Regulatory Affairs Professionals Society (RAPS)’s Post

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FDA Seeks Input on its Innovative Manufacturing Technology Strategy The US FDA this week released a draft of its strategic plan to promote the uptake of innovative manufacturing technologies for drugs and biologics. The plan fulfills a mandate of the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals for Fiscal Years 2023-2027 (PDUFA VII) to advance the implementation of innovative manufacturing. It was prompted by the feedback the agency received at its June 8, 2023 public meeting on the use of innovative manufacturing technologies for products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), as well as the barriers impeding their adoption. https://lnkd.in/g4nwXMmD #aspenalert #biotech #bioprocess

#FDA has released its long-awaited draft Platform Technology Designation Program for Drug Development: Guidance for Industry, which could represent a potentially significant shift in the regulatory and commercial strategies for novel drug and biologics products. Our alert looks at the key details. #DrugDevelopment #PlatformTechnology #FDCA

What are some examples of #EMA guidelines and #FDA guidances for Biologics? Please, take a look at the graphic below to find some of them ⬇️ #EMA #FDA #guidances #pharma #OnlineCourses #SymetricTraining

An important ruling from the California Court of Appeal that made waves in the pharmaceutical industry will soon be reviewed by the California Supreme Court. The ruling would open the door for plaintiffs to sue pharmaceutical manufacturers simply for deferring the development of new drugs and threatens to be a tough pill to swallow for manufacturers in all industries. Read Jones Day's Commentary, which analyzes the implications of the ruling. #productliability #pharmaceutical #appellate https://ow.ly/TkPn50RU550

Don't miss out! Register here: https://bit.ly/3Wx3I8q to join us tomorrow, Wednesday, May 22, at 12pm ET for a free webinar, deep-diving the LDT final rule, as well as key takeaways not just for LDT stakeholders, but the potential anticipated impacts on the diagnostics, medical devices, pharmaceutical and biopharmaceutical sectors. #AgencyIQ #Politico #LifeSciences #Regulatory #Regulation #FDA #LDT #Webinar

I am giving a webinar tomorrow on the FDA's LDT final rule! If you're interested in diagnostics policy, the drug development impacts, the future of CDx or what we expect to happen next - or just want to watch me talk at breakneck speed while using more acronyms than we really should in conversation - please join us! Register here -> https://bit.ly/3Wx3I8q

Discover how a deep understanding of process characterization can drive successful clinical phases and accelerate commercial launch of biological drug development. Catalent Biologics experts share their insights here. https://ow.ly/EOEC50RqZIO

Discover how a deep understanding of process characterization can drive successful clinical phases and accelerate commercial launch of biological drug development. Catalent Biologics experts share their insights here. https://ow.ly/EOEC50RqZIO

Drug patents pave the way to profit for pharmaceutical companies. But how exactly do patents make drugs more expensive? Watch the full video in STAT's 'Behind the Counter' series here: https://trib.al/wT2d3a9