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.

Amanda Tripp

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.

Mark von Eisenburg

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.

Sarah Moselle

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.

Sarah Moselle

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.

Miron Dilmanian

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.

Mark von Eisenburg

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.

Kylie Stengel

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.

Kelly George

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.

What the Rollover from Drugs to Biologics Means

On Monday, March 23, over 90 products that had historically been regulated as drugs were deemed to be licensed as a biologic. This includes insulin products. During the past several years, the Food & Drug Administration (FDA) has released guidance about their interpretation of the provision to guide sponsors and provide information about what to expect for the transition.

COVID-19 Supply Chain Considerations

As the novel coronavirus disease (COVID-19) continues to change daily life, concerns about the impact on global supply chains and possible drug shortages have increased. Additionally, changes to FDA processes may limit its ability to perform essential drug related activities.

Omar Hafez

FDA’s Priorities and Approach for Homeopathic Drug Products

On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA approval. The FDA has not approved a single homeopathic product thus far. The agency is currently restructuring its enforcement and regulatory priorities in this space.

FDA Launches Global Platform of CURE ID Application

A new FDA resource is available to identify drug candidates for additional study and serve as a resource to shape medical decisions.

FDA Reform: It’s Time to Act, But Not as an Independent Agency

As former federal officials, Dan Troy, David Beier, and I share our perspectives on the call by former FDA officials representing both political parties to make the FDA an independent agency separate from its parent, HHS.

Zachary Zalewski

Landscape for Diagnostics Will Continue to Change in 2019

While precision medicine is expected to revolutionize patient therapy, the increasing complexity of diagnostics is leading policymakers to revamp the way these tests are regulated and paid for.

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