Oncology patients face a difficult journey — a frightening diagnosis followed by intricate and oftentimes burdensome treatment regimens with uncertain outcomes. One patient struggles to take the correct dosage at the prescribed times through the “brain fog” caused by his...
Expertise: Consulting 214 results
In a previous blog post, we discussed some significant changes to over-the-counter (OTC) product regulations put into place by the passage and signing into law of the CARES Act. The previous post focused on the most attention-getting OTC component of...
Tucked away in the nearly 900 pages of the Coronavirus Aid, Relief, and Economic Security (CARES) Act just passed is the addition of Section 505G to the Food, Drug, and Cosmetic Act. This section makes substantial changes to the statutory structure and...
As a regulatory affairs professional advising various stakeholders on the interpretation and implementation of guidance documents from the FDA, I can safely say that the task is challenging in the best of cases. FDA guidance documents have a tendency to...
In response to the newly released U.S. Food and Drug Administration (FDA) guidance on COVID-19, the Statistics Department at Premier Research has committed to highlight specific and necessary actionable considerations that directly address key FDA recommendations in the guidance. These considerations call attention...
On January 31, 2020, the Secretary of Health and Human Services (HHS) declared a national emergency to combat the COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2. As a result, the FDA is authorized to grant Emergency Use Authorizations (EUAs)...
During these challenging times when the world is focused on COVID-19 and the matters at hand, it’s understandable if you didn’t take much notice of March 23 as a significant date – one that’s been on the FDA’s radar for...
In response to the Coronavirus Disease 19 (COVID-19) pandemic, the scientific community, industry, and regulatory agencies are pulling together to facilitate the development of diagnostic tests, drugs, and vaccines to help prevent the spread of the disease. The timelines for...
In March 2020, at the start of the COVID-19 pandemic, the FDA issued guidance on the conduct of clinical trials. “The FDA released this guidance to emphasize that at all times, patients’ safety should continue to be at the forefront of considerations,”...
As we continue to face health emergencies and imminent threats to our safety and well-being, the medical community is tasked with bringing solutions to the patients in an expedited and safe manner. One such opportunity is to partner with the...