Efpia on AI Across the Medicines Lifecycle: Governance, GxP and Regulatory Policy Insights
AI governance across the medicines lifecycle requires attention to five critical stages: planning and design, data collection and processing…
Curated regulatory guidance, clinical analyses, and market reports. AI-summarized, editor-reviewed, instantly downloadable.
Research Pulse
Aggregated from live regulatory feedsNovaPharmaNews hosts 68 curated pharmaceutical whitepapers and industry reports from 8 publishers — FDA and EMA regulatory guidance, clinical analyses, manufacturing intelligence, and market research. 3 featured reports are editor-picked this week. Each landing page includes key takeaways, optional PDF download, and links to related drugs, companies, and pipeline data.
Methodology & data sources Publications & analysis Editorial policy
Efpia on AI Across the Medicines Lifecycle: Governance, GxP and Regulatory Policy Insights
AI governance across the medicines lifecycle requires attention to five critical stages: planning and design, data collection and processing…
ICH Technology Platform Report: Secure Collaboration Requirements for Regulatory Harmonisation
A single cloud-based platform hosted in Switzerland would enable secure, temporary sharing of commercially confidential information between …
Digital Money report summary: monetary architecture, CBDC, stablecoins and regulation
Digital money is fundamentally an institutional and policy issue, not merely a technical one. The critical questions concern who creates mon…
Institutional Recognition of SoTL in Health Professions Education: Scoping Review for Education
SoTL is described with shared core concepts across health professions education literature, but operationalized in varied ways that often bl…
WHO Revised Biosimilar Guidelines: Streamlined Regulation for Improved Global Access
WHO's 2022 revised guidelines eliminate the need for mandatory clinical efficacy studies for biosimilars when strong analytical and pharmaco…
Precision Prevention: UK Government's Role in Unlocking Biology-Based Cancer Prevention Research
Currently, 40% of cancers are preventable via known risk factors; precision prevention could increase this proportion by targeting the biolo…
Japan and China Drug IP: Data Exclusivity and PTE
China's NMPA issued Implementation Measures for Drug Trial Data Protection, introducing up to 6-year data exclusivity for innovative drugs.
ICAOS Bench Book: Interstate Offender Supervision Guide
The ICAOS, effective since 2002, replaced the 1937 Interstate Compact for Probation and Parole (ICPP) and serves as binding federal law gove…
Mitigating Prior Authorization Burdens: Insights from Reference Committee G
Ninety-three percent of physicians report delays in patient care due to prior authorization.
Digital Transformation in Pharma CRM: Enhancing HCP Engagement
Digital channels are increasingly preferred by HCPs over traditional in-person interactions.
RYBREVANT® Access and Reimbursement Guide Overview
RYBREVANT® is indicated for specific NSCLC mutations, including EGFR exon 19 deletions, exon 21 L858R substitution mutations, and exon 20 in…
Guidance on Developing Treatments for Stimulant Use Disorders
FDA has not yet approved any medications for stimulant use disorders.
Comparative Analysis of FDA and EMA Drug Approval Processes
The FDA employs a centralized and flexible approval system with expedited pathways, potentially leading to shorter review timelines.
GxP Environmental Monitoring Systems: A Guide for Small Biotechs
Essential guide for small biotechs on GxP environmental monitoring systems to ensure compliance and product quality.
FDA's April 30, 2026 ODAC Meeting on Camizestrant Review
Camizestrant is under review for the treatment of ESR1m/HR+/HER2- advanced breast cancer (ABC).
Data First: Enhancing Drug Development with FAIR-by-Design Standards
FAIR-by-design standardization is a necessary investment for maximizing NAM data utility.
Did You Know: Insights from NCPDP's Active Task Groups
NCPDP has 71 active task groups focusing on diverse areas of pharmacy standards.
A26 Informational Reports: Insights for Pharma Stakeholders
Total grants and donations received by the AMA in 2025 amounted to $3,666,000, supporting various public health initiatives.
Entity directories linked from research reports and market briefs.
Our research library curates FDA, EMA, and industry publisher PDFs — regulatory guidance, clinical analyses, manufacturing reports, and market intelligence. Each report includes an AI-summarized landing page with key takeaways and a gated PDF download.
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Report pages link to related intelligence — company profiles, drug INN pages, clinical trials, pipeline programs, and topic hubs. Use the intelligence spokes on each page to explore the entity graph behind the research.
New reports are ingested daily from leading publishers and regulatory sources. Featured picks highlight high-impact FDA, EMA, and industry research each week.