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.
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.
Digital Health Technology Access Requires Early FDA, Payer Engagement
As digital health technologies evolve, manufacturers seek clarity on regulatory pathways and access channels.
Pre-Approval Information Exchange Aids Manufacturer–Payer Engagement
Clarifications in the PIE Act may shift manufacturer-payer engagement strategy and improve coverage and reimbursement of new drugs and devices.
FDA Human Foods Program Redesign Would Centralize Food Safety Efforts
Amid growing safety issues in America’s food supply, the FDA’s proposal for a new Human Foods Program presents opportunities for stakeholders to act.
505(b)(2) Changes That Generic Manufacturers Should Know
Regulatory changes to the 505 (b)(2) pathway will impact the go-to-market strategy for follow-on products that are not currently deemed therapeutically equivalent to the reference product.
CMS Finalizes Discarded Drug Refund Requirements with Key Changes
The MPFS final rule implements the discarded drug refund requirement for certain single-use physician-administered drugs, presenting risks to manufacturers of these products.
Accelerated Approval of Drugs Gives Underserved Beneficiaries Access
A new Avalere analysis shows the Accelerated Approval pathway provides access to underserved Medicare beneficiaries across a range of conditions with unmet needs.
FDA-CMS Collaboration: History and Future Outlook
FDA and CMS have historically had complementary roles, yet prior collaboration between the agencies generally has been limited.
Ensuring Patient Access by Navigating Decisions at FDA and CMS
The FDA and CMS have historically had complementary roles. Recent activity highlights how their unique functions affect access to medicines.
Global Regulatory Agilities During the COVID-19 Pandemic
Avalere reviewed innovative regulatory approaches deployed during the pandemic, their impact on a diverse set of stakeholders, and how they could be sustained.
Ex-US Approaches to Drug Accelerated Approval
International methods of expedited approval offer approaches that policymakers may adopt to reform the US system, as signaled in recent legislative proposals.
Advancing the Use of Digital Health Technologies
The digital health technologies (DHTs) market is projected to grow from $3.5 billion in 2020 to $23.5 billion by 2030. Stakeholders must navigate complex pathways as the FDA develops regulatory frameworks for DHTs.
User Fee Amendment Reauthorization: What’s Next?
The first Congressional hearings for user fee reauthorization begin on February 3, 2022, and current legislative authority for UFAs will expire in September 2022.
Understanding the History and Use of the Accelerated Approval Pathway
Amid recent policy focus on the accelerated approval pathway and questions regarding the pathway’s evidentiary standards and decision framework, Avalere reviewed the history, process, and use of this pathway to date and the potential future use of accelerated approval for pipeline products.
How Lessons from COVID-19 Can Improve Access to Future Medicines
Crises often drive change at a pace not thought feasible in normal times. The COVID-19 pandemic has been no exception, bringing the accelerated development and emergency approval of vaccines, the wide implementation of telehealth, and potentially permanent changes to the way that global business is conducted.
FDA Approach to Oversight of COVID-19 Therapeutics Has Evolved
While the COVID-19 pandemic continues to spread around the world, FDA has been balancing taking action to accelerate development of COVID-19 therapeutics and vaccines, while concurrently maintaining day to day activities to ensure proper oversight of current and future products on the market for all other unmet medical needs.
After the Rollover from Drugs to Biologics: What Remains Uncertain?
The Biologics Price Competition and Innovation Act (BPCIA) mandates that specific protein products that were approved as drugs under section 505 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) be licensed as biologics under section 351 of the Public Health Services Act (PHS Act) as of March 23, 2020.
What the COVID-19 Pandemic Will Mean for Drug Development
In response to the COVID-19 pandemic, FDA has announced actions that may have much broader implications for drug development, lifecycle management, and oversight.