Regulatory Strategy and FDA Policy
The development of drugs, biologics, and medical devices follows rigorous paths to ensure safe and effective medicines. We create FDA regulatory engagement strategies and help clients interpret FDA regulations, guidance, and the likely impact of legislation. Interpreting FDA priorities, resources, User Fee Acts, and label and promotion requirements, our experts can help you manage your pipeline.
FDA Restrictions on PD-L1-Negative Gastric Cancer Treatments
The FDA has limited Keytruda and Opdivo use to PD-L1–positive gastric cancer, raising questions about off-label access and payer coverage.
ACNU Provides a New FDA Approval Pathway for Prescription-to-OTC Drugs
The ACNU final rule provides a new approval pathway for prescription drugs to also gain nonprescription marketing status.
Navigating the Evolving World of Drug Compounding
Drug compounding regulation has evolved due to recent industry trends, emphasizing the need to understand its optimal role in healthcare delivery.
Webinar: Exploring RNA-Based Therapies: Innovations and Impact
Join us for a webinar exploring the RNA-Based Therapy landscape.
The FDA’s Final Rule on Laboratory-Developed Tests (LDTs)
Laura Housman’s article in the July issue of MedTech Intelligence explores the potential impact of the FDA’s rule to overhaul its regulation of LDTs.
Avalere White Paper: RNA-Based Therapy Outlook
A white paper explores the RNA-based therapy pipeline and how FDA classifications can influence product development, commercialization, and patient access.
A Paradigm Shift in LDT Regulation
The FDA’s final rule to regulate LDTs as medical devices brings on numerous uncertainties for stakeholders.
Inequities in Medicare Beneficiaries’ Use of Accelerated Approval Products
An Avalere analysis shows the use of drugs approved under the Accelerated Approval pathway across historically underserved Medicare beneficiaries.
A More Complex Future Market for Diagnostics?
With regulatory changes on the horizon, diagnostics stakeholders should prepare for a new evidence development and commercialization environment.
Forthcoming Regulatory Changes for Lab-Developed Tests
This spring, the FDA will issue a rule to begin regulating LDTs as medical devices. A multi-faceted legislative, legal and market response is anticipated.
Video: Avalere’s Insights on Rare Disease
In this installment of our 2024 Trends Influencing Rare Disease series, Avalere experts summarize key learnings for pharmaceutical companies to consider.
Video: How the FDA and Market Access Impact Rare Disease Drug Access
In this installment of our 2024 Trends Influencing Rare Disease series, Avalere experts dive into access drivers and considerations in the rare disease space.
Video: How to Think About Rare Diseases in the US and Globally
In this installment of our 2024 Trends Influencing Rare Disease series, Avalere experts provide an introduction into regulatory approaches to rare diseases.
Status of US Prescription Drug Importation Pathways
Recent FDA authorization of Florida’s Section 804 Importation Program has prompted increased focus on importation pathways.
Use of Dispense as Written Codes After Generic Entry
Analysis of Dispense as Written codes highlight that many factors influence stakeholder preferences for brand or generic drugs after loss of exclusivity.
Complete Response Letters: Implications for Product Access
Receiving a complete response letter is not a rejection, but it introduces important business questions for product launch planning.
FDA Supply Chain and Quality Balancing Act: What’s Next?
The industry should expect and prepare for changes to regulatory oversight of drug supply chains and quality.
Proposed Shifts in Oversight of Lab-Developed Tests
The FDA proposed to begin regulating LDTs as medical devices over the next 5 years. This has important implications for market dynamics and clinical care.
Opportunities for Rare Disease Drug Manufacturers
Rare disease drug manufacturers can advance clinical development through FDA programs aimed at facilitating pipeline innovation.
Clinical and Market Differentiation of Combination Products
Combination products may offer differentiation but require consideration of unique decisions with regulatory and market access implications.