FDA Regulatory Pathways
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.
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.
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 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.
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On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA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.
Where We Stand with Generic Drug Approvals and Authorized Generics in 2019
Patient access to high-quality, low-cost generic drugs continues to increase, due to a record number of generic approvals by the FDA in fiscal year 2019.
Bolstering Patient Access: FDA’s Project Orbis Attains First Joint International Drug Approval
New call center also supports investigational requests.
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.
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.
What Is a Complete Response Letter?
The US Food and Drug Administration (FDA) makes its medical product marketing approval decisions based on a risk–benefit determination of safety and effectiveness.
FDA Seeks Stakeholder Input on How to Enhance Biosimilars and Interchangeable Biologics Market
Earlier this week, the Food & Drug Administration (FDA) released a Part 15 public hearing announcement and request for comment on how the FDA can facilitate greater availability while balancing competition and innovation for all biologics.
ICER’s Use of FDA Approval Volume to Calculate Budget Impact Thresholds: A Scenario Analysis
ICER’s reliance on the average number of FDA drug approvals to calculate budget impact thresholds leads to significant variability.
Podcast: E3 – Real-World Evidence: Is It a Game Changer for the FDA?
Tune in to the final podcast in our series as we discuss 3 steps companies should complete now to take advantage of the FDA’s priority to advance the adoption of RWE to support agency decision-making.
Use of Step Through Policies for Competitive Biologics Among Commercial US Insurers
Avalere evaluated payer policies for biologics when biosimilars are available.
Two-Year Countdown Begins for FDA “Roll-Over” of Biologics Currently Regulated as Drugs
In just two years, on March 23, 2020, biologics currently regulated as drugs will transition to being regulated as biologics. Many aspects of how FDA will implement this transition have yet to be established.
Issue Brief: The Elements of a Competitive Biologics Market
Most people are familiar with generic drugs as less costly alternatives to drugs whose patents have expired.
Three Ways the FDA Can Facilitate Claims of Interchangeability
In the US, an interchangeability designation by the Food & Drug Administration (FDA) is perceived as the holy grail in biosimilars development by some and yet regarded as irrelevant by others.
Podcast: E1 – Real-World Evidence: Is It a Game Changer for the FDA?
Tune in to our new real-world evidence podcast series, where Avalere experts explore real-world evidence as a disruptive force in healthcare. In Episode 1, we focus on why RWE is such a hot topic.
FDA Prepares for the Next Generation of Regenerative Medicines
In its new regulatory framework for regenerative medicines released in November 2017, FDA takes a flexible approach, creating opportunity for manufacturers.