The Federal Register (FR), in a pre-publication notice today (here), outlined the general process for the authorization and issuance of emergency use authorizations (EUAs) similar to the ones they have been issuing during the COVID-19 pandemic. The FDA is (as are other Agencies of the government) authorized to issue EUAs and are required to publish […]
How many times have you had a question about the listings in the Orange Book (OB) but were not sure who to ask? Well, a lot of people have obviously stood in your shoes, as this draft guidance titled Orange Book Questions and Answers Guidance for Industry (here) publishes a great Q&A from those who […]
Nothing is normal these days. We’ve learned to be creative in everything we do during this crisis, from where and how we work, to finding scarce resources in both our work and personal lives. Rules have changed to accommodate circumstances, and expectations have been colored by those changes. Take for example FDA’s Emergency Use Authorization […]
Most of the diagnostic tests that are currently being marketed for detecting COVID-19 are subject to emergency use authorizations (EUAs). Today, the FDA published a listing of commercial manufacturers of serological tests who had previously provided notification to FDA under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests but have […]
In a move that has me puzzled, the Government’s award of the contract to a company that does not appear on the FDA’s list of DMF holders, and is not found as a holder of any approved ANDA or NDA in the FDA’s Orange Book seems a bit strange. According to a FOX news story […]
The FDA continues to make drug compounding a high priority and will enforce the requirements of the DQSA. The FDA was very busy last week and, on May 13, 2020, Janet Woodcock, MD, Director, Center for Drug Evaluation and Research, issued two letters, one responding to a citizen’s petition (here) and one announcing the availability […]
Drs. Anthony Fauci (National Institute of Allergy and Infectious Diseases, NIH), Robert Redfield (Director, CDC), Stephen Hahn (Commissioner, FDA), and Brett Giroir (Assistant Secretary for Health, HHS) testified this morning before the Senate Committee on Health, Education, Labor, and Pensions, chaired by Senator Lamar Alexander. The goal of the hearing is to identify what went […]
Whether you’ve been through an FDA inspection before or not, it’s highly recommended that you and your organization prepare for their visit sometime in the not-too-distant future. But despite your best efforts, it’s a very distinct probability that you will receive some inspectional observations. While conduct during an inspection is very important, your behavior post-inspection, […]
We all know that the most expensive prescription is the one the patient does not take. Certainly, there are several factors that impact the decision for a patient to fill a prescription. Failure to comply with medication directions can also impact the health of the patient. These failures to comply can lead to more expensive […]
Although though we are in the grips of a pandemic and our attention is focused on the development of treatments and vaccines for COVID-19, manufacturing of drug products to treat other conditions is continuing, and GMPs must still be maintained. Sponsor companies continue to manufacture products and are still dependent upon products and services from […]
