Day: August 26, 2021

Since the approval of the Alzheimer’s Drug, Adulhelm, almost three months ago, the accelerated approval pathway (AAP) has been criticized, to a large extent, unfairly. The criticism misses the lax enforcement of the well-established rules for the pathway by the FDA for such decisions. The AAP requires demonstration of benefits of a new drug in … Read more

Doctors often prescribe FDA-approved drugs to patients who may not be eligible for them based on the labelled claims for the drug, on a case-by-case basis. Such off-label treatment is an important part of patient care in the absence of a specific approved treatment. Now that the Pfizer’s COVID vaccine has been approved, concerned parents … Read more