Results 11 to 20 of about 7,323,481 (90)
The FDA Food Safety and Modernization Act and the Exemption for Small Firms [PDF]
, 2017 The FDA Food Safety Modernization Act of 2010 is new legislation that mandates, among other things, new food safety standards. The act includes a clause that exempts small firms from new regulatory requirements.
Pouliot, Sebastien
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United States Food Law Update: The FDA Food Safety Modernization Act, Obesity and Deceptive Labeling Enforcement [PDF]
, 2011 The long-awaited enactment of the FDA Food Safety Modernization Act (FSMA), the most significant amendment to the Federal Food, Drug, and Cosmetic Act in several decades, provides the Food and Drug Administration (FDA) with significantly enhanced ...
Johnson, Nicholas R., Endres, A. Bryan
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Il Food Safety Modernization Act
, 2016 The matter of food security has a complex nature and is governed by regulations that seek to take into account and balance a varied set of social and economic interests. Since 2011, following the enactment of the Food Safety Modernization Act (FSMA), the
Roberto De Giorgio, De Giorgio, Roberto
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Advanced Science, EarlyView.A microfluidic tumor platform integrates pharmacokinetic flow control, vascular‐like barriers, and 3D tumor spheroids to emulate in vivo drug exposure. The system reproduces dynamic concentration–time profiles and enables size‐dependent nanoparticle transport and efficacy evaluation, providing a predictive framework for assessing nanomedicine ...
Su Jeong Kang +5 more
wiley +1 more source
Value of Information of Improved Traceability in Fresh Produce Markets
Agribusiness, EarlyView.ABSTRACT Traceability plays an important role in promoting a safe food supply by fostering transparent information exchange along the food supply chain. New technological innovations have the potential to improve traceability outcomes, as greater transparency along the food supply chain can aid in pinpointing precise origins of the contamination ...
Kelsey Vourazeris +2 more
wiley +1 more source
British Journal of Clinical Pharmacology, EarlyView.Abstract Despite regulatory progress being made in the past two decades, off‐label drug use in paediatrics remains pervasive, with prevalence estimated between 3% and 97% of prescriptions across different clinical settings. Off‐label use—defined as prescribing outside the conditions described in the Summary of Product Characteristics (SmPC)—is often ...
Tjitske M. van der Zanden +3 more
wiley +1 more source
Regulatory harmonization: Evolution, globalization and future directions
British Journal of Clinical Pharmacology, EarlyView.Regulatory harmonization has become an increasingly important and accepted approach to streamline regulatory review processes and expedite access to safe, effective and high‐quality medicines globally. This review explores the evolution and current status of regulatory harmonization, convergence and reliance initiatives.
Orin Chisholm +2 more
wiley +1 more source
Biotechnology and Bioengineering, EarlyView.Lifecycle perspective on cell and gene therapy manufacturing challenges and enabling GMP solutions. ABSTRACT Cell and gene therapies (CGTs) are revolutionizing modern medicine; however, making these advanced medicines scalable and readily available to commercial manufacturers worldwide is a major challenge. The number of approved CGT products continues
Rajath Samaga +2 more
wiley +1 more source
Implementation of the FDA Food Safety Modernization Act (FSMA, P.L. 111-353) [PDF]
, 2014 This report documents the scheduled timeline for action on selected FDA Food Safety Modernization Act (FSMA) provisions, as specified in the enacted law, and FDA-reported actions taken to date, based on available FDA press releases and publicly available
Johnson, Renée
core
Digital Transformation of Medicines Regulation in Africa—Perspectives from a Stakeholder Convening
Clinical Pharmacology &Therapeutics, EarlyView.Regulatory authorities worldwide are developing strategies to integrate artificial intelligence (AI) into the lifecycle of health products, technologies, and medicines. While regulators share goals of improving efficiency, strengthening decision‐making, and protecting public health, their approaches differ according to institutional structures ...
Christelna Reyneke +12 more
wiley +1 more source