Regulatory
🇺🇸 FDA Page 2FDA news and analysis for pharmaceutical BD, investment, and market access · 12 articles on this page
Navigate global pharma regulatory landscapes. Get critical intelligence on FDA, EMA, and global drug approval pathways for strategic decision-making.
Showing 13–24 of 24 articles
FDA Blueprint Aims to Reduce Regulatory Risks for Animal Testing Alternatives
The FDA has released a blueprint to reduce regulatory risks associated with alternatives to animal testing, signaling a significant shift in drug development and regulatory pathways. This initiative aims to streamline the adoption of new approach methodologies (NAMs), potentially accelerating drug approvals and influencing investment strategies.
Impact of CDER Leadership Changes on Pharma Strategy
Recent leadership shifts within the FDA's Center for Drug Evaluation and Research (CDER) signal potential alterations in regulatory priorities and drug approval processes. This analysis explores the strategic implications for pharmaceutical companies, business development teams, and investors.
Real-World Data from EHRs and Claims: Strengths, Limitations, and Regulatory Impact
Real-world data (RWD) from Electronic Health Records (EHRs) and claims offers significant value for pharmaceutical research and regulatory submissions. However, understanding its inherent strengths and limitations is crucial for effective utilization.
EU Publishes Roadmap to Reduce Animal Testing: Implications for Pharma
The European Commission has released a roadmap aimed at phasing out animal testing for chemical safety assessments. This initiative signals a significant shift in regulatory expectations and presents both challenges and opportunities for the pharmaceutical industry.
Navigating FDA's Clinical Trial Transparency Enforcement: A Practical Guide for Sponsors and Sites Post-April 2026
Following FDA's April 2026 reminders, this guide details the critical aspects of clinical trial transparency enforcement for sponsors and research sites. It outlines the regulatory landscape, potential consequences of non-compliance, and actionable strategies to ensure adherence to evolving transparency mandates.
Navigating the Regulatory Landscape: A Strategic Policy Agenda for Private Equity in Healthcare
Private equity's rapid expansion in the healthcare sector has outpaced current regulatory frameworks. This article outlines a strategic policy agenda necessary to safeguard patients, providers, and the integrity of care delivery.
Lilly and Gilead Drive Pharma M&A Surge: A Strategic Market Analysis
Eli Lilly and Gilead Sciences are at the forefront of a significant surge in pharmaceutical M&A activity, signaling a strategic shift towards targeted innovation. This analysis explores the drivers and implications of this trend for industry stakeholders.
Wave Life Sciences' Monthly Dosing Strategy for AATD: A Competitive Analysis
Wave Life Sciences is advancing its RNA editing therapy for Alpha-1 Antitrypsin Deficiency (AATD) with a novel monthly dosing strategy. This approach aims to significantly improve upon current weekly intravenous augmentation therapy, presenting new competitive dynamics and regulatory pathways for AATD treatments.
FDA to Issue Guidance on Animal-Derived Thyroid Products by August 2026, Signaling Regulatory Shift
The U.S. Food and Drug Administration (FDA) has announced plans to issue compliance guidance for animal-derived thyroid products by August 2026. This regulatory development signals a significant shift in the oversight of desiccated thyroid extract (DTE) medications.
DEA Reschedules Marijuana to Schedule III, Expediting Medical Access and Research
The DEA has issued a final order moving FDA-approved marijuana products and state-licensed medical marijuana to Schedule III of the Controlled Substances Act. This expedited action, effective April 22, 2026, significantly alters the federal regulatory landscape for cannabis, aiming to bolster medical research while maintaining strict controls.
FDA Expert Panel to Review Peptide Access, Impacting Compounded Drug Market
The US FDA is convening an expert advisory panel in July 2026 to assess whether certain peptides should be made more widely accessible through licensed compounding pharmacies. This review could significantly impact the availability and regulatory landscape of compounded peptide therapies.
Obefazimod: Abivax Ulcerative Colitis Drug Faces Efficacy vs. Safety Scrutiny
Abivax's obefazimod has demonstrated significant efficacy in ulcerative colitis trials, generating excitement for potential regulatory approval. However, recent reports of cancer cases necessitate a careful evaluation of its safety profile by investors and business development teams.