Issue link: https://www.e-digitaleditions.com/i/1514991
4 Pharmaceutical Technology ® Regulating Innovation, Quality, and Risk eBook January 2024 PharmTech.com Moderating Innovation to Equipoise Risk W hile his focus was on balancing personal freedom versus state power, 18th century political theorist John Locke's following thought could arguably be applied to current pharmaceutical regulators' attitudes when he famously declared, "the end of law is not to abolish or restrain, but to preser ve and enlarge freedom" (1). While those currently reading sundr y obser vations listed on an FDA Form 483 will feel signif icantly "retrained ", the intent of regulations is to allow a fair and equal access to a playing f ield that encourages participation by as many novel and creative solutions, as applied to disease states, as humanly possible. A nshu l Ma nga l, president a nd gener a l cou nsel of Projec t Farma, stated, "The FDA aims to streamline the approval process for platform technologies, leveraging t he Omnibus Appropria- tions Act of 2023 to facilitate referencing prior manufacturing data during t he rev iew process. Encouraging more gene t hera- pies to seek accelerated approval and improving harmonization with global regulators, especially for rare diseases will be of crit- ical importance. Additionally, the FDA is launching the START pilot to support small companies developing gene therapies for rare pediatric diseases, draw ing lessons f rom t he COVID-era Project Warp Speed. If the pilot is successful, it could become a permanent program dedicated to supporting the mission. The agency's continued support will be paramount in propelling the therapeutic pipeline forward and teeing up the sector for another year of groundbreak ing achievements" (2). As i n novat ion accelerates, pha r maceut ica l reg u lators con- t i nue t hei r pat h of ma i nta i n i ng propor t ion, ba la nce, a nd re- straint. Please enjoy the following articles which, in many ways, fully embody that ethos. References 1. Locke, J. Second Treatise of Civil Government 1690. 2. Mangal, A. JP Morgan Healthcare Conference Summary. LinkedIn (accessed Jan. 18, 2023). ■ From the Editor Solutions DRUG P O D C A S T Join the editors as industry experts share insights into your biggest questions Learn about technologies, strategies, and regulations related to the development and manufacture of drug products. To learn more, visit www.pharmtech.com/ drug-solutions-podcast Chris Spivey Editorial Director cspivey@mjhlifesciences.com