iwewlkws Over the last 3 decades, expanded access or emergency use treatments have become quite common and clinical experience from expanded use of investigational products has even been used to provide additional safety data to the FDA and enrich the real-world evidence (RWE), particularly for rare diseases. But use of expanded access protocols also raises concerns … Read more
Use of Artificial Intelligence (AI) is being explored for several aspects of manufacturing FDA regulated products which raises new concerns that must be considered according to a Discussion Paper released by FDA this week. FDA would like the industry to comment on these concerns so suitable regulatory policies can be created for such systems. There … Read more
Artificial Intelligence systems such as ChatGPT can be used for creating summaries, discussions, and generating ideas. Can that be expanded to designing new drugs and finding new uses or previously approved drugs? ChatGPT uses publicly available information to summarize and pseudo-analyze specific questions posed to it providing seemingly intellectual assessments. The software can theoretically be … Read more
A heartrending article by a former assistant secretary of public affairs and deputy chief of staff at the Department of Health and Human Services, highlights the disconnect between FDA’s requirements for critical drug approval and patients’ need. This is not the only case of its kind where patients and physicians complain of the opacity of … Read more
A couple of weeks back Pfizer announced that it is dropping about 3500 patients recruited to its Phase 3 clinical trial for a vaccine for Lyme disease due to GCP compliance issues related to its “clinical trial site operator”, Care Access. This is not normal; rather this is likely the only incidence of its kind … Read more
Under the drug pricing competition provisions of the US regulations, for the last few years FDA has implemented several programs to encourage multiple manufacturers for each generic drug product. However, these efforts are limited to the finished product manufacturers only and not to the ingredient suppliers. Lack of competition for API manufacturing creates a vulnerability … Read more
The review by IRBs of clinical protocols is a well-recognized measure to assure protection of clinical trial participants all over the world. Per the regulations, IRBs hold a very important place in assuring ethical conduct of clinical trials, and act as surrogates to the FDA for oversight of clinical trial conduct. But are the IRBs … Read more
FDA approval of a new drug is often touted as a gold standard for regulatory approval for that drug. However, about 50% of the times, regulators in Canada, Europe, Australia and the United Kingdom, rejected the approval of that same drugs due to insufficient benefit or unreasonable risk. Most of the drugs rejected by other … Read more
A new Guidance released this week describes the clinical testing requirements for products intended for treating neonatal diseases. Specifically, the guidance requires 2 years safety studies for neurologic, sensory, and developmental evaluations of new drugs, biologics or medical devices. While the guidance is obviously well-intentioned, it does raise doubts about the feasibility of such studies … Read more
All submissions made to the FDA by an organization are reviewed and tallied to previous submissions made by the same organization, person, locations and other identifiers. The FDA keeps track of all submissions and any deficiencies identified are tracked as well to assure that non-compliance is addressed. Occasionally events happen that demonstrate this fact. Between … Read more
