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FDA-Approved Labeling: Is Enough Enough?

FDA Law Blog

It’s important to note here that the warnings and precautions listed in the acetaminophen labeling complied with FDA’s Pregnancy Rule (which applies to all OTC systemic products), stating “if pregnant or breast-feeding ask a health professional before use,” and with the acetaminophen OTC Monograph and the relevant NDAs.

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Analysis of primary care prescription trends in England during the COVID-19 pandemic compared against a predictive model

BMJ

We used the first six years of the dataset to form a predictive model using Holt-Winters forecasting (a time series predictive method based on trends and seasonality), and then compared the observed data from November 2019 to November 2020 with the model to assess the impact of the COVID-19 pandemic on prescribing.