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.
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.
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.
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.
On October 24, the FDA released a draft guidance describing the intended risk-based approach for regulatory actions toward homeopathic drug products marketed in the United States without the required FDA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.
A new FDA resource is available to identify drug candidates for additional study and serve as a resource to shape medical decisions.
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.
New call center also supports investigational requests.
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.
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.
The US Food and Drug Administration (FDA) makes its medical product marketing approval decisions based on a risk–benefit determination of safety and effectiveness.
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 reliance on the average number of FDA drug approvals to calculate budget impact thresholds leads to significant variability.
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.
Avalere evaluated payer policies for biologics when biosimilars are available.
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.
Most people are familiar with generic drugs as less costly alternatives to drugs whose patents have expired.
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.
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.
In its new regulatory framework for regenerative medicines released in November 2017, FDA takes a flexible approach, creating opportunity for manufacturers.
The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, calls on FDA to examine underlying barriers to access to investigational drugs.