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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

As Sarepta looks towards another controversial FDA approval for a new treatment for DMD, the accelerated approval pathway is once again being debated for its merits and abuses. Without major regulatory changes, there is not much that the FDA can do or want to do, while patients potentially get hurt both physically and financially. A … Read more

The last 5 years have seen extensive use of artificial intelligence (AI) algorithms for drug and medical device development. Till earlier this year, the regulatory discussions about AI were focused on medical devices but now FDA has released two white papers of use of this technology for the drugs and biologics, as well. FDA recognizes … Read more

As of today, 11 May 2023, the Public Health Emergency (PHE) for COVID-19 declared in January 2020 expired but this would not affect the various products authorized for Covid via Emergency Use Authorization (EUA). This is because under US laws, the PHE and the EUA are not linked. PHE refers to specific emergency measures to … Read more

The recent allegations of a NIH-funded researcher in Columbia conducting primate studies without proper ethics approval and conduct non-compliant with good laboratory practices (GLP) for non-clinical research have sparked outrage in the scientific community and raised important questions about the ethical standards that must be upheld in scientific research, in general, and US government funded … Read more