We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. A phone call to FDA requested information about the number of Remote Interactive Evaluations (RIEs) that FDA has performed at drug manufacturing facilities since it announced in April …
On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” It finalized a draft guidance published in 2022. Although fairly short and light on substance, it has the potential to …
Please sing to the tune of “Honesty,” by Billy Joel: Nitrosamines, it’s such an ugly word, In pharmaceuticals’ impurity. Nitrosamines are hardly ever good, Now FDA has issued policy. Failure to detect nitrosamines, failure to notify FDA when nitrosamines appear in finished drug products, failure to identify impurities in drugs …
As we noted in our previous blog post available here, Quidel’s Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Antigen+ FIA Control Swab Set’s De Novo, now opens the door for follow-on 510(k) submissions that declare this product as their predicate, if the product meets …
On March 8th FDA granted Quidel’s De Novo for the Sofia 2 SARS Antigen+ FIA and Sofia 2 SARS Antigen+ FIA Control Swab Set. This announcement is the first traditional marketing authorization for a non-PCR based test to detect SARS-CoV-2. The authorization of this De …
FDA recently published the final guidance document “Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” This final guidance provides recommendations to original applicants and holders of approved applications for human drugs and certain biological products …
On September 29, 2022, FDA’s Center for Biologics Evaluation and Research (CBER) and the Office of Tissues and Advanced Therapies (OTAT) held a town hall to answer questions related to gene therapy chemistry, manufacturing, and controls. Wilson Bryan opened this new forum for direct agency …
Similar to what was done with COVID-19, the National Institute for Health (NIH) Rapid Acceleration of Diagnostics (RADx) initiative has established a Monkeypox Independent Test Assessment Program (ITAP) and it currently accepting new proposals on a rolling basis to address the outbreak. The program began …
We are almost three years into the public health emergency as a result of the COVID-19 pandemic, and still only have 19 rapid antigen tests authorized for at-home use in the United States. The primary barrier to bringing new antigen tests to market has been …
We return to the subject of FDA’s role in effectively blocking most rapid antigen COVID tests from the U.S. market. There has not been a new rapid antigen test authorized during the past six weeks. As we mentioned in our previous post, NIH’s ITAP program was …
Last November, we explained FDA’s role in blocking over-the-counter (OTC) rapid antigen tests from the American market. We identified as the main culprit FDA’s requirement that these tests achieve 80% sensitivity (positive percent agreement or PPA) even when a required percentage of low positive patients …
In England, over‑the‑counter (OTC) rapid antigen tests for COVID are widespread and available at low cost. In America, these tests are scarce and relatively high‑priced. Why is that? Background Rapid tests for COVID-19 are fast, inexpensive to manufacture, and a relatively easy method to detect the presence …
During the February 3rd meeting of the IVD Town Hall that OHT-7 has been hosting since early on the pandemic Office Director Timothy Stenzel proudly proclaimed: We have also really have ramped up our decisions. So we are currently over the last week averaging about nine …
We have previously posted about the heartache and anxiety that is the EUA process (here). Companies are waiting months for feedback from FDA and are frequently given comically short timelines for response. Another layer in this onion of poor management is the growing gap between the …
On March 31st, 2021 BARDA launched a competition to design tomorrow’s mask. The Mask Innovation Challenge, at its core, is about finding new mask designs that can be mass produced at a low cost and provide general protections against respiratory pathogens. One of the lessons …
