list to the ...
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    Asia-Pacific Roundup: Indian Pharmacopoeia joins global discussion group pilot

    The international Pharmacopoeial Discussion Group (PDG) has accepted the Indian commission into a one-year pilot that is intended to expand its membership beyond the European Union, Japan and the US.   Almost one year ago, PDG revealed it was preparing a pilot to integrate additional world pharmacopeias. PDG is currently made up of the European Pharmacopoeia, the Japanese Pharmacopoeia and the United States Pharmacopeia, with the World Health Organization acting as an ...
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    Recon: Akero drug meets goal in NASH study; Novartis to invest $300M in biologics operations

    Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.   In Focus: US Deal or no deal: User fee reauthorization edition ( Politico ) Sony announces development of its first over-the-counter hearing aid for the US ( The Verge ) Moonshot refresh: Biden calls to cut cancer death rate by at least 50% in 25 years ( Endpoints ) Biden looks to beef up US biomanufacturing amid pressure from China ( Fierce ) Exclusive: Medical journals broad...
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    Nearly one in five regulatory professionals changed jobs in 2021, new report shows

    Pay raises, job changes, and new work environments are among the top findings from the RAPS 2022 Global Compensation and Scope of Practice Report for the Regulatory Profession , the largest and most comprehensive research initiative on the global regulatory profession. The report gives regulatory professionals and their employers a one-of-a-kind look at the profession with data on compensation, job responsibilities, career experience, education and more. The report ...
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    FDA finalizes guidance on submitting RWD/RWE in application cover letters

    To help better track submissions that include real-world data (RWD) and real-world evidence (RWE), the US Food and Drug Administration (FDA) is asking drug and biologics sponsors to indicate the inclusion of such data in their premarket application cover letters.   On 8 September, FDA published a final guidance titled, Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products . The draft version of the guidance was publ...
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    FDA issues guidance documents on labeling drug identity, constituents

    The US Food and Drug Administration (FDA) has issued two draft guidance documents aimed at improving the consistency of labeling for both over-the-counter (OTC) and prescription drugs. One of the guidance document addresses the statement of identity and drug strength for OTC products and the other relates to the quantification of sodium, potassium and phosphorus and prescription and OTC drugs.   Identify and strength labeling   In draft guidance issued on 8 Septe...
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    ARTICLE OF THE YEAR: The linguistic review process in the centralized procedure in the EU

    In the EU and European Economic Area (EEA), certain products receive marketing authorization through the centralized procedure (CP). Following this, a number of documents, such as the product information (PI), require translation into all 24 EU and EEA official languages. The translations provided by the marketing authorisation holder (MAH) are approved by the corresponding EU member states. This review and approval process of the 24 languages is known as the linguistic re...
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    FINALIST Fostering diversity and talent: A Pfizer case study

    The Pfizer Global Regulatory Affairs (GRA) – Howard University College of Pharmacy (HUCOP) Advanced Pharmacy Practice Experience (APPE) program fulfills a requirement of the Doctor of Pharmacy (PharmD) curriculum and helps students explore biopharmaceutical industry career options and prepare for their career after graduation, such as pursuing postgraduate training and seeking employment. The HUCOP Preceptorship Program at Pfizer was designed to broadly increase awareness ...
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    FINALIST New method to an old approach: A semiquantitative approach for determining probability of regulatory success for ASEAN markets

    An objective assessment guide for estimating the likelihood of obtaining regulatory approval for marketing authorization applications submitted to local regulatory agencies is critical to facilitate commercial launch planning. In this paper, we describe a harmonized guide designed to estimate the probability of regulatory success (PRS) in the Association of Southeast Asian Nations (ASEAN). This guide focuses on a standardized set of criteria for semiquantitative assessment...
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    FINALIST Patient-reported outcomes and patient preference information in regulatory decision making

    This article discusses the patient-focused trends in collecting patient experience data (PED), such as patient-reported outcomes (PROs) and patient preference information (PPI), for use in regulatory decision making and drug development. The authors cover current programs initiated by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) and discuss how the agencies and sponsors can collaborate to elevate the role of PROs and PPI in informing regula...
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    FINALIST Maximizing the potential of the FDA assessment aid: Genentech’s experience

    The assessment aid (AAid), an initiative of the US Food and Drug Administration’s (FDA’s) Oncology Center of Excellence (OCE), was introduced in 2018 as a pilot program to help streamline the agency’s review of oncology drug applications. In this article, Genentech shares its experience with the AAid to date and provides recommendations for preparing the AAid and improving the process to fully realize its benefits. Keywords – assessment aid, FDA OCE pilots, oncology dr...
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    Convergence: Experts see hope for meeting EU MDR deadlines

    PHOENIX, AZ – With the European Union’s Medical Device Regulation (MDR) grace period ending in 2024, many medical device companies and consultants are nervous about what that means for their products, especially with limited notified body capacity. While some have fretted about getting new certificates of conformity under MDR in time for the 2024 deadline, experts on a panel on the topic at RAPS Convergence 2022 said there is light at the end of the tunnel.   During ...