How does the FDA decide when a booster is needed?
FDA, CDC, and NIH are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data -- which can include data from specific pharmaceutical companies, but does not rely on those data exclusively.
What devices are eligible for step?
Devices that are eligible for STeP, unlike those that are eligible for the Breakthrough Devices Program, may include devices that are intended to treat or diagnose diseases or conditions that are non-life-threatening or reasonably reversible.
Are We prepared for booster doses?
We are prepared for booster doses if and when the science demonstrates that they are needed. The CDC-FDA statement appeared to be a direct slap-down -- especially to Pfizer. But why would the agencies respond so quickly and forcefully?
What happens if the FDA does not respond to my request?
It is helpful when a sponsor is available and responsive to any FDA requests for additional information throughout the review timeline. If the FDA does not receive the information requested promptly, it may result in denial of the program entrance request.
What is STEP in medical?
What is the Safer Technologies Program (STeP)? The Safer Technologies Program (STeP) is a voluntary program for certain medical devices and device-led combination products that are reasonably expected to significantly improve the safety of currently available treatments or diagnostics that target an underlying disease or condition associated ...
What happens if the FDA does not receive the information requested promptly?
If the FDA does not receive the information requested promptly, it may result in denial of the program entrance request.
What information should be included in a STEP request?
The FDA recommends that your request include information to describe the device, the proposed indications for use, expected safety improvement, regulatory history, how your device meets the STeP objectives, and what type of marketing submission you plan to submit to the FDA for your device. Learn more about what to include in your request in ...
Why is the breakthrough device not eligible?
Not eligible for the Breakthrough Devices Program due to the less serious nature of the disease or condition treated, diagnosed, or prevented by the device. Section IV.C. (1) Second Eligibility Factor.
Who can identify devices that could be good candidates for the Safer Technologies Program?
The FDA may identify devices that could be good candidates for the Safer Technologies Program and recommend that sponsors of such devices consider applying to the program.
What is the FDA approved treatment for multiple myeloma?
The Food and Drug Administration’s (FDA) recent approval of the first CAR-T cell therapy, Abecma (idecabtagene vicleucel), for the treatment of multiple myeloma is extremely significant for adults who have not responded to at least four lines of therapy, according to an expert from the Dana-Farber Cancer Institute.
When will Abecma be approved?
April 30, 2021. Ryan McDonald. The Food and Drug Administration’s recent approval of Abecma is an extremely significant development for patients with heavily pretreated multiple myeloma, according to an expert from the Dana-Farber Cancer Institute.
Is Abecma approved for patients?
Although the approval of Abecma is indicated for patients who have had at least four prior lines of therapy, there are multiple studies currently underway evaluating it in the second- and third-line setting, Munshi mentioned. Additionally, there is another study evaluating it in an upfront setting focusing on high-risk patients.
Is abecma a standard of care?
Abecma has the potential to become a standard of care for a heavily pretreated population with multiple myeloma, according to Munshi. He likened it to cancer centers experienced in performing allogeneic stem cell transplants.
Is abecma good for MRD?
The approval is a great blessing for both physicians and patients, according to Munshi. He noted that Abecma is one therapy that leads to MRD negativity at a late stage and should as well at an earlier stage. “I believe this is the first step in the near future to a cure,” he concluded.
Is Moderna a CDC drug?
Pfizer ( NYSE:PFE) and Moderna ( NASDAQ:MRNA) have enjoyed good working relationships with both the Centers for Disease Control & Prevention (CDC) and the U.S. Food and Drug Administration (FDA). The FDA granted quick approvals to both drugmakers' COVID-19 vaccines last December. The CDC has encouraged Americans to receive both vaccines.
Does Pfizer support boosters?
Pfizer and Moderna have recently expressed support for booster doses. The CDC and FDA issued a joint public statement last week that appeared to contradict this view. Here's why the two federal agencies just slapped down Pfizer and Moderna. Image source: Getty Images.
A Quick and Forceful Response
- Just with any therapy, Munshi mentioned, there are some toxicities associated with the use of Abecma. The most common include cytokine release syndrome (CRS), which happens in approximately 90% of patients, and neurotoxicity. However, approximately 5% to 6% of CRS were serious or severe and around 3% of neurotoxicity were serious or severe. “Toxici...
Reconciliable Differences
Why All of This Matters