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The annual report by the Office of Pharmaceutical Quality (OPQ) lists several updates regarding FDA’s CGMP inspection program along with several interesting factoids about the status of the drug supply chain in the US. The FDA has been developing a new inspection program for the last few years and the report summarizes what it has … Read more

Observational studies such as collection and evaluation of Real World Data (RWD) collected from medical records and other uncontrolled sources could play a crucial role in advancing medical knowledge by shedding light on disease incidence, prevalence, natural history, prognosis, and aiding in the development of clinical risk scores. However, when it comes to evaluating the … Read more

As longform artificial intelligence (AI) algorithms like ChatGPT become popular, these would obviously be used by authors to write, edit, or involve in other ways in the creation of manuscripts. To address the use of AI in scientific publication, the International Committee of Medical Journal Editors (ICMJE) revised the instructions to authors to not include … Read more

In its ongoing efforts to show how sponsors of market approval applications can provide alternate data to reduce non-clinical studies, FDA released a guidance describing Generally Accepted Scientific Knowledge (GASK) which can be used in lieu of animal studies. In the process, FDA also highlighted how subjective this assessment can be, and how it would … Read more

Decentralized or Virtual clinical trials have emerged as a game-changing approach to study the efficacy and safety of new treatments and interventions. But the regulatory expectations from these trial designs were not clarified. That is, till now. With two guidance documents released within the last month, the FDA has expressed its strong support for trial … Read more

Patients cannot read the fine print, called package insert (PI), accompanying their prescription drugs, leading to medication errors which in turn results in treatment failures and other serious consequences for the patients. To address that, FDA is proposing a new rule to require simplified drug information, called “Patient Medication Information (PMI)” for all prescription drugs … Read more

After a hiatus of more than 3 years, the face-to-face (FTF) meetings between FDA and industry applicants will start in about 2 weeks. However, these meetings will not be like the widely attended meetings of the pre-pandemic years, but for selective types of discussions and on a hybrid format.  Meetings with the FDA are a … Read more

An independent survey listed 10 most expensive drugs or biologics in the US market and all of them are orphan drugs. With the annual cost of between $840K to $3.5 million, most of these drugs are quite profitable despite very few patients among the very few eligible patients who could either be covered by their … Read more

Two new FDA Guidance Documents released last week describe in great details the various regulatory and scientific considerations for developing drugs and biologics for children. Two laws passed more than 20 years ago for pediatric drug developments mandate that all new drug approval applications either contain pediatric data or the plan to generate such data … Read more

Almost exactly 2 years after the launch of its clinical trial business in May 2021, CVS announced this week that it is shutting it down. While the company did not announce specific reasons for its decision, public information shows that the company was unable to successfully harness its access to tens of millions of patients … Read more