FDA’s Post

Ready to become an expert in #druginformation? Drug and Chemical Information 3. Exploring New Drug Research is intended to introduce librarians to the NLM resources that provide drug and chemical information for healthcare professionals and researchers conducting systematic reviews or other in-depth research. You will learn to locate clinical trials in PubMed and ClinicalTrials.gov about a specific drug therapy. Free Registration: https://lnkd.in/gQrEc87v #medlibs #drugresearch #systematicreview #clinicaltrials

The transformation of the regulatory framework for eCTD submissions in China goes beyond a mere change in how submissions are made. It symbolizes China's dedication to embracing digital transformation, nurturing innovation, and guaranteeing the prompt accessibility of safe and efficacious medications for its population. To know about eCTD submissions in China, gain access to the latest webinar recording https://lnkd.in/g6CVwPW4 #pharmaceuticals #eCTD #China

The transformation of the regulatory framework for eCTD submissions in China goes beyond a mere change in how submissions are made. It symbolizes China's dedication to embracing digital transformation, nurturing innovation, and guaranteeing the prompt accessibility of safe and efficacious medications for its population. To know about eCTD submissions in China, gain access to the latest webinar recording https://lnkd.in/g6CVwPW4 #Pharmaceuticals #eCTDsubmissions #China #FreyrSolutions

Learn best practices for planning an externally controlled trial

Analytical methods now provide greater assurance of biosimilarity, questioning the need for comparative clinical trials. Cecil Nick, VP Technical – Parexel Regulatory Strategy, shares highlights from the recent FDA and IPRA scientific workshop on biosimilar development workshop and discusses the challenges and limitations of comparative efficacy trials in biosimilar development programs. The workshop showcased perspectives from regulatory agencies including FDA, EMA, UK MHRA, WHO, and experts from industry, all expressing openness to reconsidering current requirements for comparative efficacy studies. The shift towards a more streamlined, quality-based approach to biosimilar approvals holds the promise of increasing affordability and access to innovative therapies for patients. Read the blog post to stay updated on the latest in biosimilar development and how Parexel continues to pioneer in this field. #biosimilars #clinicaltrials #biotech #innovation

Analytical methods now provide greater assurance of biosimilarity, questioning the need for comparative clinical trials. Cecil Nick, VP Technical – Parexel Regulatory Strategy, shares highlights from the recent FDA and IPRA scientific workshop on biosimilar development workshop and discusses the challenges and limitations of comparative efficacy trials in biosimilar development programs. The workshop showcased perspectives from regulatory agencies including FDA, EMA, UK MHRA, WHO, and experts from industry, all expressing openness to reconsidering current requirements for comparative efficacy studies. The shift towards a more streamlined, quality-based approach to biosimilar approvals holds the promise of increasing affordability and access to innovative therapies for patients. Read the blog post to stay updated on the latest in biosimilar development and how Parexel continues to pioneer in this field. #biosimilars #clinicaltrials #biotech #innovation

Analytical methods now provide greater assurance of biosimilarity, questioning the need for comparative clinical trials. Cecil Nick, VP Technical – Parexel Regulatory Strategy, shares highlights from the recent FDA and IPRA scientific workshop on biosimilar development workshop and discusses the challenges and limitations of comparative efficacy trials in biosimilar development programs. The workshop showcased perspectives from regulatory agencies including FDA, EMA, UK MHRA, WHO, and experts from industry, all expressing openness to reconsidering current requirements for comparative efficacy studies. The shift towards a more streamlined, quality-based approach to biosimilar approvals holds the promise of increasing affordability and access to innovative therapies for patients. Read the blog post to stay updated on the latest in biosimilar development and how Parexel continues to pioneer in this field. #biosimilars #clinicaltrials #biotech #innovation

Analytical methods now provide greater assurance of biosimilarity, questioning the need for comparative clinical trials. Cecil Nick, VP Technical – Parexel Regulatory Strategy, shares highlights from the recent FDA and IPRA scientific workshop on biosimilar development workshop and discusses the challenges and limitations of comparative efficacy trials in biosimilar development programs. The workshop showcased perspectives from regulatory agencies including FDA, EMA, UK MHRA, WHO, and experts from industry, all expressing openness to reconsidering current requirements for comparative efficacy studies. The shift towards a more streamlined, quality-based approach to biosimilar approvals holds the promise of increasing affordability and access to innovative therapies for patients. Read the blog post to stay updated on the latest in biosimilar development and how Parexel continues to pioneer in this field. #biosimilars #clinicaltrials #biotech #innovation

Analytical methods now provide greater assurance of biosimilarity, questioning the need for comparative clinical trials. Cecil Nick, VP Technical – Parexel Regulatory Strategy, shares highlights from the recent FDA and IPRA scientific workshop on biosimilar development workshop and discusses the challenges and limitations of comparative efficacy trials in biosimilar development programs. The workshop showcased perspectives from regulatory agencies including FDA, EMA, UK MHRA, WHO, and experts from industry, all expressing openness to reconsidering current requirements for comparative efficacy studies. The shift towards a more streamlined, quality-based approach to biosimilar approvals holds the promise of increasing affordability and access to innovative therapies for patients. Read the blog post to stay updated on the latest in biosimilar development and how Parexel continues to pioneer in this field. #biosimilars #clinicaltrials #biotech #innovation

Analytical methods now provide greater assurance of biosimilarity, questioning the need for comparative clinical trials. Cecil Nick, VP Technical – Parexel Regulatory Strategy, shares highlights from the recent FDA and IPRA scientific workshop on biosimilar development workshop and discusses the challenges and limitations of comparative efficacy trials in biosimilar development programs. The workshop showcased perspectives from regulatory agencies including FDA, EMA, UK MHRA, WHO, and experts from industry, all expressing openness to reconsidering current requirements for comparative efficacy studies. The shift towards a more streamlined, quality-based approach to biosimilar approvals holds the promise of increasing affordability and access to innovative therapies for patients. Read the blog post to stay updated on the latest in biosimilar development and how Parexel continues to pioneer in this field. #biosimilars #clinicaltrials #biotech #innovation